FDA Approves Phase 2 Trial of RLS-0071 in Hospitalized Patients With Steroid-refractory Acute Graft-versus-host Disease by Realta Life Sciences
Thursday, September 07, 2023
ReAlta Life Sciences, Inc., known as ReAlta, is a clinical-stage biotechnology company that focuses on harnessing the immune system's potential to combat life-threatening diseases. Recently, they announced the clearance of their Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical trial of RLS-0071. This trial aims to assess its efficacy in hospitalized patients who suffer from steroid-refractory acute graft-versus-host disease (aGvHD). RLS-0071, the company's leading dual-action complement and innate inflammatory inhibitor peptide, is currently under development for aGvHD, hypoxic-ischemic encephalopathy (HIE), and other rare and acute inflammatory diseases.
ReAlta's CEO, Dr. Ulrich Thienel, explained that steroid-refractory aGvHD is driven by processes like endothelial injury, neutrophil recruitment and activation, NETosis, and complement activation. These underlying mechanisms have devastating consequences for patients, necessitating innovative treatments. Dr. Thienel expressed confidence in RLS-0071's potential to address this unmet medical need. The FDA's clearance marks a significant milestone in ReAlta's journey as they explore the therapeutic potential of RLS-0071 across multiple indications.
The Phase 2 clinical trial will be an open-label study with both dose-ranging and escalation and expansion cohorts. It will evaluate various aspects of RLS-0071, including safety, tolerability, pharmacokinetics, pharmacodynamics, dosing, and efficacy in hospitalized patients with steroid-refractory aGvHD. Patients will be randomized to receive ascending doses of RLS-0071 either in combination with ruxolitinib (the current standard of care) or as a standalone treatment. The trial will be conducted at multiple transplant medical centers across the United States and Europe.
The primary endpoints of the study are to assess the safety of RLS-0071 and determine its overall response rate at 28 days. Key secondary endpoints include evaluating clinical responses by organ system, studying pharmacokinetics, and analyzing biomarkers related to organ injury and inflammation.
Acute GvHD is a complication that can occur in patients who have undergone bone marrow or stem cell transplants. In this condition, the donor cells from the transplant attack the recipient's body as if it were foreign, leading to a range of health problems, from skin issues to severe complications and, in some cases, fatalities, as the donor cells attempt to adapt to the recipient's body.
