Sigilon Therapeutics Inc (NASDAQ: SGTX), a biotechnology firm that develops functional cures for chronic diseases via its Shielded Living Therapeutics, has recently placed its clinical study on hold for one of its drugs under development.
Notification from the U.S FDA: The company recently announced that the U.S FDA (Food and Drug Administration) notified Sigilon’s phase 1 / 2 study of SIG-OO1, which was conducted on patients with severe or moderately severe hemophilia A, has been put on a halt. The study has been put on halt due to serious adverse events and other regulatory requirements. While the company investigates the adverse events, all the three patients undertaken for the study will continue to follow the trial protocol. The third patient, who received the higher dose compared to the other two, was witnessed the development of inhibitors FVIII (Factor VIII). The patient has been given specific medication and responding well with the medical treatment, and their health continues to improve. The FDA has asked for specific other data or analysis of the factors contributing to the development of inhibitors in the patient under observation. The trial has also been temporarily halted by the Food and Drug Administration and other regulatory agencies.
Severe Adverse Event investigation to be review: The company stated the patient and their health is the top priority of the company or, for that matter, any other pharmaceutical company developing any drugs. The company has undertaken various observation practices in collaboration with the regulators to determine a relationship between the development of inhibitors and SIG-OO1. The company is constantly working with the FDA to resolve the trial placed on hold. The company further stated that the event (Sever adverse event) investigation would be constantly reviewed by the committee (safety review committee) for SIG-OO1. The company will try to provide as much information and data as and when available.