ReAlta Life Sciences has announced the dosing of the first patient in its Phase 2 clinical trial evaluating RLS-0071 for the treatment of steroid-refractory acute graft-versus-host disease (aGvHD). This study marks a significant step forward in addressing a critical unmet need for patients who do not respond to standard steroid treatments and face a high risk of mortality.
Addressing Steroid-Refractory aGvHD
Acute graft-versus-host disease is a severe complication following hematopoietic stem cell transplantation, where transplanted immune cells attack the patient's tissues, leading to inflammation and tissue damage. Approximately 4,000 patients in the U.S., EU, and Japan develop steroid-refractory aGvHD annually, highlighting the urgent need for effective alternative therapies.
RLS-0071: A Novel Therapeutic Approach
RLS-0071 is an investigational medicine based on ReAlta's EPICC peptide platform. It features a dual-targeting mechanism of action designed to modulate both the complement and innate inflammatory pathways. This unique approach offers a potential new treatment option for patients with steroid-refractory aGvHD.
Kenji Cunnion, MD, MPH, Chief Medical Officer of ReAlta, stated, "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 (MOA) to inhibit unwanted inflammatory side-effects from the donor cells. We are committed to advancing this clinical program on behalf of patients facing steroid-refractory aGvHD."
Study Design and Objectives
The Phase 2 study (NCT06343792) is an open-label, prospective, dose-escalation trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, dosing, and efficacy of RLS-0071. Hospitalized patients with steroid-refractory aGvHD will receive RLS-0071 at assigned dose levels for 7 or 14 days, either as a monotherapy or in combination with ruxolitinib, a standard-of-care treatment. The primary outcome measures include safety and overall response rate.
Regulatory Designations
The U.S. Food and Drug Administration (FDA) has granted RLS-0071 both Orphan Drug Designation and Fast Track Designation for the treatment of steroid-refractory aGvHD. These designations underscore the potential of RLS-0071 to address a significant unmet medical need in a serious and life-threatening condition.
Expanding Clinical Pipeline
ReAlta Life Sciences is also conducting Phase 2 clinical trials of RLS-0071 in newborns with hypoxic ischemic encephalopathy (HIE) and in hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease (AE-COPD), further demonstrating the broad potential of the EPICC peptide platform.
