Trial Approval in China Supports Global Development Strategy for TauRx’s Oral Tau Aggregation Inhibitor
We are pleased to confirm receipt of investigative new drug (IND) approval from the National Medical Products Administration (NMPA) in China for study TRx-237-801. dMed-Clinipace, a global CRO based in Shanghai, has been selected as the research partner for this study. IND approval was formally given on 10 March 2022 paving the way for TauRx to build on its global strategy to bring to market the first disease modifying treatment for Alzheimer’s disease targeting the tau pathology of Alzheimer’s disease (AD).
The new trial has been planned to begin recruitment of around 400 participants and their study partners in Q4 of 2022, across an estimated 30 study sites in China, and is anticipated to complete in Q2 2025.
Professor Claude Wischik, Executive Chairman and Co-Founder of TauRx, commented: “I’m particularly delighted that we are able to proceed with this study. It reflects well on the strong Asian footprint of TauRx, which is incorporated in Singapore and has been financed by a largely Asian shareholder base. Our late co-founder, Dr K M Seng, had a vision to bring an effective and accessible treatment for AD to patients in all parts of the world, and we are a step closer to achieving this with the IND approval by the NMPA. We estimate that 60% of the global burden of AD is in Asian countries compared with only 12% in Europe and US combined. We are particularly grateful for the continued loyalty of our shareholders from Singapore, Malaysia, Hong Kong and Indonesia in supporting the expansion of our clinical development program.”