MBX Biosciences, Inc. (NASDAQ:MBX) stock traded higher on Monday after the company released clinically meaningful and statistically significant topline results from the once-weekly canvuparatide Phase 2 trial..
On Monday, the company announced that once-weekly canvuparatide achieved the primary endpoint with statistical significance at Week 12 in its Phase 2 Avail trial.
The trial demonstrated positive 6-month results from the open-label extension (OLE) in adult patients with chronic hypoparathyroidism.
All patients (n=64) completed the 12-week study, and 94% of patients elected to enroll in the OLE.
In the 12-week randomized portion of the trial, 63% of canvuparatide-treated patients met the prespecified primary composite endpoint with zero contribution from PRN rescue therapy compared with 31% in placebo-treated patients.
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In the OLE, 79% of patients receiving once-weekly canvuparatide achieved responder status at 6 months.
Responders were defined as patients who maintained serum calcium levels in the normal range (8.2–10.6 mg/dL) and independence from conventional therapy.
MBX is preparing to initiate a Phase 3 clinical trial of once-weekly canvuparatide in 2026.
Select Secondary and Exploratory Endpoints
Pharmacokinetic (PK) findings were consistent with the Phase 1 results, supporting a once-weekly dosing schedule.
Bone turnover and formation markers increased over 12 weeks compared to placebo, consistent with enhanced bone remodeling.
In patients with elevated urine calcium at screening that normalized at Week 12, mean urine calcium was reduced by 48% in patients treated with once-weekly canvuparatide compared with 33% on placebo.
All doses of canvuparatide were generally well-tolerated, with no discontinuations related to canvuparatide.
Most treatment-emergent adverse events were categorized as mild or moderate. No deaths were reported.
MBX Price Action: MBX Biosciences shares were up 98.60% at $19.86 during premarket trading on Monday. The stock is trading within its 52-week range of $4.80 to $27.50, according to Benzinga Pro data.
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