Our Pipeline

We have successfully completed Phase 1 trials and are looking to advance to Phase 2 clinical trials in the first half of 2024.

Parathyroid hormone (PTH) is a peptide hormone secreted by the parathyroid glands that regulates calcium and phosphate levels in the blood through its effects on bone, kidneys and intestines. The parathyroid glands are located behind the thyroid gland in the neck.

Hypoparathyroidism (HP) is a rare condition in which the parathyroid glands fail to produce sufficient amounts of PTH. It affects more than 260,000 persons throughout the United States, Europe and Japan.1-3 HP is often caused by damage to or removal of the parathyroid glands during surgery for another condition but it can be caused by an autoimmune process or other etiologies. Insufficient PTH results in a lowering of blood calcium levels (hypocalcemia) and an increase in phosphate levels (hyperphosphatemia).

Hypocalcemia can cause a variety of symptoms ranging in intensity from mild to severe, including muscle cramps and spasms in the hands and feet and numbness or tingling around the mouth and fingers and toes.4 Depression, confusion and loss of memory have been reported5 and certain individuals may develop calcium deposits in the brain or the kidneys, which can lead to impairment of kidney function.4,6,7 Persons with HP may also be more prone to developing kidney stones.4,7 Less often, more serious complications can occur including seizures or cardiac arrhythmias (abnormal heartbeat).7,8 Consequently, HP can greatly impact a person’s quality of life, interfere with their daily lives, and negatively impact their ability to work.9

Treatment of HP is aimed at raising calcium levels in the blood to provide relief of symptoms without causing abnormally high levels of calcium in the blood (hypercalcemia) or urine (hypercalciuria). The mainstay of treatment is calcium supplements and active vitamin D. Long-term use of these can contribute to the development of calcium deposits and kidney stones.

Post-bariatric hypoglycemia (PBH; low blood sugar) is rare but increasingly recognized complication of bariatric surgery, occurring after both Roux-en-Y gastric bypass and vertical sleeve gastrectomy. Most patients present within 1 to 4 years of surgery.1

Hypoglycemia (low blood glucose) can occur 1-3 hours after ingestion of a carbohydrate-rich meal. In some individuals, neuroglycopenic symptoms may develop, which can include confusion, weakness, dizziness, blurred vision and loss of consciousness or seizure. These symptoms can result in trauma to the individual. Often individuals experiencing neuroglycopenic symptoms are refractory to conservative therapy with dietary changes. Medications such as acarbose, diazoxide or octreotide may be used off-label by doctors, but poor tolerability limits their use, and none are approved to treat PBH. There remains a significant unmet need to develop therapies to address this condition.

Screening for obesity is performed by healthcare providers using body mass index (BMI), which measures the percent of body fat in an individual. A person whose weight is higher than what is considered to be a normal weight for a given height is described as being overweight or having obesity.2 In the case of adults 20 and older, a BMI >30 is classified as obese and >40 is severely obese.

A high percentage of body fat can put an individual’s health at risk as it increases the likelihood for developing more than 200 health problems such as high blood pressure, type 2 diabetes, depression, cancer and heart disease – the leading cause of death in the United States. In fact, research shows that there has been a three-fold increase in obesity-related deaths from heart disease in the United States between 1999-2020.3

The biomedical, psychosocial, and economic consequences of obesity have substantial implications for the health and well-being of the U.S. population.4 There is also a bias to be addressed, as it is well documented that those who feel stigmatized by obesity can suffer extreme emotional distress and be subject to discrimination, which can lead to further negative health impacts, including depression and additional weight gain.5

While lifestyle changes may influence weight loss and reductions in BMI, obesity is a complex problem that often does not have a single solution. Whether behavioral, pharmacologic, or surgical, this epidemic may benefit from a holistic multifaceted approach.6