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German BfArM Approves ReAlta Life Science’s Phase 1b Inhaled LPS Challenge Trial to Support Development of RLS-0071 in Severe Asthma

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

NORFOLK, Virginia, May 10, 2022–(BUSINESS WIRE)–ReAlta Life Sciences (“ReAlta”), Inc., a clinical-stage rare disease company dedicated to harnessing the power of the immune system to fight life-threatening diseases, announced today that the company had obtained regulatory approval from the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) to conduct a Phase 1b clinical trial of inhaled lipopolysaccharides (LPS) in healthy volunteers to support the 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 for the treatment of hypoxic ischemic encephalopathy, severe asthma and other rare diseases.

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

The clinical trial is a phase 1b, randomized, double-blind, placebo-controlled, dose-finding study to assess safety, tolerability and pharmacodynamics, including change in sputum neutrophil count 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 phenotype and mechanism similar to severe asthma. The trial is being conducted in collaboration with the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), Hannover, Germany. More information about the trial can be found at clinicaltrials.gov (NCT#05351671).

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

About ReAlta Life Sciences
ReAlta Life Sciences, Inc. is a clinical-stage rare disease biotechnology company dedicated to harnessing the power of the immune system to fight life-threatening diseases. The Company’s EPICC peptides are based on research on 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 take advantage of 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 from the U.S. Food and Drug Administration and European Medicines Agency for the treatment of encephalopathy hypoxic-ischemic (HIE) in neonates. The company was launched in 2018 and is located in Norfolk, Virginia. For more information, please visit www.realtalifesciences.com.

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