TEL AVIV, Sept 10 (Reuters) - Israeli biotechnology firm Atox Bio said the U.S. Food and Drug Administration has granted fast track designation to AB103, its product in development for the treatment of necrotizing soft tissue infections (NSTI), also known as flesh-eating bacteria.
Fast track programmes facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and that demonstrate the potential to address unmet medical needs, the company said on Monday.
The benefits of fast track include scheduled meetings to seek FDA input into development plans and the option of submitting a new drug application in sections rather than all components simultaneously. These meetings can help the FDA and sponsors reach early agreement on design of the clinical efficacy studies that will be needed to support approval.
“This is a major milestone for Atox Bio that comes after the FDA has granted AB103 orphan drug designation in October 2011,” said Dan Teleman, Atox Bio’s chief executive.
Teleman told Reuters last week the company expects to have results of Phase II clinical trials underway at seven U.S. medical centres by the end of the year. Atox Bio expects to ask investors for more money this year to fund extended phase II trials.
Currently, there are no approved treatments for 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,” said Eileen Bulger, professor of surgery and chief of trauma at the University of Washington Harborview Medical Center. (Reporting by Tova Cohen)