Category: Uncategorized
MBX Biosciences Appoints Steven Ryder, M.D., to Board of Directors
CARMEL, Ind., February 5, 2024 — MBX Biosciences, Inc., a clinical-stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced the appointment of Steven Ryder, M.D, Chief Medical Officer of Rallybio, to its Board of Directors. Dr. Ryder is an accomplished biopharmaceutical executive with over 35 years of global drug development experience and industry leadership.
“I am delighted to welcome Steve to our Board of Directors, and we look forward to his leadership as we progress our pipeline of novel therapies for people with rare endocrine disorders,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “Steve’s deep experience in global drug development, particularly in rare diseases, will be invaluable as we continue growing the company and advancing our Precision Endocrine Peptide (PEP) platform for patients with hypoparathyroidism, post-bariatric hypoglycemia and obesity.”
Dr. Ryder currently serves as Chief Medical Officer of Rallybio, a biotechnology company identifying and accelerating the development of transformative therapies for patients with severe and rare disorders. Prior to Rallybio, Dr. Ryder was the Chief Development Officer at Alexion Pharmaceuticals, Inc. Before this, he was the founding President of Astellas Pharma Global Development, Inc. Prior to Astellas, he served at Pfizer for over 20 years in positions of increasing responsibility, including head of worldwide clinical development. Dr. Ryder is a past-President of the American Society of Clinical Pharmacology and Therapeutics and has held leadership positions in the Health Section Governing Board, Regulatory Executive Committee for the board of the Biotechnology Innovation Organization (BIO), and the Science and Regulatory section of the Pharmaceutical Research and Manufacturers of America (PhRMA). In addition, Dr. Ryder has served as the industry representative on the U.S. Food and Drug Administration’s Metabolic/Endocrine Drugs Advisory Committee, and has held board positions at Reata Pharmaceuticals and Levo Therapeutics. Dr. Ryder earned his M.D. from the Icahn School of Medicine at Mount Sinai.
“I am honored to join the MBX Board during this exciting period of growth for the Company,” said Dr. Ryder. “I’m impressed by the significant potential of MBX’s differentiated PEP platform to treat endocrine and metabolic disorders, and look forward to working closely with this experienced team as we advance our promising candidates through the clinic.”
About MBX Biosciences
MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide™ (PEP™) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives. MBX is advancing a pipeline of PEPs for clinically validated targets designed to deliver superior pharmaceutical properties and overcome key limitations of native peptide therapeutics. MBX’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of hypoparathyroidism (HP), MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH) and multiple discovery and pre-clinical candidates in development for the treatment of obesity. The company is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, Norwest Venture Partners, OrbiMed, RA Capital Management and Wellington Management. MBX is based in Carmel, Indiana. To learn more, please visit the company website at www.mbxbio.com and follow us on LinkedIn and X (formerly Twitter).
Media Contact:
Will Zasadny
Inizio Evoke Comms
[email protected]
619-961-8848
Investor Contact:
Irina Koffler
LifeSci Advisors
[email protected]
917-734-7387
MBX Biosciences to Participate in Oppenheimer 34th Annual Healthcare Life Sciences Conference
CARMEL, Ind., January 31, 2024 — MBX Biosciences, Inc., a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced that Kent Hawryluk, President and Chief Executive Officer, will present at the virtual Oppenheimer 34th Annual Healthcare Life Sciences Conference on Wednesday, February 14th, 2024, at 12:40 p.m. ET and the company will host one-on-one investor meetings during the conference.
About MBX Biosciences
MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide™ (PEP™) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives. MBX is advancing a pipeline of PEPs for clinically validated targets designed to deliver superior pharmaceutical properties and overcome key limitations of native peptide therapeutics. MBX’s pipeline includes its lead product candidate MBX 2109, in Phase 2 development for the treatment of hypoparathyroidism (HP), MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH) and multiple discovery and pre-clinical candidates in development for the treatment of obesity. The company is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, Norwest Venture Partners, OrbiMed, RA Capital Management and Wellington Management. MBX is based in Carmel, Indiana. To learn more, please visit the company website at www.mbxbio.com and follow us on LinkedIn and X (formerly Twitter).
