News Feature | August 7, 2014

Atox Bio's NSTI Drug Granted Orphan Status In The EU

By Estel Grace Masangkay

orphan drug

The European Commission has designated Atox Bio’s AB103 Orphan Medicinal Product status for the treatment of necrotizing soft tissue infections (NSTI).

AB103 is a short peptide that modulates inflammatory response by binding to a key interface in the immune system. The drug works to target the host response rather than the pathogen to preclude drug resistance.

Necrotizing soft tissue infections are rare but fast progressing infections that wreak major tissue destruction and systemic disease contributing to multiple organ dysfunctions. Standard of care includes repetitive surgical debridement, resuscitation, and physiologic support in addition to antibiotic regimens. There are currently no approved drugs for NSTI, making the condition a current unmet medical need, and one which helped urge the FDA to award the novel immunomodulator Fast Track designation in 2012 for the treatment of NSTI.

“Patients with necrotizing soft tissue infections have a devastating disease with a high risk of death. Those who survive require multiple surgeries and many require amputations. We are excited to explore new treatment options to help manage these critically ill patients. It is our hope that AB103 will be a valuable adjunct in the management of this disease,” commented Dr. Eileen Bulger at the time of Fast Track designation. Professor Bulger specializes in Surgery and is Chief of Trauma at the University of Washington Harborview Medical Center.

Last year Atox Bio published data in the Journal of Infectious Diseases that shows a single dose of AB103 administered a few hours after onset of infection increased survival in animal models of the disease. The drug candidate also decreased tissue necrosis and inflammation without interfering with immune response.

Commenting on the orphan designation, Atox Bio CEO Dan Teleman said, “Obtaining orphan designation for AB103 in the European Union is an important regulatory milestone for Atox Bio, supporting our global development plan after having received Orphan Drug designation and Fast Track status from the FDA. We are continuing development to bring to patients what could be the first therapy for this devastating and rare disease.”