Successful GMP Manufacture Advances Ox-1 to Clinic

Summary by AI BETAClose X

TheraCryf plc has successfully manufactured over 2kg of its lead asset, Ox-1 receptor antagonist, to Good Manufacturing Practice (GMP) standard, producing 2.57kg of human-grade material three weeks ahead of schedule. This achievement, which confirms the scalability and robustness of their optimized manufacturing process, enables the company to advance towards Phase 1 clinical trials without program delays. The successful GMP manufacture further de-risks the program, which targets the substantial substance use disorder market projected to exceed $70 billion by 2035, and supports the planned Q3 2026 completion of the preclinical package for regulatory submission.

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