Atox Bio Announces Enrollment of First Patient in Phase 2 Study of Acute Kidney Injury (AKI)

Ness Ziona, Israel and Chapel Hill, NC – May 29, 2018 – Atox Bio, a clinical stage biotechnology company developing novel therapies for critically ill patients, today announced that the first patient has been enrolled in the Phase 2 REAKT (Reltecimod Efficacy 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 <150% of reference baseline. Important secondary endpoints include survival, resolution of organ dysfunction and other health economic outcomes such as days on the ventilator, days in the ICU, duration of hospital stay and need for hospital readmission.

In parallel, Atox Bio is conducting the ACCUTE Phase 3 study evaluating Reltecimod in patients with Necrotizing Soft Tissue Infections. Dan Teleman, CEO of Atox Bio, stated, “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. 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.”

About Reltecimod
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.

8 Sapir St., Ness Ziona 74036, Israel, www.atoxbio.com
Tel: +972-8-648-4111