NORFOLK, Va.– 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.