Media Contact:
Will Zasadny
Inizio Evoke Comms
[email protected]
619-961-8848
Investor Contact:
Irina Koffler
LifeSci Advisors
[email protected]
917-734-7387
MBX Biosciences to Participate in 42nd Annual J.P. Morgan Healthcare Conference
CARMEL, Ind., December 20, 2023 — MBX Biosciences, Inc., a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced that Kent Hawryluk, President and Chief Executive Officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8th, 2024, at 11:30 a.m. PST and the Company will host one-on-one investor meetings during the conference.
About MBX Biosciences
MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide™ (PEP™) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives. MBX is advancing a pipeline of PEPs for clinically validated targets designed to deliver superior pharmaceutical properties and overcome key limitations of native peptide therapeutics. MBX’s pipeline includes its lead product candidate MBX 2109, which has completed Phase 1 development for the treatment of hypoparathyroidism, and MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia. The company is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, Norwest Venture Partners, OrbiMed, RA Capital Management and Wellington Management. MBX is based in Carmel, Indiana. To learn more, please visit the company website at www.mbxbio.com and follow us on LinkedIn and X (formerly Twitter).
Media Contact:
Ian Stone
Evoke Canale
[email protected]
619-849-5388
Investor Contact:
Irina Koffler
LifeSci Advisors
[email protected]
917-734-7387
MBX Biosciences Announces Appointment of Michelle Graham as Chief Human Resources Officer
CARMEL, Ind., November 1, 2023 — MBX Biosciences, Inc., a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced the appointment of Michelle Graham as Chief Human Resources Officer. Ms. Graham is a seasoned global executive with 25+ years of experience leading human resources across a broad range of companies in the biopharmaceutical and healthcare industries.
“Michelle is an exceptionally experienced human resources executive with an impressive track record of leading global teams, developing and executing HR strategies, and fostering a diverse and inclusive culture,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “Her breadth of experience building and supporting biopharma companies at various stages of development will be highly impactful as we are poised to enter an exciting growth phase for the Company. We are pleased to welcome Michelle to MBX and look forward to leveraging her expertise.”
Prior to joining MBX, Ms. Graham served as Chief Human Resources at Albireo Pharma Inc., a biopharmaceutical company recently acquired by Ipsen, where she supported strategic direction and global business growth. Prior to Albireo, Ms. Graham was Senior Vice President and Chief Human Resources Officer at TESARO, Inc., a biotechnology company acquired by GSK, and at Parexel International Corporation, a biopharmaceutical services company with 20,000 global employees. Earlier in her career, she held senior human resources and organizational development leadership positions across the healthcare industry, including at Bausch + Lomb and Bristol-Myers Squibb. Ms. Graham earned a Bachelor of Arts in Business Administration and Management and a Master of Human Resources and Labor Relations from Michigan State University.
“I am pleased to join the impressive MBX Biosciences team at this pivotal time in the company’s trajectory,” said Ms. Graham. “MBX has a strong patient-centered culture, and I look forward to supporting the continued growth of the organization in advancing its Precision Endocrine Peptide platform and ultimately serve patients in need.”
About MBX Biosciences
MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide™ (PEP™) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives. MBX is advancing a pipeline of PEPs for clinically validated targets designed to deliver superior pharmaceutical properties and overcome key limitations of native peptide therapeutics. MBX’s pipeline includes its lead product candidate MBX 2109, which has completed Phase 1 development for the treatment of hypoparathyroidism, and MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia. The company is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, Norwest Venture Partners, OrbiMed, RA Capital Management and Wellington Management. MBX is based in Carmel, Indiana. To learn more, please visit the company website at www.mbxbio.com and follow us on LinkedIn and X (formerly Twitter).
