Statera Biopharma Submits Phase 3 Clinical Trial Protocol to FDA for Investigational Treatment of Pediatric Crohn’s Disease

Rhea-AI Summary

Statera Biopharma (Nasdaq: STAB) has submitted its Phase 3 clinical trial protocol for STAT-201 to the FDA aimed at treating pediatric patients with Crohn's Disease. This milestone highlights the potential of STAT-201 to address debilitating symptoms in children, including growth failure and malnutrition. The trial will assess the drug's safety and efficacy in 12 to 17-year-olds, with enrollment expected in early 2022. Previous Phase 2 results indicated a 67% remission rate and no serious adverse events, alongside orphan drug designation from the FDA.

Positive

• Submission of Phase 3 clinical trial protocol for STAT-201 is a critical milestone.
• Previous Phase 2 study showed a 67% remission rate and no serious adverse events.
• FDA orphan drug designation for STAT-201 enhances its development prospects.

Negative

• None.

Company developing STAT-201 as a novel therapy for immune modulation in treating pediatric patients with Crohn’s Disease

FORT COLLINS, Colo., Dec. 29, 2021 (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 Phase 3 clinical trial protocol for STAT-201 in the treatment of pediatric Crohn’s Disease (CD).

“Submitting our Phase 3 clinical trial protocol is a critical milestone in our development program,” said Michael K. Handley, President and Chief Executive Officer, Statera Biopharma. “In addition to the common GI symptoms, children with Crohn’s Disease often experience growth failure, malnutrition, delayed puberty, and bone demineralization. STAT-201 has the potential to provide great physical and emotional relief to adolescents who live with Crohn’s Disease.”

The Phase 3, multicenter, randomized clinical trial, A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety, of STAT-201 in Pediatric Patients Aged 12 to 17 Years (Inclusive) with Active Crohn's Disease, will evaluate the safety and efficacy of STAT-201 compared to placebo in establishing remission in pediatric CD patients. The trial sites are currently being selected and enrollment is expected to launch in early 2022.

CD is a chronic relapsing inflammatory condition of the gastrointestinal (digestive) tract, causing symptoms such as persistent diarrhea, abdominal pain, and rectal bleeding. Once considered rare in the pediatric population, it is currently recognized as one of the most important chronic diseases that affect children and adolescents. Approximately 20-30% of all patients with CD present when they are younger than 20 years of age. The signs and symptoms are unpredictable, resulting in physical, emotional, and economic burdens. CD continues to impose significant burdens on patients, despite current treatments, patients continue to have disease flares, smoldering disease, or experience intolerable side effects and new treatment options are needed. ¹

STAT-201, Statera’s most advanced drug candidate, is an immune modulator focused on the restoration of mucosal healing and intestinal barrier function as an adjunct to the standard of care in moderate to severe CD. A Phase 2 study demonstrated proof of concept and safety as well as remission in 67% of participants and 43% of true mucosal healing with endoscopies. No serious adverse events were reported in the trial. STAT-201 also has received FDA orphan drug designation for the treatment of CD in pediatric patients.

About Statera Biopharma
Statera Biopharma (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 one of the largest platforms of toll-like receptor (TLR) agonists in the biopharmaceutical industry 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 or preclinical 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 Biopharma, 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. Factors that may cause such differences include, but are not limited to, the outcome of any legal proceedings that have been or may be instituted against the company related to the merger between Cleveland BioLabs and Cytocom; unexpected costs, charges or expenses resulting from the merger; the Company's need for additional financing to meet the Company's business objectives; the Company's history of operating losses; the Company's ability to successfully develop, obtain regulatory approval for, and commercialize the Company's products in a timely manner; the Company's plans to research, develop and commercialize the Company's product candidates; the Company's ability to attract collaborators with development, regulatory and commercialization expertise; the Company's plans and expectations with respect to future clinical trials and commercial scale-up activities; the Company's reliance on third-party manufacturers of the Company's product candidates; the size and growth potential of the markets for the Company's product candidates, and the Company's ability to serve those markets; the rate and degree of market acceptance of the Company's product candidates; regulatory requirements and developments in the United States, the European Union and foreign countries; the performance of the Company's third-party suppliers and manufacturers; the success of competing therapies that are or may become available; the Company's ability to attract and retain key scientific or management personnel; the Company's historical reliance on government funding for a significant portion of the Company's operating costs and expenses; government contracting processes and requirements; the exercise of significant influence over the Company's company by the Company's largest individual stockholder; the impact of the novel coronavirus ("COVID-19") pandemic on the Company's business, operations and clinical development; the geopolitical relationship between the United States and the Russian Federation as well as general business, legal, financial and other conditions within the Russian Federation; the Company's ability to obtain and maintain intellectual property protection for the Company's product candidates; the Company's potential vulnerability to cybersecurity breaches; and other factors discussed in the Company's SEC filings, including the Company's Annual Report on Form 10-K for the year ended December 31, 2020 and the risk factors discussed under the heading "Risk Factors" in the proxy statement/prospectus the company filed in connection with the merger on June 10, 2021. 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.

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

References

¹ Medscape, Pediatric Crohn’s Disease, Andrew B. Grossman, MD; Carmen Cuffari, MD

FAQ

What is the goal of the Phase 3 trial for STAT-201?

The Phase 3 trial aims to evaluate the safety and efficacy of STAT-201 in establishing remission in pediatric patients aged 12 to 17 with active Crohn's Disease.

When is the enrollment for the STAT-201 trial expected to begin?

Enrollment for the trial is expected to begin in early 2022.

What were the results of the previous Phase 2 trial for STAT-201?

The Phase 2 trial showed a 67% remission rate and 43% of participants achieving true mucosal healing, with no serious adverse events reported.

What is Crohn's Disease and its impact on children?

Crohn's Disease is a chronic inflammatory condition that affects the gastrointestinal tract, often leading to significant physical and emotional burdens in pediatric patients.

What regulatory designation did STAT-201 receive from the FDA?

STAT-201 has received FDA orphan drug designation for the treatment of Crohn's Disease in pediatric patients.