Hypoparathyroidism treatment MBX 2109 trial enrolled
Phase 2 trial will study 64 patients with chronic condition
A Phase 2 clinical trial testing MBX 2109 in people with chronic hypoparathyroidism has finished enrolling participants, according to MBX Biosciences, the treatment’s developer and sponsor of the trial.
“Completion of enrollment in our Phase 2 trial in [hypoparathyroidism] marks a significant milestone for MBX and brings us closer to our goal of delivering a long-acting [parathyroid hormone] therapy designed to treat the underlying disease [processes],” Kent Hawryluk, president and CEO of MBX, said in a company press release.
The Phase 2 trial, Avail (NCT06465108), enrolled 64 adults with chronic hypoparathyroidism who have been taking supplements of active vitamin D and at least 800 mg per day of calcium to manage their condition. The trial was originally designed to enroll 48 participants, but it exceeded its enrollment goal.
Participants will be randomly assigned to receive MBX2109 at one of three doses (400, 600, or 800 micrograms) or a placebo, given by injection under the skin once weekly for about three months.
Hypoparathyroidism treatment seen providing consistent, convenient therapy
The study’s main goal is to see how many participants are able to stop taking active vitamin D and reduce their daily calcium doses to 600 mg per day or lower while still maintaining blood calcium levels within normal ranges. The study also will evaluate MBX 2109’s safety profile and pharmacological properties, as well as the therapy’s impact on patient-reported quality of life.
Top-line results from the trial are expected in the third quarter.
Hypoparathyroidism is marked by abnormally low levels of parathyroid hormone (PTH), a hormone that helps to regulate levels of calcium and phosphorus in the blood. The active ingredient in MBX 2109, canvuparatide, is a prodrug of PTH, meaning it is an inactive molecule that gets converted to active PTH once inside the body.
Data from a Phase 1 study (NCT05158335) in healthy volunteers indicated that the therapy is long acting and effectively supplies the body with PTH that is missing in hypoparathyroidism.
“We believe canvuparatide could transform the [hypoparathyroidism] treatment landscape, potentially providing a more consistent therapeutic effect, while offering improved patient convenience and minimizing symptoms associated with large fluctuations in calcium,” Hawryluk said.
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