Positive effect of reltecimod on resolution of organ dysfunction in phase III ACCUTE trial for patients with necrotizing soft tissue infection .- Atox Bio

Atox Bio announced results from the randomized, double-blind, placebo-controlled Phase III ACCUTE (AB103 Clinical Composite endpoint StUdy in Necrotizing Soft Tissue infEctions) trial of reltecimod for the early treatment of severe Necrotizing Soft Tissue Infection (NSTI). The data showed a significant difference in the percentage of patients administered reltecimod who achieved resolution of organ dysfunction/failure by Day 14 vs. the percentage of patients who received placebo. Resolution of organ dysfunction by day 14 has been noted in the literature and was shown in this trial to have a beneficial effect on 90-day mortality. As this was the first pivotal study ever performed in NSTI, a necrotizing infection clinical composite endpoint (NICCE) was developed. This endpoint was designed to assess both the local and systemic components of NSTI and included the measurement of resolution of organ dysfunction/failure. While statistical significance on the primary composite endpoint was not achieved in the modified intent to treat (mITT) population,the efficacy assessment in the clinically evaluable (CE) population demonstrated a p-value=0.039. Atox Bio believes that, the CE population reflects the more clinically relevant and statistically appropriate patient population for evaluation of the treatment effect of reltecimod. Atox has reviewed the topline results of this trial with the FDA and, based on these discussions, plans to submit a New Drug Application (NDA) to the FDA in Q3 2020 under the Accelerated Approval Pathway with resolution of organ dysfunction being the basis for this approval pathway. The company aims to commercialize reltecimod for NTSI in the US on its own. There are about 30,000 patients annually in the US, with the majority of patients treated at trauma centers so a reasonably small commercial team can target most of the treatment hospitals . In Europe, where it will file an MAA (in full) around September 2021, Atox will seek a partner.