Date: 16-Apr-2020

China NMPA Approves Ascletis Pharma’s IND For HIV Drug ASC09F

Ascletis Pharma Inc, an innovative R&D driven biotech, announces that it received IND approval from National Medical Products Administration (NMPA) for its human immunodeficiency virus (HIV) protease inhibitor ASC09F (ASC09/Ritonavir fixed-dose combination).

ASC09 has an unprecedented high genetic barrier to resistance and has completed phase I and phase IIa clinical trials, which have shown potent anti-viral activity. Previous clinical trials have also shown that ASC09 is safe and well-tolerated. After two weeks of treatment of mono-therapy, ASC09 demonstrated up to a 1.79 log viral load decrease (62-fold reduction of viral load in blood samples of patients).

The studies have shown that ASC09 requires seven mutations before HIV develops resistance to ASC09, indicating ASC09 to have high genetic barrier to resistance compared to other approved protease inhibitors. These characteristics make ASC09 a promising HIV drug therapy candidate for both treatment-naïve and treatment-experienced patients. ASC09 is a potential best-in-class protease inhibitor to treat HIV type-1 infections, licensed as TMC310911 from Janssen R&D Ireland in 2013 for development and commercialization in greater China.

In addition to being a HIV protease inhibitor, ritonavir is a potent CYP3A4 inhibitor. A low-dose of ritonavir can inhibit CYP3A4-mediated metabolism of other HIV protease inhibitors, increase their drug plasma concentration, and boost their overall exposure, thus increase their potency.

"We are excited by IND approval of ASC09F from NMPA,"said Dr. Jinzi J. Wu, founder, chairman and CEO of Ascletis, "adhering to the mission that innovative cures liberate life to the fullest, Ascletis will accelerate the development of innovative drugs to benefit more patients as soon as possible