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MBX Biosciences Announces One-Year Data Demonstrating Sustained Benefit of Once-Weekly Canvuparatide as a Potential PTH Replacement Therapy in Chronic Hypoparathyroidism
Responder rate of 57% at one year in open-label extension (OLE) comparable to 63% at 12 weeks in Phase 2 Avail™ trial Results consistent with restoration of systemic PTH activity through serum calcium normalization, reduction of urine calcium excretion, restoration of bone metabolism and increase of eGFR (a measure of kidney function) High retention rate with 90% of patients entering the OLE remaining in the study at one year Canvuparatide was generally well tolerated with no new safety signals
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Responder rate of 57% at one year in open-label extension (OLE) comparable to 63% at 12 weeks in Phase 2 Avail™ trial Results consistent with restoration of systemic PTH activity through serum calcium normalization, reduction of urine calcium excretion, restoration of bone metabolism and increase of eGFR (a measure of kidney function) High retention rate with 90% of patients entering the OLE remaining in the study at one year Canvuparatide was generally well tolerated with no new safety signals during the OLE PK supports once-weekly dosing, with low peak-to-trough ratio and stable exposure Phase 3 pivotal trial remains on track to initiate in Q3 2026 Company to host conference call today at 8:00 a.m. ET CARMEL, Ind. and BURLINGTON, Mass., June 12, 2026 (GLOBE NEWSWIRE) -- MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced full results from the 12-week Avail™ Phase 2 trial and new one-year data from the ongoing open-label extension (OLE) study of once-weekly canvuparatide in adult patients with chronic hypoparathyroidism. “These results continue to support the potential of once-weekly canvuparatide to address important unmet needs for patients with hypoparathyroidism,” said Michael T. Collins, M.D. Endocrinologist, Special Volunteer and Senior Clinical Advisor at the National Institutes of Health. “The maintenance of calcium homeostasis, increased eGFR, decreased urine calcium and bone remodeling observed through one year are encouraging and consistent with the physiologic effects of restored PTH action. A therapy that can provide sustained control of multiple disease markers with once-weekly administration could represent a meaningful advance for patients and supports moving into Phase 3 study for canvuparatide.” “The full Phase 2 and one-year OLE results underscore the potential for once-weekly canvuparatide to become a best-in-class treatment option for patients with chronic hypoparathyroidism,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “The totality of the clinical data we announced today – including the impact of canvuparatide on calcium, kidney function and bone – support a convenient once-weekly approach to physiol...
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