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news.Cytokine PharmaSciences's oral semapimod, a synthetic anti-cytokine compound, has been found to have potential in the treatment of inflammatory and autoimmune diseases including rheumatoid arthritis, Crohn's and psoriasis. The compound has previously been tested in clinical trials only as an intravenous infusion and the newly developed oral form should enhance its acceptability to patients and physicians.
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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.”