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Time: 2018/08/30

Frontier Biotech's novel long-acting, all-injectable anti-HIV two-drug combo IND allowed by the US FDA

Frontier Biotech announced today its IND of novel long-acting, all-injectable anti-HIV two drug combo (albuvirtide for injection, ABT and 3BNC117) was allowed by the US FDA on August 14th 2018, and the company will start a phase II clinical trial of the combo therapy in the US soon.

ABT is the first new HIV medicine discovered and developed in China and the second long-acting HIV drug in the world. With novel molecular mechanism of action and long-acting activity against HIV-1, ABT received marketing authorization from CNDA (formerly CFDA) in May 2018. Clinical data showed that ABT was safe and effective against major strains of HIV including resistant viruses.

3BNC117 is a novel broad-spectrum HIV neutralizing antibody (bNAb). 3BNC117 is one of the most effective bNAbs. Several phase 1 and phase 2 clinical trials have been conducted in the US, showing 3BNC117 not only blocks viral replication like other AIDS drugs, but also induces immune response to HIV and HIV-infected cells.

Combining ABT and 3BNC117, Frontier Biotech is developing an all-injectable, long-acting, two-drug regimen that has novel mechanism of action for the treatment and prophylaxis of HIV infection and AIDS. Frontier Biotech will explore the potential of the combination regimen as a complete solution to replace daily oral drugs as well as to achieve drug-free sustained viral remission through antibody-mediated immunotherapy.

Dr. Dong Xie, founder, chairman and CSO of Frontier Biotech said, “We are dedicated to the discovery, development, and commercialization of innovative drug products addressing significant unmet medical needs. The NDA approval of ABT in China was a major milestone. With US FDA’s allowance of the two-drug combo IND, we will continue making best efforts to develop a complete regimen with all-injectable long-acting new drug combination and provide preferred solutions to HIV patients globally.”