Sigilon Therapeutics Inc. (NASDAQ: SGTX) stock declined by 29.27% in the current market trading session. Sigilon Therapeutics’ Shielded Living Therapeutics system aims to create functional treatments for chronic illnesses. Patients with chronic illnesses such as hemophilia, lysosomal diseases, and diabetes can benefit from Sigilon’s product candidates, which are non-viral engineered cell-based treatments that generate critical proteins, enzymes, or factors.
What is happening?
The US Food and Drug Administration has put Sigilon Therapeutics’ Phase 1/2 trial of SIG-001 in patients with chronic or moderately severe hemophilia A on clinical hold, according to SGTX. Following SGTX’s submission of a severe adverse event (SAE) and temporary enrollment suspension to the FDA and other regulatory bodies, the trial hold was implemented.
SIG-001 has been given to three patients thus far. The third patient, who got the highest dose of the trial medication, developed Factor VIII (FVIII) inhibitors, which is a well-known side effect of FVIII treatment. The patient’s condition is improving and he is responding well to medical therapy. The FDA has asked for more information or data on variables that may have contributed to the development of inhibitors in this patient, such as family history and immunological activation from a recent vaccine, among other things. While the firm examines the SAE, all three patients involved in this trial will be monitored as per study protocol.
Rogerio Vivaldi, President and CEO of Sigilon stated,
SGTX’s main focus is patient safety, and they’re glad to hear that the patient is doing well. They are conducting a comprehensive examination of this occurrence in conjunction with regulatory bodies and their advisers to ascertain if there was a causal link between the emergence of inhibitors and SIG-001. They want to engage with the FDA to get the clinical hold lifted.
The Safety Monitor Committee will continue to review the status of the SAE investigation for SIG-001, and Sigilon will offer more information as it becomes available.