MBX Biosciences To Report Phase 2 Data For Potential Once-Weekly Hypoparathyroidism Drug

(RTTNews) - MBX Biosciences Inc. (MBX), a clinical-stage biopharmaceutical company, is scheduled to report topline results from its Avail trial today.

Avail is a phase 2 study evaluating the safety, pharmacokinetics, and efficacy of the company's potential once-weekly investigational drug Canvuparatide for chronic hypoparathyroidism. The study is fully enrolled with 64 patients instead of the initial target of 48.

Hypoparathyroidism is a rare endocrine disease caused by a deficiency of parathyroid hormones that results in decreased calcium levels in the blood, leading to hypocalcemia. Hypocalcemia can result in a variety of acute symptoms, such as muscle cramping or spasm, tingling, and neurological symptoms such as depression, confusion, and cognitive impairment.

Canvuparatide, also referred to as MBX 2109, is a parathyroid hormone peptide prodrug that is designed as a potential long-acting hormone replacement therapy for the treatment of patients with chronic hypoparathyroidism. The drug candidate also carries the FDA's orphan drug designation tag for the treatment of hypoparathyroidism.

The primary endpoint of the phase 2 clinical trial is to measure the ratio of patients who can stop active vitamin D and reduce calcium supplements to less than or equal to 600 mg per day after 12 weeks of treatment while maintaining normal serum albumin-adjusted calcium levels in the range of 8.2-10.6 mg/dL. Albumin-adjusted calcium level — also known as corrected calcium gives the true calcium status of the body, especially when albumin, which binds the calcium in blood, is not normal.

The global hypoparathyroidism treatment market is projected to reach $1.32 billion by 2032, growing at a compound annual growth rate of 7.7%, according to market analysis.

For the treatment of hypoparathyroidism in adults, the FDA has earlier approved Yorvipath of Ascendis Pharma, as the first once-daily drug specifically for the treatment of hypoparathyroidism in adults.

If approved, Canvuparatide's once-a-week dosing may be more convenient if it works comparably to the earlier approved drug.

The company will be holding a conference call and a webcast at 8 am ET on Monday, September 22, to discuss the results from the trial.

MBX closed Friday's (Sep.19, 2025) trading at $10.00, down 0.70%.