Atox Bio announces FDA acceptance of New Drug Application

• Necrotizing soft tissue infection (NSTI) is a rare, life-threatening disease that involves significant necrosis and tissue destruction coupled with systemic organ failure

• Reltecimod marketing authorisation by the FDA would provide physicians with the first therapy to treat suspected organ dysfunction or failure in patients with NSTI

• FDA sets PDUFA date for 30 September 2021

LONDON, 11 December 2020: Arix Bioscience plc (“Arix”, LSE: ARIX) a global venture capital company focused on investing in and building breakthrough biotech companies, notes that its portfolio company Atox Bio, announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for reltecimod. The proposed indication is for the treatment of suspected organ dysfunction or failure in patients with NSTI in conjunction with surgical debridement, antibiotic therapy, and supportive care.

The Prescription Drug User Fee Act (PDUFA) date set by the FDA, which is the goal date for a decision on the NDA, is 30 September 2021.

Jonathan Tobin, Managing Director at Arix and Board Director at Atox Bio, commented:

“The NDA acceptance marks an important step forward in Atox Bio’s development of reltecimod for patients with NSTI, a devastating and potentially fatal disease for which there is no approved treatment.”

The announcement can be accessed on Atox Bio’s website at https://www.atoxbio.com/news/ and full text of the announcement from Atox Bio is contained below.