Harbour BioMed, a China-based licensed partner of HanAll Biopharma, announced plans to close its Phase 3 trial of tanfanercept (HBM9036) in dry eye disease (DED), upon completion of the study protocol on the enrolled patients.
The Independent Data Monitoring Committee (IDMC), upon review of the efficacy trend observed to date during the second interim analysis, recommended to Harbour BioMed (HBM) that further enrollment be ceased. However, the currently enrolled subjects will continue to be treated per protocol. No signals for serious safety concerns have been observed to date.
HBM will be following the IDMC recommendation. Once additional data from the remainder of the study becomes available, HBM then will further assess and determine the future plans related to the development of tanfanercept in China.
Phase 3 (study name: VELOS-3) in the US conducted by HanAll Biopharma and Daewoong Pharmaceutical is continuing. The top line results are expected in H1, 2023. DED’s patient demographics, treatment practices, and the regulatory requirement for approval differ by country. Therefore, phase 3 trials in US and China have been conducted separately with different inclusion criteria, primary endpoints, and different regulatory strategies.
- Harbour BioMed fillings: https://www.harbourbiomed.com/upload/202210/1665363745380228213.pdf?downfile=pdf