Arix Bioscience PLC (LON:ARIX) said that portfolio company Atox Bio has had a new drug application accepted by US regulator, the FDA, for reltecimod, an immunotherapy treatment for organ failure in patients suffering from the “flesh-eating” disorder NSTI.
NSTI or necrotizing soft tissue infection is a rare, life-threatening disease that can travel quickly from the infection site and requires frequent, rapid surgical intervention to remove dead and infected tissue to stop further progression and the need for amputation
Atox’s application is for the use of reltecimod in conjunction with surgical debridement, antibiotic therapy, and supportive care.
The date set by the FDA for a decision is September 30, 2021, Arix added.
Hospital discharge data indicates there are approximately 30,000 cases of NSTI in the US each year, with a similar number in Europe.
If approved, reltecimod would be the first therapy to treat suspected organ dysfunction or failure in patients with NSTI
In a statement, Jonathan Tobin, managing director at Arix and a board director at Atox Bio, said: “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.”
Dan Teleman, Atox Bio’s chief executive, said: “The development of reltecimod reinforces Atox Bio’s expertise in immunotherapy”.