TaiGen’s influenza drug cuts symptom duration in late-stage study

18 Apr 2024
firstwordpharma.com
Clinical ResultPhase 3
TaiGen said that in a Phase III study, the investigational oral antiviral TG-1000 significantly shortened the time to alleviation of symptoms versus placebo in adults and adolescents with acute, uncomplicated influenza. The company’s partner Joincare Pharmaceutical is expected to file a marketing application for the drug in mainland China in the second half.
Kuo-Lung Huang, chief executive of TaiGen, remarked that he is “cautiously optimistic” about the potential of TG-1000, given that sales of influenza medicines in mainland China exceeded RMB 6 billion ($829 million) last year, returning to pre-COVID pandemic levels.
The trial randomised 752 patients with uncomplicated acute influenza infection - the majority being type A influenza - to receive either TG-1000 or placebo. The study's primary endpoint was time to alleviation of all influenza symptoms, while secondary goals, which are still being assessed, include antiviral efficacy, symptom resolution, and complications associated with influenza.
Results showed that the median time for alleviating all influenza symptoms in the TG-1000 group was 60.9 hours, significantly shorter than 87.9 hours in the placebo arm. TaiGen noted that TG-1000 had a favourable safety profile, with the frequency of adverse events in both groups being comparable. No deaths or serious adverse reactions were reported.
Along with China, TaiGen plans to explore development of TG-1000 in the US, EU and other Asian markets.
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