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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.

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