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Achillion Launches HIV/AIDS Clinical Development Program
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Business New Haven
8/19/2002
By: Melissa Nicefaro
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NEW HAVEN - Achillion Pharmaceuticals has announced receipt of regulatory clearance and the commencement of a Phase 2 clinical study with company's lead product candidate, ACH-126,443 (Beta-L-Fd4C), in patients with HIV/AIDS. The study is being conducted under Achillion's second Investigational New Drug Application (IND) cleared by the U.S. Food & Drug Administration (FDA), allowing the company to conduct clinical development in a second therapeutic indication.
“This second IND in two years expands our clinical development activities from chronic hepatitis B infection into the therapeutic area of HIV,” explained Achillion CEO William G. Rice. “It also reflects our commitment to bring new medicines rapidly onto the market to treat patients having drug resistant forms of infectious diseases.”
This study will assess suppression of viral replication by ACH-126,443 in patients with HIV infection. The patients to be enrolled in this double-blind study will maintain their combination therapy and will be randomized to continue lamivudine or to replace it with ACH-126,443, administered daily. The study will be conducted in multiple North American centers.
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