Fusion inhibitor enters Phase III trials

Trimeris Inc. (Durham, NC) and Hoffmann-La Roche Inc. (Nutley, NJ) are initiating two Phase III clinical studies of T-20, the first member of a new class of investigational anti-HIV compounds known as fusion inhibitors. The studies, conducted in North, Central, and South America and in Europe and Australia, will evaluate T-20 when used as part of combination therapy in HIV-infected adults and children.

T-20 inhibits fusion of HIV with host cells before the virus enters the cell and begins its replication process, unlike existing AIDS drug that work inside the cell and target viral enzymes involved in the replication of the virus. T-20, which received fast-track designation by the FDAis being developed through a collaboration between Trimeris and Hoffmann-La Roche.

In the upcoming Phase III trials, the companies will evaluate T-20 in approximately 700 advanced, antiretroviral experienced adults living with HIV/AIDS in over 100 sites around the world. The primary efficacy comparison in the pivotal studies will be the change in the amount of virus in the blood among patients who do and do not receive T-20 when given as a twice daily subcutaneous injection over a 24-week period.

Trimeris is a development stage biopharmaceutical company engaged in the discovery and development of novel therapeutic agents that block viral infection by inhibiting viral fusion with host cells.

Hoffmann-La Roche Inc., the U.S. prescription drug unit of the Roche Group, discovers, develops, manufactures, and markets prescription drugs.

For more information, contact Alex Dusek of Trimeris Inc. at 919-419-6050, or Kellie McLaughlin of Hoffmann-La Roche Inc. 973-562-2231.

Edited by Jim Pomager
Assistant Editor, Pharmaceutical Online