{"id":888188,"date":"2025-09-22T07:06:24","date_gmt":"2025-09-22T11:06:24","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/mbx-biosciences-announces-once-weekly-canvuparatide-achieved-primary-endpoint-in-phase-2-trial-with-63-responder-rate-at-12-weeks-79-responder-rate-at-6-months-in-open-label-extension\/"},"modified":"2025-09-22T07:06:24","modified_gmt":"2025-09-22T11:06:24","slug":"mbx-biosciences-announces-once-weekly-canvuparatide-achieved-primary-endpoint-in-phase-2-trial-with-63-responder-rate-at-12-weeks-79-responder-rate-at-6-months-in-open-label-extension","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/mbx-biosciences-announces-once-weekly-canvuparatide-achieved-primary-endpoint-in-phase-2-trial-with-63-responder-rate-at-12-weeks-79-responder-rate-at-6-months-in-open-label-extension\/","title":{"rendered":"MBX Biosciences Announces Once-Weekly Canvuparatide Achieved Primary Endpoint in Phase 2 Trial with 63% Responder Rate at 12 Weeks; 79% Responder Rate at 6 Months in Open-Label Extension"},"content":{"rendered":"
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\n Statistically significant responder rate achieved at 12 weeks with zero contribution from rescue therapy (PRN) and further improvement sustained in open-label extension (OLE)<\/em>\n <\/p>\n

\n Positive findings in bone and kidney biomarkers<\/em>\n <\/p>\n

\n All patients completed the 12-week Avail<\/em>
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\n TM<\/em>
\n <\/sup>
\n trial and 94% entered the OLE<\/em>\n <\/p>\n

\n Once-weekly canvuparatide was generally well tolerated, with no treatment-related serious adverse events or discontinuations during the 12-week trial<\/em>\n <\/p>\n

\n Preparation underway to initiate Phase 3 trial in 2026<\/em>\n <\/p>\n

\n Company to host conference call at 8:00 am ET today<\/em>\n <\/p>\n

CARMEL, Ind., Sept. 22, 2025 (GLOBE NEWSWIRE) — MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced once-weekly canvuparatide achieved the primary endpoint with statistical significance at Week 12 in its Phase 2 Avail\u2122 trial, and demonstrated positive 6-month results from the OLE, in adult patients with chronic hypoparathyroidism (HP). All patients (n=64) completed the 12-week study, and 94% of patients elected to enroll in the OLE.<\/p>\n

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. 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\u201310.6 mg\/dL) and independence from conventional therapy (active vitamin D and >600 mg\/day of calcium supplements).<\/p>\n

Based on these positive results, MBX is preparing to initiate a Phase 3 clinical trial of once-weekly canvuparatide in 2026.<\/p>\n

\u201cThe results from the Avail trial are encouraging. A once-weekly therapy could simplify administration and help address important unmet medical needs of patients with hypoparathyroidism,\u201d said Mishaela Rubin, MD, MS, Professor of Medicine at Columbia University Vagelos College of Physicians and Surgeons and an investigator in the Avail clinical trial. \u201cHypoparathyroidism poses a substantial burden to patients, who often face complex treatment regimens and unpredictable swings in calcium levels that can lead to serious complications. The 12-week and 6-month data provide promising early evidence that this investigational therapy may offer a potential option for long-term management, pending further study.\u201d<\/p>\n

\u201cWe are very pleased with the clinically meaningful and statistically significant topline results from our once-weekly canvuparatide Phase 2 trial. These data reinforce our conviction that canvuparatide could become a potential best-in-class treatment for hypoparathyroidism and demonstrate the value of our novel Precision Endocrine Peptide platform technology,\u201d said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. \u201cWe believe the totality of the data support a once-weekly product profile with continuous infusion-like PTH exposure. These 12-week and 6-month results represent the potential for a meaningful improvement over current treatment options for HP patients and provide a strong foundation for further development. We look forward to sharing additional once-weekly canvuparatide clinical data at an upcoming medical meeting as we prepare for initiation of our Phase 3 trial.\u201d<\/p>\n

\n Phase 2 Avail Topline Results <\/strong>\n <\/p>\n

\n 12-week and 6-month Responder Rates: <\/u>\n <\/p>\n