SEATTLE and VANCOUVER, British Columbia - Achieve Life Sciences, Inc. (NASDAQ:ACHV), a pharmaceutical company advancing cytisinicline for smoking cessation, announced an agreement with the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) data requirements.
The FDA has supported an NDA submission based on efficacy data from two Phase 3 trials, ORCA-2 and ORCA-3, with additional long-term safety data to be provided.
The agreement, reached after discussions in the fourth quarter of 2023, stipulates that a single open-label study for long-term safety exposure of cytisinicline will suffice. This study, ORCA-OL, is set to begin in the second quarter of 2024 and will recruit over 1,700 subjects from previous ORCA trials. Achieve plans to submit safety data from at least 300 subjects treated for six months and 100 subjects for a cumulative duration of one year before potential approval.
Anticipated in the first half of 2025, the NDA submission will combine existing treatment data with new findings from the ORCA-OL trial. This approach aims to expedite the collection of long-term exposure safety data. The trial will monitor subjects receiving cytisinicline treatment for up to one year, with expectations that the data will also support label expansion for vaping cessation.
In parallel, Achieve announced a financing round of approximately $124.2 million, including $60 million from common stock sales and up to $64.2 million from milestone-driven warrants. The company has also reached a non-binding agreement with Silicon Valley Bank to extend the maturity date of its outstanding loan into December 2025.
John Bencich, CEO of Achieve, expressed confidence in the company's financial position to conduct the ORCA-OL trial and complete the NDA submission. The funding is expected to be sufficient through the NDA filing and potentially through FDA approval, with additional runway into 2026 if all warrants are exercised.
Cytisinicline, a plant-based alkaloid, is designed to interact with nicotine receptors in the brain, potentially easing withdrawal symptoms and reducing the satisfaction associated with nicotine products. It is currently an investigational candidate and has not received FDA approval.
This announcement is based on a press release statement.
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