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HCV Protease Inhibitors: Vertex VX-950 clinical trial in 2003
  At the large annual hepatitis/liver conference AASLD which was held in November in Boston the first study results in HCV-infected patients using an HCV protease inhibitor were presented by Boerhinger-Ingleheim researchers. They reported encouraging results after patients received the protease inhibitor BILN-2061. Here is a link to NATAP's AASLD conference reports where you'll find 3 articles on the 2 studies conducted: http://www.natap.org/2002/AASLD/ndxAASLD.htm
Below is a press release from Vertex Pharma where they announce that they look forward to starting a study with their protease inhibitor in humans.
Vertex Pharmaceuticals Restructures Agreement with Eli Lilly; Vertex to Lead Development of Novel Oral Hepatitis C Protease Inhibitor VX-950
Thursday January 2, 4:05 pm ET -- VX-950 to Enter Clinical Trials in 2003 --CAMBRIDGE, Mass., Jan. 2 /CNW/ -- Vertex Pharmaceuticals Incorporated announced today that it has restructured its agreement with Eli Lilly and that Vertex will lead development and commercialization of VX-950, a novel, oral hepatitis C viral protease inhibitor. Vertex plans to begin clinical testing of VX-950 in the second half of 2003. Preclinical studies of VX-950, begun in early 2002, are continuing in preparation for the commencement of Phase I clinical trials. VX-950 is a small molecule protease inhibitor from a new class of antiviral drugs that inhibit hepatitis C NS3-4A protease, an enzyme considered essential for HCV viral replication.
The mutual decision to restructure the agreement is a result of a reprioritization of Eli Lilly's research portfolio and Vertex's desire to focus on specialty pharmaceutical markets and retain greater downstream rights to its own compounds. In order to reflect these strategic priorities, the companies have restructured their agreement. Vertex has obtained the worldwide rights to compounds identified during the collaboration. Eli Lilly will retain a financial interest in VX-950 and other HCV protease compounds through royalties on future net product sales. Financial terms were not disclosed."Vertex is enthusiastic about the opportunity to drive forward development and commercialization of this innovative compound. Obtaining worldwide rights to our HCV protease inhibitor program is an important value creation step and strengthens our antiviral and infectious disease portfolio. Our clinical group is well-positioned to move VX-950 into the clinic and capitalize on the value of our HCV protease inhibitor discovery program," said Joshua Boger, Ph.D., Chairman and CEO of Vertex."Drugs such as VX-950 could usher in a significant treatment advance and provide a medical breakthrough for patients with HCV," said John Alam, M.D., Vertex's Senior Vice President, Drug Evaluation and Approval. "Recent clinical data from studies with another company's HCV protease inhibitor compound have established initial proof-of-concept for small molecule HCV protease inhibitors. VX-950 is a distinct compound that has shown excellent in vitro potency, and high levels of drug were achieved in both plasma and liver in animal studies. We look forward to initiating clinical evaluation of VX-950 and to beginning to publish key data on Vertex's HCV protease compounds in the second half of 2003. In addition, we also anticipate that Vertex's ongoing HCV protease inhibitor discovery program will produce an additional drug candidate in 2003 suitable for clinical development."Background on VX-950Vertex researchers solved the three-dimensional atomic structure of HCV protease and reported the results in the journal Cell in 1996. In 1997, Vertex began a collaboration with Eli Lilly that has led to the discovery of HCV protease inhibitors, and has pioneered novel chemistry and virology-based approaches to design potent and selective compounds that block HCV viral replication. Vertex and Lilly employed computational and combinatorial chemistry techniques to create novel chemical scaffolds, and Vertex developed a proprietary cell-based assay for compound screening. VX-950 exhibits potent antiviral activity and promising pharmacological properties in preclinical testing. During Vertex's collaboration with Eli Lilly, Vertex has led efforts on HCV protease inhibitor drug design, process development and pre-commercial drug substance manufacturing work, and has taken the lead in conducting ongoing toxicology studies. The HCV protease inhibitor field has received renewed attention in recent months, following presentation of the first clinical data on another company's HCV protease inhibitor compound at the American Association for the Study of Liver Disease (AASLD) meeting in November 2002.Background on HCV InfectionHCV infection is a serious disease that causes inflammation of the liver, which may lead to fibrosis and cirrhosis, liver cancer, and ultimately, liver failure. Chronic hepatitis C infection afflicts approximately 2.7 million people in the U.S., many of whom are unaware of their infected status. HCV may go undetected for up to 20 years following initial infection. Worldwide, the disease strikes as many as 185 million people. Each year, 8,000 to 10,000 people in the U.S. die from complications of HCV. Current treatments have been effective for only 40 to 60 percent of chronically infected HCV patients and are associated with significant side effects. At the present time, there are no direct antiviral therapies available for the treatment of HCV infection.About VertexVertex Pharmaceuticals Incorporated is a global biotechnology company. Vertex seeks to discover, develop, and commercialize major pharmaceutical products independently and with partners. Chemogenomics, Vertex's proprietary, systematic, genomics-based platform, is designed to accelerate the discovery of new drugs and to expand intellectual property coverage of drug candidate compounds and classes of related compounds. This approach, which targets gene families, has formed the basis for several commercial collaborations under which Vertex retains rights to downstream revenue. Vertex's first approved product is Agenerase(R) (amprenavir), an HIV protease inhibitor, which Vertex co-promotes with GlaxoSmithKline. Vertex has more than 12 drug candidates in clinical and preclinical development to treat viral diseases, inflammation, cancer, autoimmune diseases, neurological disorders and genetic disorders.This press release may contain "forward-looking" statements, including statements that Vertex's HCV protease research program will produce additional drug candidates, that Vertex anticipates initiating clinical studies with VX- 950 in the second half of 2003, and that HCV protease inhibitors could provide a major clinical advance in treatment of HCV. While Vertex's management uses its best efforts to be accurate in making forward-looking statements, those statements are subject to risks and uncertainties that could cause actual results to vary materially. Those risks and uncertainties include, among other things, the risk that further research may not be successful in identifying additional drug candidates, that preclinical studies may not lead to the initiation of Phase I clinical trials, that clinical trials may not result in a marketable product and that Vertex may be unable to secure regulatory approval of, or successfully market, a drug candidate.
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