BridgeBio Pharma Stops Development Of BBP-631 For Congenital Adrenal Hyperplasia

(RTTNews) - BridgeBio Pharma Inc. (BBIO) said that it will no longer be pursuing development of BBP-631 for Congenital Adrenal Hyperplasia. The company is actively seeking partnership opportunities to support future development of BBP-631 or next-generation gene therapies for the treatment of Congenital Adrenal Hyperplasia, a very prevalent genetic disease that still has significant unmet need, with more than 75,000 cases estimated in the United States and European Union.

The company announced results from the Phase 1/2 open-label ADventure study investigating BBP-631, the Company's investigational adeno-associated virus (AAV) 5 gene therapy, for the treatment of congenital adrenal hyperplasia or CAH.

The company noted that the trial did not meet the threshold to warrant additional capital investment at this time, it will be reducing the gene therapy budget more than $50 million.

The key results from the study included increased endogenous cortisol production was achieved in all patients at higher doses. BBP-631 has been well tolerated with only mild to moderate treatment-emergent adverse events (TEAEs) and no treatment-related serious adverse events reported.

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