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...