ReAlta Life Sciences Announces Proof of Mechanism Data from the Phase 1b Inhaled LPS Trial of RLS-0071, Demonstrating Powerful Inhibition of Lung Neutrophils and Inflammatory Cytokines

NORFOLK, Va.–(BUSINESS WIRE)–ReAlta Life Sciences (“ReAlta”), Inc., a company addressing life-threatening rare diseases through harnessing the power of the immune system, today announced exciting new proof-of-mechanism data from the company’s Phase 1b Inhaled LPS clinical trial of RLS-0071 presented at the American Thoracic Society International Conference on May 23, 2023. RLS-0071 is the Company’s lead dual action complement inhibitor and innate anti-inflammatory peptide in development as a treatment for HIE and other rare diseases.

“We are excited to share these new data from our Phase 1b trial, which clearly demonstrates the ability of RLS-0071 to dramatically inhibit neutrophil infiltration and pro-inflammatory cytokines such as IL-1ß and IL-8 in a human model of LPS-initiated acute lung disease,” said Ulrich Thienel, Ph.D., MD, chief executive officer of ReAlta. “The clear translatability of our mechanisms of action from preclinical models to humans encourages our efforts to explore RLS-0071 as a potential therapy for acute pulmonary diseases and other neutrophil-mediated disease processes.”

Findings from the Phase 1b Inhaled LPS trial demonstrated that treatment with RLS-0071 was safe and well-tolerated. Thirty subjects were randomized into three cohorts (10 subjects per cohort) that first inhaled lipopolysaccharide (LPS) and then received three administrations of RLS-0071 at 10 mg/kg (low dose), a 120 mg/kg loading dose followed by two administrations of 40 mg/kg (high dose) or placebo at 1 hour, 8 hours and 16 hours timepoints after the initial LPS inhalation. Blood and sputum were collected for analysis at 6-hour and 24-hour timepoints. Data presented at the American Thoracic Society (ATS) showed that:

• RLS-0071 strongly inhibited neutrophil migration into the lungs by 50%

• RLS-0071 showed statistically significant reductions in sputum neutrophils, sputum myeloperoxidase (MPO), sputum neutrophil elastase levels and NETosis markers

• RLS-0071 also showed clear, meaningful reductions in IL- 1ß and IL-8 pro-inflammatory cytokines

The poster presentation given at ATS by Prof. Dr. Jens M. Hohlfeld, Division Director of Airway Research at the Fraunhofer Institute for Toxicology and Experimental Medicine in Hannover, Germany and lead investigator for the study can be downloaded from the Our Science section of the ReAlta website. Based on the data from the Phase 1b Inhaled LPS trial, ReAlta plans further development in neutrophil-mediated pulmonary disease indications.

About ReAlta Life Sciences

ReAlta Life Sciences, Inc. is a mid-stage clinical biotech company dedicated to harnessing the power of the immune system to address life threatening rare diseases. The Company’s EPICC peptides are based on research into the human astrovirus, HAstV-1, which causes a non-inflammatory, self-limiting gastroenteritis unique among viruses by inhibiting components of the innate immune system. ReAlta’s therapeutic peptides leverage these virus-derived mechanisms to rebalance complement and inflammatory processes in the body. The company’s pipeline is led by RLS-0071, which has received IND clearance, and Orphan Drug Designation by the U.S. Food and Drug Administration and European Medicines Agency, and Fast Track Designation for the treatment of hypoxic-ischemic encephalopathy (HIE) in neonates. The company launched in 2018 and is located in Norfolk, Virginia. For more information, please visit www.realtalifesciences.com.

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