The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for reltecimod (Atox Bio) for the treatment of suspected organ dysfunction or failure in patients aged 12 years and older with necrotizing soft tissue infection (NSTI), in conjunction with surgical debridement, antibiotic therapy, and supportive care.
Reltecimod is a synthetic peptide antagonist of both superantigen exotoxins and the CD28 T-cell costimulatory receptory. The drug is designed to modulate the acute inflammatory response observed in patients with NSTI that leads to organ dysfunction or failure.
The NDA submission is supported by data from the randomized, double-blind, placebo-controlled phase 3 ACCUTE study that assessed the efficacy and safety of reltecimod in 290 patients aged 12 years and older with NSTI receiving standard of care therapy. Patients were randomized to receive reltecimod 0.5mg/kg intravenously as a single dose or placebo.
The co-primary end points were the necrotizing infection clinical composite success end point (NICCE) and the modified clinical composite end point. The NICCE included a modified sequential organ failure assessment score to evaluate resolution of organ dysfunction.
Results showed that among patients in the clinically evaluable analysis, 52.6% of those treated with reltecimod achieved clinical success on the NICCE primary end point compared with 40.3% of the placebo arm (P =.039). Moreover, 70.9% of patients treated with reltecimod achieved resolution of organ dysfunction by day 14 compared with 53.4% for placebo (P =.005). However, an analysis of the modified intent to treat (mITT) population showed that reltecimod did not achieve statistically significant clinical success compared with placebo, 48.6% vs 39.9%, respectively (P =.14).
As for safety, reltecimod was found to be well tolerated with similar adverse events to placebo. The most common adverse events reported in the reltecimod and placebo arms were anemia (6.3% vs 4.8%), acute kidney injury (5.6% vs 5.4%), atrial fibrillation (4.9% vs 6.8%), and peripheral edema (4.9% vs 1.4%), respectively.
The FDA previously granted Fast Track and Orphan Drug designations to reltecimod for this indication. A Prescription Drug User Fee Act (PDUFA) target date of September 30, 2021 has been assigned for this application.
For more information visit atoxbio.com.
1. Atox Bio announces FDA acceptance to file the NDA for reltecimod to treat suspected organ dysfunction or failure in patients with necrotizing soft tissue infection (“flesh-eating disease”). [press release]. Durham, NC and Ness Ziona, Israel: Atox Bio; December 10, 2020.
2. Atox Bio announces a positive effect of reltecimod on resolution of organ dysfunction in phase 3 ACCUTE trial for patients with necrotizing soft tissue infection (“flesh eating disease”). [press release]. Durham, NC and Ness Ziona, Israel: Atox Bio; July 10, 2020.