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Germany’s BfArM Approves ReAlta Life Sciences’ Phase 1b Study

Inhaled LPS Challenge Trial to Support Development of RLS-0071 in Severe Asthma

RLS-0071 is ReAlta’s lead dual action complement inhibitor and innate anti-inflammatory peptide in development as a treatment for hypoxic ischemic encephalopathy, severe asthma, and other rare diseases

Norfolk, VA, – ReAlta Life Sciences (“ReAlta”), Inc., a clinical stage, rare disease company dedicated to harnessing the power of the immune system to address life threatening diseases, today announced the company secured regulatory approval from Germany’s Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) to conduct a Phase 1b inhaled lipopolysaccharide (LPS) challenge clinical trial in healthy volunteers to support development of the Company’s lead compound, RLS-0071, in severe asthma. RLS-0071 is the Company’s lead dual action complement inhibitor and innate anti-inflammatory peptide in development as a treatment for hypoxic ischemic encephalopathy, severe asthma, and other rare diseases.

“Severe asthma, characterized by asthmatics who fail standard of care therapies including biologics, is a drastic unmet medical need.” said Ulrich Thienel, M.D., Ph.D., ReAlta’s Chief Executive Officer. “New treatment approaches are needed for this rare subset of asthma, given the lack of therapeutic options for these patients. In our preclinical rat model, RLS-0071 demonstrated a striking decrease of neutrophil infiltration and tissue damage after just a single IV injection. Results from this Phase 1b trial in healthy volunteers with LPS will further support RLS-0071’s dual-action mechanism in a target patient population, and additional regulatory and clinical steps.”

The clinical trial is a Phase 1b, randomized, double-blind, placebo-controlled, dose range finding study to assess the safety, tolerability and pharmacodynamics including change in count of sputum neutrophils and neutrophil effectors of RLS-0071 in 48 healthy adult subjects after challenge with inhaled LPS. When inhaled, LPS temporarily induces neutrophilic lung disease, creating a similar phenotype and mechanism to severe asthma. The trial is being run in collaboration with the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), in Hannover, Germany. More information about the trial can be found at clinicaltrials.gov (NCT # 05351671).

RLS-0071 is a 15 amino acid peptide that both inhibits humoral inflammation by blocking classical pathway complement activation and cellular inflammation by blocking the neutrophil effectors myeloperoxidase (MPO) and neutrophil extracellular traps (NETs).

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