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Lumosa Has Received Feedback for the Type C Consultation from the US FDA
Corporate
2025.11.28
Lumosa Has Received Feedback for the Type C Consultation from the US FDA
Taipei, Nov. 28, 2025 - Lumosa Therapeutics (Lumosa; 6535.TWO) announced today the receipt of the Type C meeting response from the US FDA (FDA) on the evening of the November 27th. The FDA confirmed that the clinical data accumulated for LT3001 to date are sufficient to support Phase III trial development. The agency agreed with the Company's selection of key patient subgroups based on existing clinical evidence—including moderate-to-severe and disabled patients—as the primary enrollment population for the Phase III trial, which will strengthen data interpretability and increase statistical power.
Regarding the primary efficacy endpoint, the FDA indicated that either mRS 0–2 or mRS 0–1 at 90 days post-treatment would be acceptable as the primary efficacy measure for the Phase III trial and could serve as an important basis for subsequent drug approval review. On the subject of participant ethnicity distribution, the FDA did not require a specific proportion of U.S. participants, emphasizing only that final results must be reasonably generalizable to the U.S. clinical population.
Concerning overall sample size and interim analysis framework, given that interim analysis involves unblinding, the FDA provided specific recommendations on analysis methodology and sample size design. The aim is to ensure the Phase III trial design is sufficiently rigorous and results are more reliable.
Overall, given the urgent and substantial clinical need for acute ischemic stroke treatments, the FDA demonstrated an open attitude toward the LT3001 Phase III trial plan.
Lumosa will adjust its Phase III strategy in accordance with FDA recommendations while accelerating the launch of the China Phase III trial. The Company will continue to advance LT3001's international development using global regulatory standards as its benchmark.
Regarding the primary efficacy endpoint, the FDA indicated that either mRS 0–2 or mRS 0–1 at 90 days post-treatment would be acceptable as the primary efficacy measure for the Phase III trial and could serve as an important basis for subsequent drug approval review. On the subject of participant ethnicity distribution, the FDA did not require a specific proportion of U.S. participants, emphasizing only that final results must be reasonably generalizable to the U.S. clinical population.
Concerning overall sample size and interim analysis framework, given that interim analysis involves unblinding, the FDA provided specific recommendations on analysis methodology and sample size design. The aim is to ensure the Phase III trial design is sufficiently rigorous and results are more reliable.
Overall, given the urgent and substantial clinical need for acute ischemic stroke treatments, the FDA demonstrated an open attitude toward the LT3001 Phase III trial plan.
Lumosa will adjust its Phase III strategy in accordance with FDA recommendations while accelerating the launch of the China Phase III trial. The Company will continue to advance LT3001's international development using global regulatory standards as its benchmark.
