Achillion Pharmaceuticals Inc. says a key ingredient for treating chronic hepatitis C infections has passed initial testing, clearing way for the New Haven drug developer to move to a second phase of clinical trials for the compound.
President and CEO Michael Kishbauch announced Thursday a single dose of ACH-3102 compound given in August to 14 healthy volunteers showed its efficacy, with minimal side effects, in holding in check over a 14-day period a particularly virulent strain of the virus, known as genotype 1b hepatitis C – GT 1b HCV, for short.
Based on that “proof-of-concept’’ test, Achillion says it is launching a pilot Phase 2 clinical trial evaluating ACH-3102 in combination with ribavirin for the treatment of patients with chronic GT 1b HCV.
Such testing is mandatory before Achillion can formally apply to federal drug regulators for approval to market the drug.
Achillion’s business model is to create small-molecule drugs to treat a variety of bloodborne illnesses, including HIV.
Hepatitis C is the most prevalent form of blood-borne virus, infecting an estimated 150 million people worldwide – five million of them Americans.
Chronic hepatitis C inflames the liver, which can lead to cancer, liver failure or death.
