Our Pipeline

At MBX, we are reimagining how patients live with endocrine diseases.

Enabled by our proprietary PEPTM platform technology, we have a growing pipeline of therapeutic candidates in various stages of clinical development.

“Our pipeline of PEP candidates includes clinically validated targets with well-defined regulatory pathways to address significant unmet medical needs. Our efforts will make a meaningful impact in improving the lives of individuals with endocrine disorders.”

steven j. prestrelski, PHD
Chief Scientific Officer

Development Programs

IND Enabling
Phase 1
Phase 2
Phase 3
MBX 2109
MBX 2109
Once-Weekly PTH Replacement Therapy for Hypoparathyroidism

MBX 2109 is an investigational new drug (delivered via sub-cutaneous injection), designed to offer a precision-based approach to help people with hypoparathyroidism achieve continuous and consistent exposure to parathyroid hormone (PTH). Under physiological conditions, MBX 2109 is a prodrug, engineered to be biologically inactive at the time of administration, but chemically converts to an active PTH peptide following administration. MBX 2109 delivers consistent and optimal PTH peptide levels with the convenience of once-weekly dosing. This results in binding the PTH receptor which increases calcium levels in the blood. The outcome is restoration of normal PTH physiology, correcting mineral imbalances, and alleviating the symptoms of the disorder.

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

1. Clarke B. et al. JCEM 2016
2. Powers J. et al. JBMR 2013
3. Shishiba Y. et al. J of Japan Endo Society and Thyroid Surgery 2017.
4. David K. et al. European J of Endocrinology. 2019; 180:71-78.
5. Underbjerg L et al, JBMR 2014;29(11):2504-2510.
6. Mitchel DM et al. JCEM. 2012;97(12):45074514.
7. Underbjerg L et al JBMR 2013; 28(11): 2277-2285
9. Hadker N et al. Endocrine Practice. 2014; 20:671-679.
MBX 1416
Hypoglycemia (PBH)
MBX 1416
A potential treatment for post-bariatric hypoglycemia (PBH)

MBX 1416 is an investigational therapy in development as a potential treatment for post-bariatric hypoglycemia (PBH). We aim to prevent the occurrence of severe hypoglycemia (very low blood sugar) in individuals with PBH so they can lead healthier lives. MBX 1416 is currently in Phase 1 clinical studies.

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.

1. Salehi M et al. JCEM 2018; 103: 2815-2826.
Additional Candidates
Additional Candidates
Novel therapies for rare disease and beyond

Our world-class technology platform was developed with the flexibility to tackle a variety of diseases that could benefit from more precise therapeutic options. We have an active research and design program, through which we have identified numerous additional candidates in both rare and prevalent diseases. These candidates are in various stages of clinical development.

From Pipeline to Promise

World-Class Peptide Platform

Explore what patients have to say and learn more about current clinical trials and how MBX Biosciences is striving to make a difference for people living with hypoparathyroidism and post-bariatric hypoglycemia.