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June 2, 2022

ReAlta doses first subjects in Phase Ib severe asthma therapy trial

The trial will evaluate the safety, tolerability and pharmacodynamics of RLS-0071 in healthy subjects.

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. 

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. 

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