The Phase 2 trial was the first randomized, double blind, placebo controlled study in patients with NSTI and was conducted at 7 high quality trauma sites across the US.
40 randomized patients – 10 Placebo, 15 Reltecimod 0.25 mg/kg and 15 Reltecimod 0.5 mg/kg received a single dose of either Reltecimod or placebo administered within 6 hours of clinical diagnosis.
The study demonstrated consistent responses across multiple clinically relevant end points and no observed drug-related adverse effects.
Reltecimod demonstrated a statistically significant effect in regards to organ dysfunction as measured by a very low total SOFA score ( SOFA is a validated tool used in many critical care studies, and is comprised of 6 major organ systems – respiratory, cardiovascular, renal, coagulation, CNS and liver) at study Day 14 when compared to placebo. A total SOFA score of zero or one is indicative of clinical well-being or only mild changes in organ function.
Distribution of SOFA- Clear treatment effect on resolution of organ dysfunction
Additional results reflecting a consistent response associated with Reltecimod treatment on local manifestations (debridements) and clinical outcomes associated with the systemic manifestations of NSTI (days in the ICU and on the ventilator along with overall mortality) are shown in the table below.
Consistent response across multiple clinically relevant end points
Bulger, E.M., Maier, R.V., Sperry, J., Joshi, M., Henry, S., Moore, F.A. et al, JAMA Surg. 2014;149(6):528-536
Retrospective study confirms study design for pivotal Phase 3 trial
Clinical and laboratory based information on 198 patients receiving standard of care in a contemporaneous NSTI patient population. The study evaluated the criteria for severity of disease at baseline to assist in patient selection/stratification, a composite clinical endpoint and its components along with the overall feasibility of recruiting patients to a pivotal Phase 3 trial in this orphan indication.
The Retrospective study confirmed that patients with more severe disease (as measured by a modified SOFA scoring tool) at baseline should be the target population for Phase 3 trial. The study also confirmed that the composite clinical endpoint (Necrotizing Infection Composite Clinical Endpoint-NICCE) was associated with decreased utilization of hospital resources, improved rate of recovery from AKI and ability to clearly differentiate responders from non-responders.