Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) stock has been in focus in response to its update of a sustained treatment advantage in subjects with chronic ITP getting fostamatinib in a long-term Phase III extension trial.
Responders from preliminary studies who registered in Study 049 have kept a median platelet count of 106,500/uL. In addition, 22% of subjects cured with fostamatinib for at least 12 weeks recorded a stable platelet response.
The buzz
Fostamatinib hinders an enzyme named spleen tyrosine kinase which plays a major role in certain autoimmune disorders and blood cancers. The firm plans to submit a marketing application in the United States this quarter. Raul Rodriguez, the CEO and President of Rigel, said that they now have more than 16 months of FIT Phase III data to assess and they are extremely inspired that chronic ITP subjects who respond to fostamatinib can maintain a median platelet number of more than 100,000 platelets/uL. This information continues to support their plan to file a New Drug Application to the U.S. FDA for fostamatinib in chronic ITP in 1Q2017.
In people with ITP, the immune arrangement attacks and abolishes the body’s blood platelets, which serve an active part in healing and blood clotting. Common indications of ITP are excessive bleeding and bruising. Patients with chronic ITP face increased risk of major bleeding events that can lead in serious medical issues, or even death.
Existing treatments for ITP comprise blood platelet production boosters, splenectomy and steroids. However, a big part of patients does not response well on current treatments. As a result, there is a considerable medical need for improved treatment alternatives for patients with ITP.
Fostamatinib can be stated as an oral investigational product candidate with an innovative mechanism of action intended to restrict SYK kinase, a major player in the immune procedure that leads to platelet damage in ITP.
