Tonix Pharmaceuticals' CEO, Dr. Seth Lederman, participated in the "Endpoints" panel at the RECOVER Treating Long COVID (TLC) workshop, held September 23-25 in Bethesda, MD. The panel addressed suitable clinical trial endpoints for Long COVID therapeutics, emphasizing the need for meaningful data to support regulatory approval.
Advocating for PGIC as a Primary Endpoint
Dr. Lederman proposed that the RECOVER-TLC team engage with the FDA to validate the Patient Global Impression of Change (PGIC) as a primary endpoint for therapeutic trials, particularly in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME)-type Long COVID. He highlighted the FDA's recent draft guidance on patient-reported outcomes (PROs), which recognizes PGIC as a potential endpoint.
"I believe the development of Long COVID drugs should emulate the highly successful regulatory pathway established for cancer drugs," said Dr. Lederman. He drew a comparison between PGIC's potential role in Long COVID drug development and Progression-Free Survival (PFS) in cancer drug approvals, suggesting that PGIC could serve as an appropriate endpoint for accelerated approvals in CFS/ME and Long COVID.
Tonix's Experience with TNX-102 SL
Tonix Pharmaceuticals is developing TNX-102 SL for Fibromyalgia-type Long COVID and expects to submit a New Drug Application (NDA) to the FDA in October for fibromyalgia. Dr. Lederman shared insights from the development of TNX-102 SL, noting the relevance of their findings to Long COVID research.
RECOVER Initiative
The National Institutes of Health (NIH) established the RECOVER Initiative to address the diverse manifestations of Long COVID, which affects millions of Americans. RECOVER aims to unite clinicians, scientists, caregivers, patients, and community members to better understand, treat, and prevent Long COVID.
Tonix Pharmaceuticals' Broader Pipeline
Tonix Pharmaceuticals is a biopharmaceutical company focused on pain management and public health solutions. Their pipeline includes TNX-1300, a biologic in Phase 2 development for cocaine intoxication, and TNX-1500, a monoclonal antibody targeting CD40-ligand for preventing allograft rejection and treating autoimmune diseases. They are also developing TNX-2900 for Prader-Willi syndrome and TNX-801, a vaccine for mpox. Additionally, Tonix has secured a contract with the U.S. Department of Defense to develop TNX-4200, broad-spectrum antiviral agents targeting CD45.