Media Contact:
Ian Stone
Evoke Canale
[email protected]
619-849-5388
Investor Contact:
Irina Koffler
LifeSci Advisors
[email protected]
917-734-7387
MBX Biosciences to Participate in Stifel 2023 Healthcare Conference
CARMEL, Ind., October 31, 2023 — MBX Biosciences, Inc., a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced that Kent Hawryluk, President and Chief Executive Officer, will present at the Stifel 2023 Healthcare Conference on Tuesday, November 14th, 2023, at 2:25 p.m. Eastern Time and will host 1-on-1 investor meetings.
About MBX Biosciences
MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide™ (PEP™) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives. MBX is advancing a pipeline of PEPs for clinically validated targets designed to deliver superior pharmaceutical properties and overcome key limitations of native peptide therapeutics. MBX’s pipeline includes its lead product candidate MBX 2109, which has completed Phase 1 development for the treatment of hypoparathyroidism, and MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia. The company is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, Norwest Venture Partners, OrbiMed, RA Capital Management and Wellington Management. MBX is based in Carmel, Indiana. To learn more, please visit the company website at www.mbxbio.com and follow us on LinkedIn and X (formerly Twitter).
Media Contact:
Ian Stone
Evoke Canale
[email protected]
619-849-5388
Investor Contact:
Irina Koffler
LifeSci Advisors
[email protected]
917-734-7387
MBX Biosciences Presents Positive Results from Phase 1 Study of MBX 2109 in Late-Breaking Oral Presentation at the American Society for Bone and Mineral Research Annual Meeting
MBX 2109 was generally well-tolerated across all dosing cohorts
MBX 2109 pharmacokinetics reflected the intended prodrug design and support once-weekly dosing
MBX 2109 increased albumin adjusted serum calcium and suppressed endogenous PTH(1-84)
CARMEL, Ind., October 16, 2023 — MBX Biosciences, Inc., a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced the presentation of positive results from its Phase 1 single and multiple ascending dose trial of MBX 2109 in healthy adults, as a late-breaking oral presentation at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting, held in Vancouver, Canada from October 13-16, 2023. MBX 2109 is the company’s long-acting parathyroid hormone (PTH) peptide prodrug in development for the treatment of hypoparathyroidism (HP).
“The positive safety and PK/PD results support the potential of MBX 2109 as the first once-weekly PTH prodrug for the treatment of HP and will inform dose selection in our planned Phase 2 trial in patients with HP, which is expected to begin this quarter,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “The current standard of care for HP does not target the underlying pathophysiology of the disease, and the success of the Phase 1 trial brings our development plan closer to delivering a potential best-in-class PTH therapy that may address this significant unmet need.”
The randomized, double blind, placebo-controlled Phase 1 trial enrolled 76 healthy adult volunteers and was designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) and multiple ascending doses (MAD) of MBX 2109. The primary endpoint was safety and tolerability, and secondary endpoints included PK and PD parameters. In the SAD portion of the study, healthy adult volunteers were randomized to receive either placebo or a single subcutaneous (SC) dose of MBX 2109 at 50 μg, 150 μg, 300 μg, 460 μg, or 600 μg. In the MAD portion of the study, healthy adult volunteers were randomized to receive four once-weekly SC doses of either placebo or MBX 2109 at 200 μg, 400 μg, 600 μg, or 900 μg.
Participant demographics across the cohorts were well-balanced. Single and repeat doses of MBX 2109 were generally well-tolerated, and the majority of treatment emergent adverse events were mild in severity. No MBX 2109 dose-related serious or severe adverse events, or deaths were observed.
The observed PK parameters following single and repeat doses of MBX 2109 reflected the intended prodrug design and support once-weekly dosing. Following multiple doses of MBX 2109, there was a dose-related increase in mean albumin-adjusted serum calcium concentrations and dose-dependent suppression in endogenous PTH(1-84), consistent with the expected PTH pharmacology.
MBX Biosciences is preparing for an End-of-Phase 1 meeting with the U.S. Food and Drug Administration this quarter, and the company anticipates initiating its Phase 2 trial of MBX 2109 in patients with HP thereafter.
