Benzinga | Dec 20, 2021 04:03PM EST

Statera Biopharma Reports First Patient Dosed In STAT-205 Study For Acute COVID

Initial Study to Evaluate Pharmacokinetics, Biomarkers and Safety of STAT-205

Targeting Preliminary Data 2022

FORT COLLINS, Colo., Dec. 20, 2021 (GLOBE NEWSWIRE) -- Statera Biopharma (NASDAQ:STAB), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, announced today the enrollment and randomization of the first patient, with several more in screening for an initial study to evaluate STAT-205 as a potential treatment to mitigate SARS-CoV-2 progression, the virus that causes COVID-19. STAT-205 is an immune-modulator designed to decrease elevated inflammatory responses associated with cytokine production and modulate the Th1/Th2 helper cells to control immune dysfunction.

"We look forward to working with the researchers to explore the potential of STAT-205 as an oral cost-effective therapeutic option for patients with COVID-19," stated Michael K. Handley, President and Chief Executive Officer, Statera Biopharma. "We expect preliminary trial results to be reported in 2022."

"Now that vaccines are widely available, developing safe and effective treatments for people who contract COVID-19 is our next challenge. Statera Biopharma is one of the first companies to modulate the immune system function to decrease elevated inflammatory responses associated with SARS-CoV-2 viral infections," said George P. Azar Jr., MD, FCCP, Board Certified Pulmonologist of the Clinical Research Center of Florida. "This approach has the potential improve outcomes for countless patients and impact the landscape of the pandemic with a cost-effective therapeutic treatment for COVID-19. I am excited that our site has randomized the first patient in the clinical trial of STAT-205."

The randomized, single-blind, placebo-controlled study will enroll 24 patients that are age 18 years or older who test positive for acute SARS-CoV-2 and show symptoms of mild infection that are at high risk for disease progression. The study is designed to assess the pharmacokinetics (PK), early predictive biomarkers, and safety of STAT-205.

In preclinical in vitro studies, STAT-205 demonstrated the potential to inhibit the replication of coronaviruses in human lung cells.