Coley Seeks HCV Partner For Actilon
This article was originally published in The Pink Sheet Daily
Executive Summary
Firm suspends independent development of the hepatitis C agent in hopes of finding a partner with resources and expertise to share the risk.
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Coley Pharmaceutical Group is seeking a development partner with financial resources or hepatitis C experience to study its HCV candidate Actilon in treatment-naive patients. The company announced a decision to suspend independent development of the drug Jan. 22 following lackluster clinical trial results in treatment-experienced patients. "Our assessment of drug development in the naive setting is that this landscape is complex, rapidly changing and risky," CEO Robert Bratzler stated during a conference call Jan. 23. "Therefore, we believe it is fiscally prudent to suspend our independent development of Actilon until we secure a partner or until the development path for second generation immunomodulating agents such as Actilon becomes clear." The company had been pursuing development of the drug in treatment-experienced patients as part of a strategy aimed at getting the drug to market faster. However, the company announced Phase II clinical trial results in November showing no meaningful differences in viral load reduction among null and partial responder treatment-refractory patients treated with Actilon in combination with pegylated interferon and ribavirin after 48 weeks. "To be clear, we do not believe the full potential of Actilon in hepatitis C has been evaluated," the exec said. "We have not assessed Actilon's safety and activity in the naive population, either as an interferon replacement or in combination with standard of care." In addition, the drug may have utility in other infectious disease areas, he said. In the meantime, Coley will focus its resources towards discovering and developing new TLR Therapeutics , including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate toll-like receptors 7 and 8, and its other synthetic agonists and antagonists targeting TLR 7, 8 and 9, the firm reported. As a result, the Wellesley, Mass. company will reduce its workforce - primarily in drug development - by 20% and focus on outsourcing future drug development activities. Following the cuts, the company will have approximately 125 employees. The estimated termination charges associated with the eliminations will be roughly $1.1 mil. Coley has a TLR 9 agonist called ProMune in Phase III development with Pfizer. The candidate is being studied for the treatment of solid tumors, including breast cancer and non-small cell lung cancer (1 (Also see "Pfizer/Coley Prep Phase III Study Of ProMune For First-Line Lung Cancer" - Pink Sheet, 23 May, 2005.)). The drug has been highlighted by Pfizer in discussions about its pipeline, most recently during the company's analyst meeting Jan. 22 announcing a new R&D structure, when Pfizer R&D President John LaMattina mentioned it as one of several compounds the team is "excited about." He also mentioned that the drug's name, ProMune, is likely to be changed going forward. Coley's Bratzler said Pfizer's commitment to the drug remains high following its restructuring announcement. "We are one of four, maybe five, Phase III programs in Pfizer's pipeline. I think that speaks volumes about where Pfizer might want to put their resources going forward," he said. -Jessica Merrill ([email protected]) |