Cytokine Initiates Phase I Study Of CPSI-2364

Cytokine has initiated the phase I study of CPSI-2364, its orally active, smallmolecule inhibitor of the production of TNF-alpha and other pro-inflammatory cytokines.

CPSI-2364 is a chemically-modified form of the synthetic guanylhydrozone, semapimod. An intravenous formulation of semapimod was shown to have significant anti-inflammatory activity in phase II clinical trials in Crohn’s disease, psoriasis and ERCP-induced pancreatitis.

However, that formulation caused doselimiting local reactions, such as phlebitis. To overcome this problem, the company developed CPSI-2364, a more soluble salt of semapimod that makes oral dosing possible. Animal models have confirmed the oral activity of CPSI-2364, said the company.

Dennis Willson, president and CEO of Cytokine, said: “Based on extensive work with the predecessor compound, we believe CPSI-2364 has the potential to revolutionize the treatment of TNF-mediated diseases, such as Crohn’s, rheumatoid arthritis and psoriasis. We are excited to be advancing it into the clinic.”

“As a small molecule, CPSI-2364 is less expensive to produce than biologics and can be given orally. Moreover, because it is not a protein, CPSI-2364 is not expected to generate antibodies that could neutralize its activity and result in loss of efficacy over time,” he added.