Statera Biopharma Submits Pilot Study to U.S. FDA

Mar 4, 2022 By MarketDepth

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Statera Biopharma, Inc. (Nasdaq: STAB) recently announced that it submitted a pilot study protocol for STAT-205 treatment of post-acute COVID-19 to the U.S. Food and Drug Administration (FDA).

Pilot Program

The Phase 1 pilot study is set to evaluate the Safety and Efficacy of STAT-205 in approximately 84 patients with Post-acute Sequalae of SARS-CoV-2 infection (PASC). Additionally, STAT-205 for acute COVID is currently being evaluated in Phase 1 clinical trial in adult patients with mild COVID-19 who are at high risk of disease progression.

“Submitting this study protocol to the FDA is a critical milestone in the development of our COVID-19 program. As the world continues to struggle with the COVID-19 pandemic, post-acute COVID syndrome remains a widespread, often debilitating condition that is not well understood. With STAT-205 Statera looks to potentially offer a promising treatment approach to those patients facing the long-lasting burden of the illness.”

Michael K. Handley, President and Chief Executive Officer, Statera Biopharma

Persistent fatigue following COVID-19 is one of the most common symptoms, and no standard of care for PASC exists.