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Atox ‘Remains On Track’ Despite ACCUTE Setback

CEO Says Reltecimod NDA In NTSI Set For September

 
• By Sten Stovall

After talking with the FDA, Atox will file an NDA for its necrotizing soft tissue infections therapy despite missing primary endpoints in a pivotal trial, the biotech’s CEO tells Scrip.

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Atox hopes to get FDA approval for reltecimod in NTSI by May 2021 • Source: Shutterstock

Atox Bio aims to submit an New Drug Application for its necrotizing soft tissue infections (NSTI) therapy to US regulators in September under the accelerated approval pathway there despite the drug missing a composite primary endpoint in a pivotal study, results from which have just been released, the biotech’s CEO told Scrip.

Atox’s lead asset reltecimod is being evaluated in a Phase III trial called ACCUTE, which stands for AB103 Clinical Composite endpoint

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