Atox Bio reports positive tissue infection trial results

The company today reported positive results of the clinical trial of its drug for the treatment of necrotizing soft tissue infections.

Sources inform ''Globes'' that Atox Bio Ltd. is raising several million dollars from venture capital funds. The fundraising comes as the company announced positive results of a Phase IIa clinical trial of AB103 for the treatment of necrotizing soft tissue infections (NSTI), a life-threatening bacterial infection with significant morbidity and high mortality rate. The study, at six US medical centers found, that the drug was effective and safe. 30 patients received the drug and 10 patients received a placebo.

The clinical trial found that patients treated with AB103 had a meaningful improvement across multiple endpoints compared with a placebo. Patients treated with AB103 had a faster resolution of organ dysfunction, spent fewer days in intensive care units, required fewer days of assisted ventilation, and needed fewer surgical procedures to remove infected tissue. Systemic inflammatory biomarkers also had a faster decline in treated patients compared with a placebo, consistent with the drug’s mechanism of action.

AB103 is a rationally designed, short peptide that modulates the host’s inflammatory response and improves the body’s ability to effectively fight infections. Atox Bio’s approach provides broad-spectrum coverage independent of pathogen type and without the risk of drug resistance.

Atox Bio chief science officer Prof. Raymond Kaempfer and Dr. Gila Arad, from the Faculty of Medicine of the Hebrew University of Jerusalem, founded the company in 2003. Yissum Technology Transfer Company of the Hebrew University of Jerusalem controls the company through Integra Holdings Ltd.

The principle investigator, Dr. Eileen Bulger, a professor of surgery and the Chief of Trauma at the University of Washington Harborview Medical Center, said, “Patients with necrotizing soft tissue infections are critically ill with high rates of mortality, amputation, and large disfiguring wounds. There are few treatment options for this devastating disease. These early results utilizing AB103 suggest a promising new therapy for this disease. We look forward to continuing with a larger clinical trial to establish the optimal treatment regimen."

Atox Bio CEO Dan Teleman said, "AB103 is the first agent being specifically tested for NSTI, a life-threatening and debilitating disease. There are currently no approved treatments specifically for NSTI. Given these clinical trial results and AB103’s US Food and Drug Administration (FDA) fast-track and orphan drug status, we hope to accelerate the development of AB103 and make it available to NSTI patients."

Published by Globes [online], Israel business news - www.globes-online.com - on November 20, 2012

© Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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