Participants in the trial will receive RLS-0071 for seven or 14 days, either as a standalone therapy or in combination with ruxolitinib. Credit: Pormezz / Shutterstock.

US-based biopharmaceutical company ReAlta Life Sciences has dosed the first subject in its Phase II clinical trial of RLS-0071 for treating steroid-refractory acute graft-versus-host disease (aGvHD).

The open-label, dose-escalation study will assess the tolerability, safety, pharmacokinetics, pharmacodynamics, dosing and efficacy of RLS-0071 as a secondary treatment for aGvHD in patients who do not respond to steroid therapy.

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Participants in the trial will receive RLS-0071 for seven or 14 days, either as a standalone therapy or in combination with the standard treatment ruxolitinib.

The study’s primary goals are to evaluate the safety and overall response rate in patients given RLS-0071.

RLS-0071 is an investigational therapeutic candidate based on ReAlta’s EPICC peptide platform, designed with a dual-targeting mechanism to modulate both complement and innate inflammatory pathways.

The US Food and Drug Administration (FDA) recently granted orphan drug and fast track designations to RLS-0071 for treating steroid-refractory aGvHD.

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ReAlta Life Sciences chief medical officer Kenji Cunnion said: “Haematopoietic stem cell transplantation is one of the most impactful treatments available for people with cancer, autoimmune disease, sickle cell disease and other life-threatening disorders.

“However, the procedure can quickly turn into a severe and life-threatening condition for those who are affected by acute graft-versus-host disease in which the transplanted immune cells attack the patient, leading to severe inflammation and tissue damage.

“We believe that RLS-0071 has the potential to be a powerful new tool to improve outcomes for individuals with this serious complication of transplantation.

“We aim to leverage RLS-0071’s unique dual mechanism-of-action to inhibit unwanted inflammatory side-effects from the donor cells.”

ReAlta is also carrying out Phase II trials of RLS-0071 for newborns with hypoxic-ischaemic encephalopathy and for patients hospitalised with acute exacerbations of chronic obstructive pulmonary disease.

The company was founded in 2018 and has operations in Norfolk, Virginia; and Aguadilla, Puerto Rico.