About Hypoparathyroidism
Hypoparathyroidism (HP) is a rare endocrine disorder caused by a deficiency of parathyroid hormone that results in decreased calcium and increased phosphorus levels in the blood. HP affects approximately 200,000 individuals worldwide, most of whom develop the condition following damage to or removal of the parathyroid glands during thyroid surgery. HP is associated with a wide range of symptoms such as paresthesias, muscle cramps, seizures, an impaired quality of life, and an increased risk of comorbidities including kidney stones and impaired renal function. The goal of treatment is to maintain blood calcium levels in the low-normal range while preventing symptoms of hypocalcemia. Current standard of care consists of high doses of calcium supplements and active vitamin D, which may contribute to the risk of renal disease and do not address the underlying pathophysiology caused by a lack of parathyroid hormone.
About MBX 2109
MBX 2109 is an investigational long-acting parathyroid hormone peptide prodrug in development as a PTH replacement therapy for hypoparathyroidism. It was designed with the company’s novel, proprietary Precision Endocrine Peptide™ (PEP™) platform technology to provide sustained PTH activity with a convenient once-weekly dosing regimen. In July 2022, MBX 2109 received orphan drug designation from the U.S. Food and Drug Administration for the treatment of hypoparathyroidism. MBX aims to simplify and improve an individual’s disease management, while relieving both the symptoms of the disorder and long-term complications.
About MBX Biosciences
MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide™ (PEP™) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives. MBX is advancing a pipeline of PEPs for clinically validated targets designed to deliver superior pharmaceutical properties and overcome key limitations of native peptide therapeutics. MBX’s pipeline includes its lead product candidate MBX 2109, which has completed Phase 1 development for the treatment of hypoparathyroidism, and MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia. The company is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, Norwest Venture Partners, OrbiMed, RA Capital Management and Wellington Management. MBX is based in Carmel, Indiana. To learn more, please visit the company website at www.mbxbio.com and follow us on LinkedIn and Twitter.
Media Inquiries
Media Contact:
Ian Stone
Evoke Canale
[email protected]
619-849-5388
Investor Contact:
Irina Koffler
LifeSci Advisors
[email protected]
917-734-7387
MBX Biosciences Doses First Participant in Phase 1/2 Clinical Trial of MBX 1416 for the Treatment of Post-Bariatric Hypoglycemia
Topline results expected in 2H 2024
CARMEL, Ind., October 9, 2023 — MBX Biosciences, Inc., a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced that the first healthy adult participant has been dosed in its Phase 1/2 clinical trial of MBX 1416, the company’s long-acting glucagon-like peptide 1 (GLP-1) receptor antagonist, being developed for the treatment of post-bariatric hypoglycemia (PBH).
“We are pleased to advance our second innovative PEP candidate, MBX 1416, into the clinic with the initiation of the Phase 1/2 clinical trial,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “This milestone is an important step toward bringing a potential solution to patients with PBH, for which there are no currently approved therapies. We look forward to continuing enrollment, with topline results anticipated in the second half of 2024.”
The Phase 1/2 clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of MBX 1416 in healthy adult participants and patients with PBH. The trial is being conducted in the United States and is designed to enroll approximately 56 participants. The primary endpoint is safety and tolerability, and secondary endpoints include pharmacokinetics and pharmacodynamics. More information on the Phase 1/2 study can be found at www.clinicaltrials.gov, identifier NCT06036784.
About MBX 1416
MBX 1416 is an investigational long-acting glucagon-like peptide-1 (GLP-1) receptor antagonist in development as a potential first-in-class treatment for PBH. It was designed using the company’s novel, proprietary PEP platform to prevent the occurrence of severe hypoglycemia in individuals with PBH so they can lead healthier and more independent lives.
