Statera Biopharma Submits Phase 1 Clinical Trial Protocol to FDA for Investigational Treatment of Long-Haul COVID-19

Statera developing STAT-205 as novel therapy for immune modulation in treating post-acute (long-haul) patients with SARS-CoV-2 (COVID-19)

FORT COLLINS, Colo., March 02, 2022 (GLOBE NEWSWIRE) — Statera Biopharma, Inc. (Nasdaq: STAB), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, today announced submission to the U.S. Food and Drug Administration (FDA) of its pilot study protocol for STAT-205 treatment of post-acute (long-haul) COVID-19.

“Submitting this study protocol to the FDA is a critical milestone in the development of our COVID-19 program,” said Michael K. Handley, President and Chief Executive Officer, Statera Biopharma. “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.”

The Phase 1 pilot study, A Randomized, Double-blind Study to Evaluate the Safety and Efficacy of STAT-205 in Patients with Post-acute Sequalae of SARS-CoV-2 infection (PASC), will evaluate the efficacy of STAT-205 compared with placebo for reducing fatigue in PASC. In addition, the study will evaluate the efficacy of STAT-205 compared to placebo for cognition improvement in patients, as well as safety of the therapy. Approximately 84 patients will be enrolled.

Immunomodulators appear to potentially reduce the pathogenicity of the condition by balancing immune function through toll-receptor binding that may lead to ongoing inflammation and symptom persistence. STAT-205 may show promise in treating both acute COVID infections and long COVID in this manner. Preliminary in vitro data demonstrated the drug’s ability to slow or halt the progression of SARS-CoV-2 (the virus that causes COVID-19) in human lung cells.

STAT-205 for acute COVID is currently being evaluated in a Phase 1 clinical trial in adult patients with mild COVID-19 who are at high risk of disease progression. The randomized, single-blind, placebo-controlled study is halfway through its enrollment of 24 patients.

Most people with COVID-19 recover within weeks of contracting the infection; however, a significant number experience acute infection with symptoms lingering longer than four weeks. The condition is known as long-haulers syndrome or long COVID, and studies indicate that up to 43 percent of people infected with COVID-19 globally will experience these symptoms.¹

Long COVID symptoms can include extreme fatigue that interferes with activities of daily living as well as headache, brain fog, shortness of breath, and skin manifestations. The condition can affect anyone regardless of age, health status or severity of their COVID-19 infection. The physical, mental and economic tolls are significant. Persistent fatigue following COVID-19 is one of the most common symptoms, and no standard of care for PASC exists. For these reasons, new therapies are urgently needed.

About Statera Biopharma, Inc.
Statera Biopharma, Inc. (formerly Cytocom, Inc.) is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the body’s immune system and restore homeostasis. Statera has a large platform of toll-like receptor (TLR) agonists with TLR4 and TLR9 antagonists, and the TLR5 agonists, Entolimod and GP532. TLRs are a class of protein that plays a key role in the innate immune system. Statera is developing therapies designed to directly elicit within patients a robust and durable response of antigen-specific killer T-cells and antibodies, thereby activating essential immune defenses against autoimmune, inflammatory, infectious diseases, and cancers. Statera has clinical programs for Crohn’s disease (STAT-201), hematology (Entolimod), pancreatic cancer (STAT-401) and COVID-19 (STAT-205) in addition to potential expansion into fibromyalgia and multiple sclerosis. To learn more about Statera, please visit www.staterabiopharma.com.

Forward Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties. All statements other than statements of current or historical fact contained in this press release, including statements regarding the Company’s expected clinical development timeline for the Company’s product candidates, future financial position, business strategy, new products, budgets, liquidity, cash flows, projected costs, regulatory approvals, the impact of any laws or regulations applicable to the Company, and plans and objectives of management for future operations, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “should,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “will,” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements on the current expectations about future events held by management. While we believe these expectations are reasonable, such forward-looking statements are inherently subject to risks and uncertainties, many of which are beyond the Company’s control. The Company’s actual future results may differ materially from those discussed here for various reasons. The Company discusses many of these risks under the heading “Risk Factors” in the proxy statement/prospectus filed with the SEC on June 10, 2021, as updated by the Company’s other filings with the SEC.

Given these uncertainties, you should not place undue reliance on these forward-looking statements. The forward-looking statements included in this press release are made only as of the date hereof. We do not undertake any obligation to update any such statements or to publicly announce the results of any revisions to any of such statements to reflect future events or developments.

References

¹Chen C, Haupert S, Zimmermann L, et al. Global Prevalence of Post-Acute Sequelae of COVID-19 (PASC) or Long COVID: A Meta-Analysis and Systematic Review. medRxiv 2021.11.15.21266377; doi: https://doi.org/10.1101/2021.11.15.21266377

Contacts:

Statera Biopharma
Nichol Ochsner
Executive V.P. Investor Relations and Corporate Communications
(732) 754-2545
nichol.ochsner@staterabiopharma.com
    
FINN Partners
Glenn Silver (Media)
(973) 818-8198
glenn.silver@finnpartners.com

FINN Partners
David Carey (IR)
(212) 867-1768
David.carey@finnpartners.com