TAIPEI, April 17, 2024, TaiGen Biotechnology Company, Limited has announced the successful completion of the phase III study of the influenza antiviral TG-1000 by its partner, Joincare Pharmaceutical. The study revealed that TG-1000 reduced the median time to alleviate all symptoms of influenza compared to a placebo, 60.9 hours vs 87.9 hours, with significant results (P<0.0001).
The trial also confirmed a strong safety profile, with adverse effects like those in the placebo group and no serious adverse reactions or deaths reported. Further analysis of secondary endpoints, such as antiviral efficacy, clinical symptom alleviation, and influenza-related complications, is ongoing.
Main Takeaways
- TG-1000 has shown considerable success in reducing the median time to alleviate all symptoms of influenza compared to a placebo, demonstrating not only efficacy but also a statistically significant improvement in treatment outcomes.
- The phase III trial confirmed that TG-1000 has a strong safety profile, with adverse effects similar to those experienced by the placebo group, and no serious adverse reactions or deaths were reported.
- The completion of phase III trials is a major step following TaiGen's strategic partnership with Joincare Pharmaceutical to handle the development, registration, and commercialization expenses of TG-1000.
"The surge in influenza cases from 2023 to 2024 underscores the persistent threat of flu viruses. The positive outcomes from the TG-1000 Phase III trial represent a significant step forward in influenza treatment," said Kuo-Lung Huang, Chairman and CEO of TaiGen. 1
The phase III trial was a multi-center, randomized, double-blinded study designed to assess the efficacy and safety of TG-1000 in treating uncomplicated acute influenza in adult and adolescent patients. Of the 752 participants enrolled, most were infected with influenza virus A, which aligns with current influenza surveillance data in China.
This milestone follows the exclusive agreement entered on March 22, 2023, with Joincare Pharmaceutical Group Industry Co, Ltd, which took on the responsibility for all development, registration, and commercialization expenses of TG-1000. The agreement included an upfront payment of RMB 20 million to TaiGen, along with milestone payments and royalties. This partnership has been pivotal in TaiGen's strategy to expand the global market presence of TG-1000 after successful phase II trials and marked a significant post-COVID-19 milestone, setting the stage for future international licensing opportunities. 2
Moreover, TaiGen announced the US Food and Drug Administration (FDA) approved the Investigation New Drug application for TG-1000 on November 1, 2020. Emphasizing the significant unmet medical needs for influenza treatment, Huang expressed readiness to commence US clinical trials. With the global market for influenza antivirals projected to grow from $2.34 billion in 2019 to $5.03 billion by 2026, TG-1000 is well-positioned to capitalize on market dynamics that favor endonuclease inhibitors over neuraminidase inhibitors. 3
References
- TaiGen Successfully Completes TG-1000 Phase III Study. PR Newswire. Published April 17, 2024. Accessed April 23, 2024. https://www.prnewswire.com/news-releases/taigen-successfully-completes-tg-1000-phase-iii-study-302120368.html
- TaiGen Enters Exclusive License Agreement with Joincare for TG-1000 in China. PR Newswire. Published March 22, 2023. Accessed April 23, 2024. https://www.prnewswire.com/news-releases/taigen-enters-exclusive-license-agreement-with-joincare-for-tg-1000-in-china-301778308.html
- TaiGen Announces FDA Approval of IND for Its Flu Antiviral TG-1000. PR Newswire. Published November 1, 2020. Accessed April 23, 2024. https://www.prnewswire.com/news-releases/taigen-announces-fda-approval-of-ind-for-its-flu-antiviral-tg-1000-301164444.html
