Nanjing Zenshine Pharmaceuticals has reported that its Phase ll trial of ZX-7101A to treat acute uncomplicated influenza in adults met the primary endpoint.
The company’s anti-influenza agent ZX-7101A demonstrated successful safety and efficacy profiles.
Interim assessment of the Phase ll cohort of ZX-7101A Phase ll/lll adaptive design trial plans to examine the safety and efficacy of ZX-7101A tablets against a placebo.
The trial is a multicentre, randomised, double-blind, placebo-controlled study.
Its adaptive design comprises two relative independent cohorts, Phase ll dose exploration and then Phase lll efficacy confirmation.
Led by National Center for Infectious Diseases (Shanghai) director professor Wenhong Zhang and Huashan Hospital professor Jing Zhang, the trial has been carried out in over 60 centres in China.
The trial’s Phase ll cohort included altogether 177 patients with acute influenza infection.
They were randomised to receive 40mg and 80mg of ZX-7101A as well as a placebo.
Statistical significance was achieved in the primary end point of time to improvement of all influenza symptoms between both the groups treated with ZX-7101A compared to the placebo group.
Besides, the median time to improvement of all influenza symptoms in the ZX-7101A 40mg group was reduced by 44.1% as against the placebo group.
The trial’s secondary efficacy endpoints, such as time to termination of viral shedding determined by RNA virus, time to alleviation of the four systemic symptoms along with time to alleviation of the three respiratory symptoms also showed improvement in both ZX-7101A treatment groups in comparison with the placebo group.
ZX-7101A was also found to be well tolerated with no evident safety data in both groups.
Zenshine Pharmaceuticals chairman Dr Jinfu Yang said: “ZX-7101A could be the best-in-class CEN inhibitor in comparison to all the reported Phase II results.
“Subject enrolment of Phase lll cohort has been completed by March 2023 and the full analysis will be done by mid-2023.
“We expect ZX-7101A to be launched in the near future to help the infected individuals recover fast and to prevent and battle the flu outbreak, which has always been a major threat to public health.”