Atox Bio announced that the first patient has been enrolled in the Phase 2 REAKT (Reltecimod E fficacy for Acute Kidney Injury Trial) study.
The Phase 2 randomized, placebo-controlled study, will enroll 120 patients with abdominal sepsis and stage 2/3 AKI (as described by KDIGO criteria) at approximately 50 level 1 trauma centers in the U.S. Patients will receive Reltecimod or placebo, administered as a single dose within 6 hours of the diagnosis of AKI, in addition to standard of care treatment. The primary endpoint is complete recovery from stage 2/3 AKI, defined as alive, free of dialysis and return of serum creatinine to
In parallel, Atox Bio is conducting the ACCUTE Phase 3 study evaluating Reltecimod in patients with Necrotizing Soft Tissue Infections.
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"We are pleased to be initiating the Phase 2 REAKT study. With this study, we are expanding the potential uses of Reltecimod to additional indications in the critical care setting where severe acute inflammation plays a role in the morbidity and mortality of patients,” Dan Teleman, CEO of Atox Bio, said. We look forward to closely collaborating with all the high caliber clinical sites, all of which are participating in both the REAKT and ACCUTE studies."
Reltecimod (AB103) is a rationally designed peptide that binds to the CD28 co-stimulatory receptor and restores the host's appropriate immune response to severe infections. By modulating, but not inhibiting, the body's acute inflammatory response, Reltecimod is designed to help control the cytokine storm that could otherwise quickly lead to morbidity and mortality. Reltecimod received Orphan Drug status from the FDA and EMA as well as Fast Track designation for the NSTI indication.
Acute Kidney Injury (AKI) involves inflammatory processes in the kidney which can lead to permanent reduction of kidney function and is also associated with an increased risk of death, extended hospitalization, and increased medical cost. AKI affects annually around 3 million patients in the US, Europe and Japan. There are currently no approved therapies to treat AKI and the only treatment options are dialysis and supportive care.