About Post-Bariatric Hypoglycemia
Post-bariatric hypoglycemia (PBH) is a rare and serious complication of bariatric surgery. PBH is characterized by repeated episodes of symptomatic hypoglycemia, triggered by excessive insulin levels following a meal, and can present as early as six months after Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy. Hypoglycemic episodes can occur multiple times per day and can periodically manifest with severe symptoms such as dizziness, confusion, loss of consciousness or seizure. The unpredictability of hypoglycemic episodes and their associated risks may meaningfully hinder daily activities. As a result, the patient burden can be substantial, and many individuals cannot drive, work or live alone. To date, there are no approved pharmacotherapies to treat PBH. As the use of surgery to address metabolic conditions continues to rise, the incidence of PBH is expected to increase, reinforcing the need for safe and effective therapies.
About MBX Biosciences
MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide™ (PEP™) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives. MBX is advancing a pipeline of PEPs for clinically validated targets designed to deliver superior pharmaceutical properties and overcome key limitations of native peptide therapeutics. MBX’s pipeline includes its lead product candidate MBX 2109, completing Phase 1 development for the treatment of hypoparathyroidism, and MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia. The company is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, Norwest Venture Partners, OrbiMed, RA Capital Management and Wellington Management. MBX is based in Carmel, Indiana. To learn more, please visit the company website at www.mbxbio.com and follow us on LinkedIn and Twitter.
Media Contact:
Ian Stone
Evoke Canale
[email protected]
619-849-5388
Investor Contact:
Irina Koffler
LifeSci Advisors
[email protected]
917-734-7387
MBX Biosciences to Showcase Results from Phase 1 Study of MBX 2109 in Late-Breaking Oral Presentation at the American Society for Bone and Mineral Research Annual Meeting
MBX 2109 was generally well-tolerated across all dosing cohorts
MBX 2109 pharmacokinetics reflected the intended prodrug design and support once-weekly dosing
MBX 2109 increased albumin adjusted serum calcium and suppressed endogenous PTH(1-84)
CARMEL, Ind., October 16, 2023 — MBX Biosciences, Inc., a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced the presentation of positive results from its Phase 1 single and multiple ascending dose trial of MBX 2109 in healthy adults, as a late-breaking oral presentation at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting, held in Vancouver, Canada from October 13-16, 2023. MBX 2109 is the company’s long-acting parathyroid hormone (PTH) peptide prodrug in development for the treatment of hypoparathyroidism (HP).
“The positive safety and PK/PD results support the potential of MBX 2109 as the first once-weekly PTH prodrug for the treatment of HP and will inform dose selection in our planned Phase 2 trial in patients with HP, which is expected to begin this quarter,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “The current standard of care for HP does not target the underlying pathophysiology of the disease, and the success of the Phase 1 trial brings our development plan closer to delivering a potential best-in-class PTH therapy that may address this significant unmet need.”
The randomized, double blind, placebo-controlled Phase 1 trial enrolled 76 healthy adult volunteers and was designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) and multiple ascending doses (MAD) of MBX 2109. The primary endpoint was safety and tolerability, and secondary endpoints included PK and PD parameters. In the SAD portion of the study, healthy adult volunteers were randomized to receive either placebo or a single subcutaneous (SC) dose of MBX 2109 at 50 μg, 150 μg, 300 μg, 460 μg, or 600 μg. In the MAD portion of the study, healthy adult volunteers were randomized to receive four once-weekly SC doses of either placebo or MBX 2109 at 200 μg, 400 μg, 600 μg, or 900 μg.
Participant demographics across the cohorts were well-balanced. Single and repeat doses of MBX 2109 were generally well-tolerated, and the majority of treatment emergent adverse events were mild in severity. No MBX 2109 dose-related serious or severe adverse events, or deaths were observed.
The observed PK parameters following single and repeat doses of MBX 2109 reflected the intended prodrug design and support once-weekly dosing. Following multiple doses of MBX 2109, there was a dose-related increase in mean albumin-adjusted serum calcium concentrations and dose-dependent suppression in endogenous PTH(1-84), consistent with the expected PTH pharmacology.
MBX Biosciences is preparing for an End-of-Phase 1 meeting with the U.S. Food and Drug Administration this quarter, and the company anticipates initiating its Phase 2 trial of MBX 2109 in patients with HP thereafter.
