Despite early signals of efficacy, the Phase II studies Cytokine PharmaSciences (CPSI) conducted in Crohn’s disease were dose-limited by local reactions (i.e., phlebitis) to the semapimod-HCl formulation. These reactions led to the need to develop a less irritating intravenous (IV) form. In response, CPSI has developed a new salt form of semapimod with a dramatically improved solubility and tolerability profile, which ultimately resulted in the new orally available formulation.
The new salts have demonstrated their ability to reduce cytokine levels when given orally in a preclinical sepsis model. The company is ready to move these new salts into clinical trials and is seeking a partner to assist with their development plan.
Dr Thais Sielecki, director of research at CPSI, said: “The ability to dose orally is viewed as a considerable advance in the development of semapimod. As a synthetic small-molecule, semapimod holds the promise of a more cost-effective alternative to expensive and difficult-to-manufacture biologics. Oral dosing would also make treatment much easier than the IV and subcutaneous routes, which are currently the only options for many patients.”