SGTX - FDA places clinical hold on Sigilon Therapeutics' early-stage SIG-001 hemophilia trial

The U.S. FDA has placed a clinical hold on Sigilon Therapeutics' (SGTX) Phase 1/2 study of SIG-001 in patients with severe or moderately severe hemophilia A.The clinical hold was initiated following the company’s submission of a serious adverse event ((SAE)) and temporary enrollment halt to the FDA and other regulatory agencies.One patient, who received the highest dose of study drug, developed inhibitors to Factor VIII ((FVIII)) — a well-known complication of FVIII therapy, the company said. Among other things, the FDA has requested additional information or data on factors potentially contributing to the development of inhibitors in this patient, such as family history and immune stimulation from a recent vaccination."In collaboration with the regulatory agencies and our advisors, we are conducting a thorough investigation of this event to confirm whether there was a causal relationship between the development of inhibitors and SIG-001," CEO Rogerio Vivaldi said.

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FDA places clinical hold on Sigilon Therapeutics' early-stage SIG-001 hemophilia trial