About Hypoparathyroidism
Hypoparathyroidism (HP) is a rare endocrine disorder caused by a deficiency of parathyroid hormone that results in decreased calcium and increased phosphorus levels in the blood. HP affects approximately 200,000 individuals worldwide, most of whom develop the condition following damage to or removal of the parathyroid glands during thyroid surgery. HP is associated with a wide range of symptoms such as paresthesias, muscle cramps, seizures, an impaired quality of life, and an increased risk of comorbidities including kidney stones and impaired renal function. The goal of treatment is to maintain blood calcium levels in the low-normal range while preventing symptoms of hypocalcemia. Current standard of care consists of high doses of calcium supplements and active vitamin D, which may contribute to the risk of renal disease and do not address the underlying pathophysiology caused by a lack of parathyroid hormone.
About MBX 2109
MBX 2109 is an investigational long-acting parathyroid hormone peptide prodrug in development as a PTH replacement therapy for hypoparathyroidism. It was designed with the company’s novel, proprietary Precision Endocrine Peptide™ (PEP™) platform technology to provide sustained PTH activity with a convenient once-weekly dosing regimen. In July 2022, MBX 2109 received orphan drug designation from the U.S. Food and Drug Administration for the treatment of hypoparathyroidism. MBX aims to simplify and improve an individual’s disease management, while relieving both the symptoms of the disorder and long-term complications.
About MBX Biosciences
MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide™ (PEP™) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives. MBX is advancing a pipeline of PEPs for clinically validated targets designed to deliver superior pharmaceutical properties and overcome key limitations of native peptide therapeutics. MBX’s pipeline includes its lead product candidate MBX 2109, which has completed Phase 1 development for the treatment of hypoparathyroidism, and MBX 1416, in Phase 1 development for the treatment of post-bariatric hypoglycemia. The company is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, Norwest Venture Partners, OrbiMed, RA Capital Management and Wellington Management. MBX is based in Carmel, Indiana. To learn more, please visit the company website at www.mbxbio.com and follow us on LinkedIn and X (formerly known as Twitter).
Media Contact:
Ian Stone
Evoke Canale
[email protected]
619-849-5388
Investor Contact:
Irina Koffler
LifeSci Advisors
917-734-7387
MBX Biosciences Announces Positive Phase 1 Multiple Ascending Dose Data for MBX 2109, a Long-Acting Parathyroid Hormone Peptide Prodrug, in Healthy Adults
MBX 2109 was observed to be generally well-tolerated
MBX 2109 increased albumin adjusted serum calcium and suppressed endogenous PTH(1-84)
CARMEL, Ind., September 11, 2023 — MBX Biosciences, Inc., a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced positive results from the multiple ascending dose (MAD) portion of the Phase 1 trial of MBX 2109, the company’s long-acting parathyroid hormone (PTH) peptide prodrug in development for the treatment of hypoparathyroidism (HP).
“We are pleased with the positive and encouraging data seen throughout our Phase 1 program which we believe provides initial validation of the potential benefits of our PEP platform technology,” said Kent Hawryluk, president and chief executive officer of MBX Biosciences. “We look forward to advancing MBX 2109, our lead product candidate and potentially best-in-class PTH replacement therapy, into the next stage of development as we prepare for our end of Phase 1 meeting with the FDA later this year. I would like to thank the study participants, study investigators, and our partners who contributed to this study in pursuing a treatment option for hypoparathyroidism, a rare endocrine disorder with significant unmet medical need worldwide.”
The randomized, double blind, placebo-controlled Phase 1 trial enrolled 76 adults and was designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of MBX 2109 in healthy adult volunteers who were administered MBX 2109 subcutaneously. The primary endpoint was safety and tolerability, and secondary endpoints included PK and PD parameters. Single and multiple ascending doses of MBX 2109 were observed to be generally well-tolerated. The PK parameters reflected the prodrug design and were supportive of once-weekly administration and PD effects were consistent with the expected PTH pharmacology, as compared to placebo. Increases in albumin adjusted serum calcium and concomitant suppression of PTH(1-84) were observed in study participants treated once weekly with subcutaneously administered MBX 2109 for four doses.
