TNF Pharmaceuticals And DADA2 Foundation Launch Compassionate Use Study Of Oral TNF-Alpha Inhibitor Isomyosamine For Rare Pediatric Inflammatory Disease

Study evaluates novel small molecule TNF-alpha inhibitor as potential alternative to biologic treatments

TNF Pharmaceuticals, Inc. (NASDAQ:TNFA) ("TNF" or the "Company"), a clinical stage biopharmaceutical company committed to developing novel therapies for autoimmune and inflammatory conditions, today announced that it has formed a philanthropic collaboration with the DADA2 Foundation, a nonprofit organization seeking innovative ways to accelerate research into the rare inflammatory disease DADA2 (Deficiency of Adenosine Deaminase 2). Together, the parties are expected to initiate a Compassionate Use (Expanded Access) study evaluating TNF's lead candidate isomyosamine as a potential treatment.

The DADA2 Foundation describes DADA2 as a rare, monogenic recessively inherited autoinflammatory disease characterized by systemic inflammation, vasculitis, early-onset stroke, immunodeficiency, and bone marrow failure. The condition can lead to recurring childhood strokes at a young age and a high risk of premature death before adulthood. Early diagnosis is critical to minimize systemic organ damage.

TNF President and Chief Medical Officer, Mitchell Glass, M.D. commented, "The body of evidence surrounding DADA2 has shown that TNF inhibition is a most effective treatment for the hyperinflammatory and vasculitic aspects of this disease—a potentially fatal condition that primarily affects children. Compared with standard-of-care biological treatments, our TNF-alpha inhibitor, isomyosamine, is an orally administered small molecule with comparable potency, easier titration to the intended effect and, most importantly, anti-inflammatory action with minimal or no immunosuppression. We believe it could be a superior alternative for treating this devastating disease."

DADA2 Foundation Founder and President, Chip Chambers, M.D. commented, "Biological TNF inhibitors have shown to be the only safe and effective treatment for DADA2 patients with autoinflammatory/vasculitic forms of DADA2, but have many limitations including route of administration, cost, and the potential to lose efficacy over time. We are excited to explore isomyosamine as a potential new treatment to improve the lives of DADA2 patients and their families."

Approximately 25% of DADA2 patients are diagnosed before one year of age and 77% by 10 years of age. Patients who have bone marrow failure tend to present during early infancy, whereas delayed presentation is common in patients with vasculitis affecting medium- and small-sized vessels and systemic inflammation. There are more than 600 DADA2 patients today, but research suggests that 35,000 patients could be affected and undiagnosed globally.1