China-based small molecule drug developer Nanjing Zenshine Pharmaceuticals Co., Ltd announced that a Phase II clinical study for its anti-influenza drug ZX-7101A in adult simple influenza has successfully reached the primary endpoint.
Design and Results of the Phase II/III Study
The multi-center, randomized, double-blind, placebo-controlled Phase II/III study is designed to assess the safety and efficacy of ZX-7101A in adult simple influenza. The study consists of a Phase II dosage exploration and a Phase III efficacy confirmation phases. A total of 177 adult patients with simple influenza were included in Phase II, with subjects randomly divided into ZX-7101A (40mg, 80mg) and placebo groups in a 1:1:1 ratio. The results indicated that the primary endpoint of “time to remission of all influenza symptoms” for all dose groups of ZX-7101A was significantly shortened compared to the placebo group. Notably, the median remission time in the 40mg dose group was 44.1% shorter than that of the placebo. ZX-7101A demonstrated significantly shorter remission times for influenza virus RNA negative, 4 systemic symptoms, and 3 respiratory symptoms compared to the placebo group. In terms of safety, ZX-7101A exhibited good safety tolerance, with the incidence of TEAE among subjects comparable to that of the placebo group.
ZX-7101A: A Broad-Spectrum Antiviral with Potent Activity
ZX-7101A is a polymerase acidic protein (PA) endonuclease inhibitor with broad-spectrum anti-influenza characteristics, showing excellent antiviral activity against influenza A, B, and highly lethal avian influenza viruses. The drug has completed patient enrollment for the Phase III clinical study, marking a significant step forward in the development of this potential new treatment for influenza.-Fineline Info & Tech