Full results of the study will be reported at an upcoming medical conference.
About Hypoparathyroidism
Hypoparathyroidism (HP) is a rare endocrine disorder caused by a deficiency of parathyroid hormone that results in decreased calcium and increased phosphorus levels in the blood. HP affects approximately 200,000 individuals worldwide, most of whom develop the condition following damage to or removal of the parathyroid glands during thyroid surgery. HP is associated with a wide range of symptoms such as paresthesias, muscle cramps, seizures, an impaired quality of life, and an increased risk of comorbidities including kidney stones and impaired renal function. The goal of treatment is to maintain blood calcium levels in the low-normal range while preventing symptoms of hypocalcemia. Current standard of care consists of high doses of calcium supplements and active vitamin D, which may contribute to the risk of renal disease and do not address the underlying pathophysiology caused by a lack of parathyroid hormone.
About MBX 2109
MBX 2109 is an investigational long-acting parathyroid hormone peptide prodrug in development as a PTH replacement therapy for hypoparathyroidism. It was designed with the company’s novel, proprietary Precision Endocrine Peptide™ (PEP™) platform technology to provide sustained PTH activity with a convenient once-weekly dosing regimen. In July 2022, MBX 2109 received Orphan Drug designation from the U.S. Food and Drug Administration for the treatment of hypoparathyroidism. MBX aims to simplify and improve an individual’s disease management, while relieving both the symptoms of the disorder and long-term complications.
About MBX Biosciences
MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide™ (PEP™) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives. MBX is advancing a pipeline of PEPs for clinically validated targets designed to deliver superior pharmaceutical properties and overcome key limitations of native peptide therapeutics. MBX’s pipeline includes its lead product candidate MBX 2109, completing Phase 1 development for the treatment of hypoparathyroidism, and MBX 1416, entering Phase 1 development for the treatment of post-bariatric hypoglycemia. The company is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, Norwest Venture Partners, OrbiMed, RA Capital Management and Wellington Management. MBX is based in Carmel, Indiana. To learn more, please visit the company website at www.mbxbio.com and follow us on LinkedIn and Twitter.
Media Contact:
Ian Stone
Evoke Canale
[email protected]
619-849-5388
Investor Contact:
Irina Koffler
LifeSci Advisors
917-734-7387
MBX Biosciences to Participate in Morgan Stanley Global Healthcare Conference
CARMEL, Ind., August 29, 2023 — MBX Biosciences, Inc., a clinical stage biopharmaceutical company developing Precision Endocrine Peptide™ (PEP™) therapeutics to treat an array of endocrine disorders, today announced that Kent Hawryluk, President and Chief Executive Officer, and Richard Bartram, Chief Financial Officer, will participate in a fireside chat at the Morgan Stanley Global Healthcare Conference on Tuesday, September 12th, 2023, at 11:30 a.m. Eastern Time and will host 1-on-1 investor meetings.
About MBX Biosciences
MBX Biosciences, Inc. is a clinical-stage biopharmaceutical company pioneering Precision Endocrine Peptide™ (PEP™) therapeutic candidates to help people with endocrine disorders live fuller and healthier lives. MBX is advancing a pipeline of PEPs for clinically validated targets designed to deliver superior pharmaceutical properties and overcome key limitations of native peptide therapeutics. MBX’s pipeline includes its lead product candidate MBX 2109, currently in Phase 1 development for the treatment of hypoparathyroidism (HP), and MBX 1416, entering Phase 1 development for the treatment of post-bariatric hypoglycemia (PBH). The company is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates, Norwest Venture Partners, OrbiMed, RA Capital Management and Wellington Management. MBX is based in Carmel, Indiana. To learn more, please visit the company website at www.mbxbio.com and follow us on LinkedIn and Twitter.
Media Contact:
Ian Stone
Evoke Canale
619-849-5388
Investor Contact:
Irina Koffler
LifeSci Advisors
917-734-7387