Ascletis Acquires China Rights To Presidio's HCV Drug

Biotech firm Ascletis and San Francisco-based clinical-stage pharmaceutical company Presidio Pharmaceuticals announced that they have signed into an exclusive licensing agreement for Presidio’s hepatitis C virus (HCV) drug PPI-668.

Under the terms of the agreement, Ascletis gains exclusive rights to develop and market PPI-668, also known as ASC16, in Greater China. Presidio will keep development and commercialization rights to ASC16 in the rest of the world. Ascletis will finance clinical development, manufacturing, and marketing of PPI-668. The company will also pay Presidio upfront and development milestone payments, as well as royalties based on sales in China.

PPI-668 is an investigational once-daily pan-genotypic NS5A inhibitor being developed for the treatment of hepatitis C virus (HCV) infection. Early clinical data shows that PPI-668 was able to achieve average dose-related HCV viral load reductions of greater than 99.9 percent in patients with HCV genotype-1 infection within one to two days of monotherapy. In the past, Presidio has entered into collaboration with Boehringer Ingelheim for the development of PPI-668 in combination with BI’s faldaprevir and deleobuvir as treatment for HCV. The company announced positive trial results for the combo HCV therapy last year.

“This licensing agreement for PPI-668 adds a fourth drug candidate in late-stage development to the Ascletis pipeline, which aims to provide innovative therapeutics for important medical needs in China. Based on the clinical data to date, we believe that PPI-668, in combination with our current direct acting antiviral agent (DAA), danoprevir or ASC08, which has completed Phase 2, offers a potentially effective interferon-free regimen for HCV-infected patients in China,” said Dr. Jinzi J. Wu, Ascletis President and CEO.

Dr. Richard Colonno, Presidio’s Chief Scientific Officer, said, “PPI-668 is a pan-genotypic HCV NS5A inhibitor that has shown high SVR rates in combination with other DAAs in a phase 2 study. We look forward to our collaboration with Ascletis to provide HCV patients with this highly active inhibitor.”