Statera Biopharma, Inc., Announces Central Institutional Review Board Approval of Phase 3 Clinical Trial for Pediatric Crohn’s Disease

Rhea-AI Summary

Statera Biopharma announced that it has received approval from the Central Institutional Review Board to conduct a Phase 3 clinical trial for its drug STAT-201, aimed at treating pediatric Crohn’s Disease. The trial, set to begin in Q2 2022, will assess the safety and efficacy of STAT-201 in patients aged 12 to 17, with around 165 participants expected. Previous Phase 2 results showed a 67% remission rate without serious adverse events. The FDA has granted STAT-201 orphan drug designation for treating Crohn’s in pediatric patients, highlighting its potential in a growing patient demographic.

Positive

• IRB approval for Phase 3 trial of STAT-201 enhances potential for treating pediatric Crohn's Disease.
• Phase 2 study showed 67% remission rate with no serious adverse events reported.
• STAT-201 has received FDA orphan drug designation for pediatric Crohn's, indicating potential market advantages.

Negative

• None.

STAT-201 is being developed as a novel, immune-modulation therapy for treating Crohn’s Disease

Phase 3 trial expected to begin in second quarter 2022

FORT COLLINS, Colo., Feb. 15, 2022 (GLOBE NEWSWIRE) -- Statera Biopharma, Inc. (Nasdaq: STAB), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, announced today that it has received Central Institutional Review Board (IRB) approval to conduct a Phase 3 clinical trial for STAT-201 in the treatment of pediatric Crohn’s Disease (CD), a chronic relapsing inflammatory condition of the gastrointestinal tract.

“IRB approval to proceed with our Phase 3 trial is an important step for the development of STAT-201, one that potentially may lead to better treatment for pediatric patients whose lives are significantly impacted by the physical and emotional burdens of CD,” said Michael Handley, President and CEO of Statera Biopharma. “STAT-201, our most advanced drug candidate, is an immune modulator that can provide for the restoration of mucosal healing and intestinal barrier function as an adjunct to standard of care in CD.”

The 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 with Active Crohn’s Disease, will evaluate the safety and efficacy of STAT-201 compared to placebo in establishing remission in pediatric CD patients. Approximately 165 participants will be randomized between the three treatment arms. Trial sites are being selected, and patient enrollment is expected to begin during the second quarter.

In a Phase 2 study, STAT-201 demonstrated safety as well as remission in 67% of participants and 43% mucosal healing as measured by endoscopic assessment. No serious adverse events were reported in the trial. STAT-201 has received FDA orphan drug designation for treatment of CD in pediatric patients.

CD is now recognized as one of the most prevalent chronic diseases in children and adolescents. Approximately 20-30% of all CD patients present symptoms when they are younger than age 20 including persistent diarrhea, abdominal pain and rectal bleeding. Due to the unpredictable nature of the disease, patients endure significant physical, emotional and economic burdens. Despite current treatments, CD patients continue to have disease flares, smoldering disease or intolerable side effects, making the need for new therapy approaches critical.

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.

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

FAQ

What is the purpose 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 with Crohn's Disease.

When is the expected start date for the trial of STAT-201?

The Phase 3 trial for STAT-201 is expected to begin in the second quarter of 2022.

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

In the Phase 2 study, STAT-201 demonstrated a 67% remission rate and 43% mucosal healing, with no serious adverse events reported.

What is the significance of the FDA orphan drug designation for STAT-201?

The FDA orphan drug designation for STAT-201 highlights its potential to address an unmet medical need in treating pediatric Crohn's Disease.

How many participants are expected in the Phase 3 trial for STAT-201?

Approximately 165 participants will be randomized in the Phase 3 trial for STAT-201.