Pivotal Phase III trial of HIV MAb ibalizumab successful

New data presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2017 showed that patients with multidrug resistant (MDR) HIV-1 infection experienced a mean increase in CD4+T cell of 48 cells/µL after 24 weeks of treatment with ibalizumab plus an optimized background regimen (OBR), according to Canadian specialty pharma company Theratechnologies (TSX: TH).

Ibalizumab is the first-ever antibody HIV treatment, said Christian Marsolais, senior vice president and chief medical officer of Theratechnologies, which has exclusive rights to commercialize ibalizumab in the USA and in Canada from Taiwan-based TaiMed Biologicals (4147: TT).

These data supplement previously reported findings, where 83% of patients achieved a ≥ 0.5 log10 decrease in viral load from baseline seven days after the single loading dose of 2000mg of ibalizumab (primary endpoint) and a mean reduction in viral load of 1.6 log10 over the 24 week treatment period with more than 48% of patients experiencing a viral load reduction of more than 2.0 log10.

The results support the upcoming US Food and Drug Administration submission and, if approved, ibalizumab will be the first antiretroviral treatment with a new mechanism of action to be approved in close to 10 years.

"CD4+T cells play an important role in protecting the body from infection. The higher the CD4+T cell count, the better able you are to fight HIV and other infections," said Dr Brinda Emu, assistant Professor of Medicine, Infectious Diseases, Yale School of Medicine, New Haven, CT. "This meaningful increase in CD4+T cell counts is particularly important for patients with multidrug resistant virus, as they often have the most advanced disease. These data suggest that for these patients, ibalizumab could be an important new treatment option," added Dr Emu.

Ibalizumab has been awarded Breakthrough Therapy status by the FDA, as well as orphan status, based on preliminary clinical evidence indicating that it may represent a substantial improvement over existing therapies on one or more clinically significant endpoints.