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Achieve Life Sciences to conduct additional Phase 2 trial; Phase 3 would be delayed (NEUTRAL)

Achieve Life Sciences, Inc. announced that, based on FDA recommendations, it plans to conduct a Phase 2b optimization trial in the U.S., with various cytisine dosing schedules to evaluate overall treatment efficacy, safety, and compliance profiles for cytisine. Achieve plans to initiate this Phase 2b trial in the fourth quarter of 2018 with top line results expected in the second quarter of 2019 after which, the company would initiate the Phase 3 program. This additional Phase 2 trial would delay the previous schedule for Phase 3, which was planned to start in the beginning of 2019. Nevertheless, it probably increases the chances for more successful Phase 3 trial as “The successful outcome of our discussions with the FDA has provided us with clarity and direction to better inform our Phase 3 clinical development program and our efforts toward expanding cytisine availability,” according to Rick Stewart, Chairman and CEO of Achieve. Recall that Achieve entered into an exclusive supply agreement with Sopharma for the manufacture of cytisine active pharmaceutical ingredient and finished tablets. Under the terms of the agreement, Sopharma agreed to produce GMP-grade cytisine for Achieve's use in the development and commercialization of cytisine.

Source: Achieve Life Sciences; FFBH

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