ReAlta Life Sciences Begins Phase 2 Trial for RLS-0071 in Steroid-Refractory Acute Graft-versus-Host Disease

ReAlta Life Sciences, Inc., a clinically focused biopharmaceutical company, has initiated the dosing of the first patient in its Phase 2 trial of RLS-0071. This lead therapeutic candidate aims to treat patients hospitalized with moderate to very severe steroid-refractory acute graft-versus-host disease (aGvHD). This condition, arising post hematopoietic stem cell transplantation, can be severe and often fatal due to the donor immune cells attacking the host's body, causing intense inflammation and tissue damage.

Dr. Kenji Cunnion, the Chief Medical Officer of ReAlta, emphasized the critical nature of hematopoietic stem cell transplantation in treating cancer, autoimmune diseases, sickle cell disease, and other life-threatening conditions. However, the onset of aGvHD poses a significant risk, turning the life-saving procedure into a life-threatening complication. Dr. Cunnion believes that RLS-0071 holds promise as a potent solution to improve outcomes for those grappling with this serious condition. The therapeutic candidate's dual mechanism-of-action (MOA) is designed to mitigate undesirable inflammatory responses from donor cells. The company is committed to progressing this clinical program to aid patients dealing with steroid-refractory aGvHD.

Patients with aGvHD who are not responsive to standard steroid treatment face limited options, severe inflammation, tissue damage, and a high mortality risk. Annually, around 4,000 patients in the US, EU, and Japan develop steroid-refractory aGvHD. RLS-0071, an investigational drug from ReAlta's novel EPICC peptide platform, aims to address this unmet medical need. The drug utilizes a unique dual-targeting MOA to influence both the complement and innate inflammatory pathways, potentially offering new hope for patients. The U.S. Food and Drug Administration (FDA) has granted RLS-0071 Orphan Drug Designation and Fast Track Designation for treating steroid-refractory aGvHD.

ReAlta is also conducting Phase 2 trials of RLS-0071 for other conditions, including hypoxic ischemic encephalopathy (HIE) in newborns and acute exacerbations of chronic obstructive pulmonary disease (AE-COPD).

The Phase 2 study, identified as NCT06343792, is an open-label, prospective, dose-escalation trial designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, dosing, and efficacy of RLS-0071 as a secondary treatment for aGvHD in hospitalized patients who are unresponsive to steroids. Participants will receive assigned doses of RLS-0071 for 7 or 14 days either as monotherapy or in combination with the standard treatment, ruxolitinib. The primary outcome measures include safety and overall response rate.

ReAlta Life Sciences, founded in 2018, is based in Norfolk, Virginia, and Aguadilla, Puerto Rico. The company's EPICC peptide platform is derived from discoveries related to the human astrovirus, HAstV-1, which uniquely inhibits components of the innate immune system, preventing inflammation. This platform leverages these mechanisms to develop therapies that modulate complement and innate inflammatory pathways. The company’s lead candidate, RLS-0071, has received multiple designations from the FDA and European Medicines Agency for various conditions, including HIE and aGvHD, and has an investigational new drug (IND) clearance for treating AE-COPD.