TAIPEI, Taiwan, August 24, 2022－TaiGen Biotechnology Company, Limited (“TaiGen”) announces today that influenza antiviral TG-1000 phase II study has been completed. Data shows that time to cessation of virus RNA detection, time to cessation of virus titer detection, and time to alleviation of all influenza symptoms after TG-1000 treatment are shorter than those of placebo group. TG-1000 also possesses great safety profile, and there is no clinically significant safety concerns observed.

The phase II trial of TG-1000 is a randomized, double-blinded, multicenter and dose-finding study comparing TG-1000 vs. placebo in patients infected with acute influenza without complication. The purpose of the study is to evaluate the efficacy and safety of influenza patients after receiving TG-1000 treatment. 202 participants are randomly allocated to treatment group (40mg, 80mg, 40+40mg TG-1000) and control group (placebo). In terms of COVID-19 pandemic, all participants are influenza virus B infected which is a rare phenomenon but is consistent with China influenza surveillance data.

The median time to cessation of virus RNA detection of three TG-1000 treatment groups (28.2~42.4 hours) is shorter than placebo group’s (48.1 hours). It shows the tendency of TG-1000 to speed up the virus RNA shedding. Through virus culture, the median time to cessation of virus titer detection of TG-1000 groups (19.5~23.1 hours) is also shorter than that of placebo group (45.8 hours). Data indicates that TG-1000 (combined three groups) accelerates the time of virus inactivation significantly.

Furthermore, the median time to alleviation of all influenza symptoms in both single-dose TG-1000 groups (37.7~45.8 hours in 40mg and 80mg TG-1000 groups) is still also shorter than that of the placebo group (68.2 hours). It demonstrates the tendency of TG-1000 to speed up the alleviation of influenza symptoms.

The incidence rate of adverse effect (AE) of three TG-1000 groups (13.5~20.4%) is similar to that of placebo group (20.4%). All three treatment groups possess favorable safety profile with no serious AE or death occurred.

TaiGen indicates that the out-licensing negotiation of TG-1000 will continue and TaiGen is going to request a pre-phase III meeting with NMPA in order to discuss the study design and dosage level in further phase III study.

About TaiGen Biotechnology
TaiGen Biotechnology is a leading research-based and market-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to Nemonoxacin, TaiGen has an in-house discovered key NCEs: TG-1000, a novel pan-influenza antiviral effective against influenza-A, influenza-B, avian flu H7N7, and Tamiflu-resistant viruses. TG-1000 is currently in Phase 2 clinical study in China and is ready to file phase 3 trial.