By Kim Coghill
Developers of a new class of an HIV drug designed to treat patients who are resistant to drugs currently on the market said their product entered Phase III trials and they hope to launch it by the end of 2002.
T-20, a fusion inhibitor owned by Durham, N.C.-based Trimeris Inc. and Nutley, N.J.-based Hoffman-La Roche Inc., will be tested in two Phase III pivotal studies in individuals who have failed or become resistant to other drugs. The proposed drug has fast-track status.
"T-20 is not a cure, but it will deal with multidrug resistance by stopping the virus before it enters the cell," said Dani Bolognesi, CEO, director and co-founder of Trimeris.
Unlike existing AIDS drugs that work inside the cell and target viral enzymes involved in the replication of the virus, T-20 inhibits fusion of HIV with host cells before the virus enters the cell and begins its replication process.
Because T-20 works outside the cell, it doesn't have the opportunity to interfere with cellular processes that are internal, Bolognesi said. "[T-20] doesn't have the toxicities and drug interactions of some of the things that plague the current molecules that are out there.
"It attacks the target and therefore is not cross resistant with the other drugs. A virus that is resistant to the current drugs is susceptible to this drug," he said. "It has a very remarkable safety profile in addition to being active in a different target. It is going to be welcomed by many patients who are not able to tolerate the current drugs."
T-20 will undergo two 24-week trials, one in North, Central and South America, and the other in Europe and Australia. A total of 1,000 patients will participate.
The primary efficacy endpoint 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 the 24-week period.
Bolognesi said T-20 likely will be used with other combination drugs and it will not be exclusive to drug-resistant patients.
Trimeris also is testing T-1249, another fusion inhibitor product candidate. The drug is in Phase I/II clinical testing and also has fast-track status.
Alex Dusek, director of marketing for Trimeris, said T-20 is at least two years ahead of T-1249 but he expects the company to present data on the latter candidate early next year. Preliminary data show that T-1249 might be effective in people who are resistant to T-20.
Trimeris' stock (NASDAQ:TRMS) closed Tuesday at $66.34, down 97 cents.