- MBX Biosciences announced **positive top-line results** from its AVAIL Phase II trial for once-weekly candiparatide, a treatment for hypoparathyroidism, with **63% of patients** achieving the primary composite endpoint at week 12 compared to **31% on placebo**.  **[1776111_2152469_1]** 
- In the ongoing open-label extension study, overall responder rates increased to **79% at six months**, with **90% of patients** gaining independence from active vitamin D and **81%** from therapeutic doses of oral calcium.  **[1776111_2152469_1]** **[1776111_2152469_5]** 
- Once-weekly candiparatide was **well tolerated** in the 12-week trial, with no treatment-related serious adverse events or discontinuations.  **[1776111_2152469_1]** **[1776111_2152469_6]**  The most commonly reported adverse events included headaches, hypercalcemia, arthralgia, and nausea.  **[1776111_2152469_6]** 
- The company plans to advance candiparatide into **Phase III development** in **2026**, following an end-of-Phase II meeting with the FDA.  **[1776111_2152469_1]** **[1776111_2152469_7]**

MBX Biosciences Reports Positive Phase II Results for Once-Weekly Candiparatide

- MBX Biosciences announced that its once-weekly canvuparatide achieved the primary endpoint in its Phase 2 Avail™ trial for chronic hypoparathyroidism, demonstrating a **63% responder rate at 12 weeks**.  **[1776111_0001193125-25-210049_mbx-ex99_1.htm:0]** **[1776111_0001193125-25-210049_mbx-20250922.htm:1]** 
- The responder rate further improved to **79% at 6 months** in the open-label extension (OLE).  **[1776111_0001193125-25-210049_mbx-ex99_1.htm:0]** **[1776111_0001193125-25-210049_mbx-20250922.htm:1]** 
- The therapy was generally well tolerated, with **no treatment-related serious adverse events or discontinuations** reported during the 12-week trial.  **[1776111_0001193125-25-210049_mbx-ex99_1.htm:0]** **[1776111_0001193125-25-210049_mbx-20250922.htm:1]** 
- Based on these positive results, MBX Biosciences plans to initiate a **Phase 3 clinical trial in 2026**.  **[1776111_0001193125-25-210049_mbx-ex99_1.htm:0]** **[1776111_0001193125-25-210049_mbx-20250922.htm:1]**

MBX Biosciences (MBX)