NORFOLK, Va.–(BUSINESS WIRE)–ReAlta Life Sciences, Inc. (“ReAlta”) a clinical stage, rare disease company addressing life-threatening diseases through harnessing the power of the immune system, today announced the dosing of the first patient in its Phase 1b Inhaled- lipopolysaccharide (LPS) challenge clinical trial in healthy volunteers to support development of 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.
“RLS-0071’s dual anti-inflammatory mechanism of action has potential utility across many inflammatory conditions,” said Kenji Cunnion, M.D., M.P.H., Chief Medical Officer of ReAlta. “We have already shown that RLS-0071 was well tolerated and demonstrated target engagement in a Phase 1 clinical trial in healthy volunteers. This study will inform development plans for RLS-0071 in severe asthma and related pulmonary programs, as well as other programs in neurology, including hypoxic-ischemic encephalopathy. We look forward to the readout of the trial.”
The clinical trial is a Phase 1b, randomized, double-blind, placebo-controlled, proof of mechanism, and 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).
About ReAlta
ReAlta Life Sciences, Inc. is a clinical-stage, rare disease biotech company dedicated to harnessing the power of the immune system to address life threatening 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 for the treatment of hypoxic-ischemic encephalopathy (HIE) in neonates. 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). The company launched in 2018 and is located in Norfolk, Virginia. For more information, please visit www.realtalifesciences.com.
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