In the news ... 2008

Trimeris to shut down R&D, focus on TRI-1144

by Paul Dalton, January 10, 2008

Trimeris Pharmaceuticals announced it is shutting down all new product research and development and will focus its efforts on its experimental entry inhibitor, TRI-1144. They plan to file an Investigational New Drug application for TRI-1144 with the Food and Drug Administration (FDA) early in 2008, and begin phase I clinical studies soon after.

This decision to end new product development is risky for Trimeris. They have yet to study TRI-1144 in humans. Many drugs that look promising in pre-clinical research fail when given to people. This decision leaves the small company with no back-up compound, or program to develop one, if TRI-1144 fails.

Trimeris originally developed the fusion inhibitor Fuzeon (enfuvirtide) and partnered with Roche for its manufacturing and marketing. In 2007, the companies announced they would no longer work together on the R&D of new drugs.

This latest development follows a series of setbacks for Trimeris. In addition to severing its relationship with industry giant Roche, the company underwent major restructuring. As reported here, they failed to gain FDA approval for a needleless injection system for Fuzeon. Lastly, the approvals of Selzentry (maraviroc) and Isentress (raltegravir)—along with the imminent approval of Intelence (etravirine, TMC-125)—have likely reduced the need for Fuzeon by people with extensive treatment experience.

Data on TRI-1144 have been reported at several conferences over the past two years. Like Fuzeon, it blocks HIV’s entry into immune system cells by blocking the viral protein, gp41. As with Fuzeon, it must be injected. However, lab testing suggests it may be given as little as once a week. TRI-1144 also appears likely to cause fewer site reactions than enfuvirtide, a major concern for many, as well as appears to have a high barrier to resistance while remaining active against HIV that has become resistant to enfuvirtide.

Project Inform sees this as a setback: yet another example of the anticipated but troubling industry-wide slow-down of HIV drug development. While the last few years have witnessed a bumper crop of important new treatment options, the next few years look thin. New drugs like Isentress and Selzentry, along with older options like Prezista (darunavir) and Fuzeon, have helped many people with highly drug-resistant HIV to reach undetectable levels of HIV, often for the first time.

History has shown us that however good these new drugs are, they are not going to work forever for this group of people. New treatment options will be needed for this medically vulnerable group. Today, there’s one fewer company working on the much needed next generation of HIV drug.