Tourmaline Bio announced that: It is planning to commence a pivotal Phase 3 trial for TOUR006 in TED in 2024. This second pivotal trial will replace the previously planned TED basket trial and does not impact Tourmaline’s expected cash runway through 2026. Topline data from the ongoing Phase 2b spiriTED trial are expected in the first half of 2025 and topline data from the planned Phase 3 trial in TED are expected in 2026. Alignment has been reached with the U.S. Food & Drug Administration on the ASCVD clinical development program, including a Phase 2 trial evaluating the reduction of C-reactive protein, a validated biomarker for inflammation, with quarterly dosing of TOUR006 in patients with elevated cardiovascular risk. This trial is targeted to commence in the first half of 2024, with topline data expected in the first half of 2025. Pending success, the results from the Phase 2 trial are expected to position Tourmaline to be ready in 2025 to commence a pivotal Phase 3 trial in cardiovascular disease.
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