2018-09-07| Trials & Approvals

US FDA Allows Phase II Clinical Trials for China’s anti-HIV Two-Drug Combo Therapy

by Rajaneesh K. Gopinath
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By Rajaneesh K. Gopinath, Ph.D.

Just months after the landmark CFDA approval of its HIV fusion inhibitor, Nanjing-based Frontier Biotechnologies Inc. has achieved yet another significant milestone

Albuvirtide (trade name Aikening) is China’s first domestically developed and the world’s second long-acting, injectable anti-HIV drug. Debuting in November 2016, it was eventually approved for marketing by the China Food and Drug Administration (CFDA) in May this year. This is one of the few rarest instances when a drug has been approved directly without a preceding approval in the US or Europe.

By blocking the attachment and fusion of the virus with host CD4 cells, Albuvirtide interrupts the HIV-l cycle in its earliest stage. It is injected once a week and is safer than existing alternatives due to its lower side effects. Results from the phase III clinical trials (TALENT study) showed that Aikening was quite effective against major strains of HIV including resistant viruses and its efficacy is much better compared to the WHO-approved second line of treatment currently available. Back in 2017, Frontier Biotechnologies Inc. had signed a license agreement with Rockefeller University to make a coformulation of Albuvirtide and 3BNC117, a novel broad-spectrum HIV neutralizing antibody (bNAb). This monoclonal antibody was found to be very potent in numerous prior clinical trials.

On August 15th, 2018, the company announced in an official press release that the US FDA has given the green signal for its investigational new drug application (IND). This has enabled the company to soon start a phase II clinical trial of an all-injectable anti-HIV two-drug combo (albuvirtide for injection, ABT and 3BNC117) in the US. Besides blocking viral replication, 3BNC117 also induces an immune response against HIV positive cells. In conclusion, this antibody-mediated immunotherapy possesses a novel mechanism of action for the treatment of AIDS. It also promises to eliminate the practice of daily oral drugs, as well as achieve drug-free sustained viral remission.





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