ReAlta Life Sciences has dosed the first subjects in the Phase Ib Inhaled- lipopolysaccharide (LPS) challenge clinical trial of RLS-0071 in healthy participants to potentially treat severe asthma.
RLS-0071 can specifically hinder various inflammatory pathways.
This dual-action complement inhibitor and innate anti-inflammatory peptide is being developed to treat hypoxic ischemic encephalopathy, severe asthma and various other rare ailments.
The randomised, placebo-controlled, double-blind, proof of mechanism and dose range finding trial will evaluate the safety, tolerability and pharmacodynamics including variation in the count of sputum neutrophils and neutrophil effectors of RLS-0071.
It will enrol 48 healthy adults who will be challenged with inhaled LPS.
On inhaling, LPS induces neutrophilic lung disease temporarily, which has a phenotype and mechanism similar to severe asthma.
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The company is carrying out the trial in partnership with the Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM), in Hannover, Germany.
ReAlta chief medical officer Kenji Cunnion said: “RLS-0071’s dual anti-inflammatory mechanism of action has potential utility across many inflammatory conditions.
“We have already shown that RLS-0071 was well tolerated and demonstrated target engagement in Phase 1 clinical trial in healthy volunteers.
“This study will inform development plans for RLS-0071 in severe asthma and related pulmonary programmes, as well as other programmes in neurology, including hypoxic-ischemic encephalopathy.”
In March this year, the company received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to commence a Phase II clinical trial of RLS-0071 for treating hypoxic-ischemic encephalopathy (HIE) in neonates.
The two-stage, double-blind, randomised, placebo-controlled, multiple ascending dose trial was designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of RLS-0071 to treat moderate or severe HIE in new-borns who are undergoing hypothermia treatment.