Cell therapy developer Taiwan Bio Therapeutics announced results from its Phase IIb clinical trial for osteoarthritis (OA). While the primary pain reduction endpoint did not show statistically significant improvement compared to the hyaluronic acid control group, the study revealed notable efficacy in secondary endpoints, particularly in joint structure improvement—a result rarely seen among competing products. This outcome has become a major highlight, and the company now intends, together with its Singapore licensing partner, to accelerate the launch of Phase III trials, aiming to begin patient enrollment both domestically and internationally by the end of this year, though overseas enrollment may be slightly lower than initially projected.

Taiwan Bio Therapeutics has previously licensed the Asia-Pacific rights (including Taiwan) of its OA cell therapy candidate to Singapore-based Senectus, while retaining responsibility for conducting domestic clinical trials. The recently announced Phase IIb trial was a single-blind, randomized study. Results showed no statistically significant difference in the primary pain reduction endpoint compared with the hyaluronic acid control group. However, secondary endpoints demonstrated significant improvement in joint structure, as measured by WORMS (Whole-Organ Magnetic Resonance Imaging Score), compared with the control group.

Chief Executive Officer Cyrus Yang stated that improvements in joint structure are rarely observed with current OA therapies, as most treatments target symptoms rather than underlying disease mechanisms. Based on these Phase II findings, the company plans to adjust and expedite Phase III development in collaboration with its strategic partner. In prior discussions with Taiwan’s TFDA, regulators had already been briefed on the Phase II trial trends. The Phase III study will still focus primarily on pain reduction as the main efficacy endpoint, but the control arm will be switched to placebo, while joint structure improvement will also be incorporated as a secondary endpoint for regulatory review.

Internationally, the company’s partner plans to first seek Phase III trial approvals from health authorities in Singapore and Malaysia. The trial design may adopt a cross-over enrollment and dosing strategy to reduce the required number of participants.

Taiwan Bio Therapeutics and its partner are set to receive the full closing report of the Phase II trial from the CRO in the near future. Once received, they will submit supplementary documentation to both domestic and overseas regulators, with the goal of initiating Phase III enrollment in Taiwan and abroad before the end of this year.

Resource: 台寶:OA二期次要指標達標成亮點，期加速啟三期