Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a China-based pharmaceutical company, has announced preliminary top-line data from a Phase III clinical study for its Category 1 drug, ZSP1273, in adults with simple influenza A. The randomized, double-blind study, conducted across over 80 centers in China, compared the effects of ZSP1273 600 mg QD, oseltamivir 75 mg BID, and a placebo group, with a treatment duration of 5 days followed by a 21-day observation period.
Primary and Secondary Endpoints Achievements
The primary endpoint of the study was the remission time of seven influenza symptoms. The ZSP1273 group showed a median response time of 38.83 hours compared to 63.35 hours in the placebo group (P<0.001), representing a 39% reduction in median response time. Secondary endpoint evaluations revealed that the fever relief time in the ZSP1273 group was 39% shorter than that in the placebo group. Moreover, the median remission time for seven influenza symptoms and fever in the ZSP1273 group was shorter than that in the oseltamivir group, with the disease course in both groups shortened by nearly 10%.
Safety and Efficacy Profile of ZSP1273
In terms of safety, the incidence of adverse reactions for ZSP1273 was similar to that of the oseltamivir group, indicating good overall safety. These results position ZSP1273 as a potential alternative to existing treatments for influenza A.
ZSP1273’s Distinctiveness as an RNA Polymerase Inhibitor
ZSP1273 is noted as the first small molecule RNA polymerase inhibitor to be approved for clinical study in China. Pre-clinical studies have demonstrated that ZSP1273 is significantly more effective than nucleic acid endonuclease inhibitor baloxavir marboxil and neuraminidase inhibitor oseltamivir in inhibiting various Influenza A viruses. The drug also exhibits a strong inhibitory effect on oseltamivir-resistant virus strains, baloxavir marboxil-resistant virus strains, and highly pathogenic avian influenza virus strains.-Fineline Info & Tech
