NORFOLK, Va .--(BUSINESS WIRE)--ReAlta Life Sciences, Inc. (“ReAlta” or the “Company”), a clinical mid-stage biotech company focused on harnessing the power of the immune system to address life-threatening diseases, today announced U.S. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for a Phase 2 clinical trial of RLS-0071 in hospitalized patients with steroid-refractory acute graft-versus-host disease (aGvHD). RLS-0071 is the Company’s lead dual-action complement and innate inflammatory inhibitor peptide in development for aGvHD, hypoxic-ischemic encephalopathy (HIE), and other rare and acute inflammatory diseases.
“In steroid-refractory patients, acute Graft-versus-Host Disease is driven by endothelial injury followed by neutrophil recruitment and activation, NETosis and complement activation. This underlying pathogenesis has a devastating impact on patients with steroid-refractory acute GvHD and calls for innovative and effective treatments. We believe RLS-0071 has the potential to fill this unmet need given its dual-targeting and rapid mechanism of action,” said ReAlta Chief Executive Officer Ulrich Thienel, MD, PhD. “This FDA clearance marks an important new milestone for ReAlta as we explore the potential of RLS-0071 across multiple indications."
The Phase 2 clinical trial will be an open label, prospective dose-ranging study with escalation and expansion cohorts to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, dosing and efficacy in hospitalized patients with steroid-refractory acute Graft-versus-Host Disease. Patients will receive either ascending doses of RLS-0071 with concurrent ruxolitinib (current standard of care) or RLS-0071 without ruxolitinib. The study will be conducted at multiple transplant medical centers across the United States and Europe.
The primary endpoints of the study are safety and the overall response rate of RLS-0071 at 28 days. Key secondary endpoints include clinical response by organ system, pharmacokinetics and biomarkers of organ injury and inflammation.
About Acute Graft-versus-Host Disease
Acute GvHD is a subset of GvHD and remains a common complication for patients receiving a bone marrow or stem cell transplant. Acute GvHD occurs when the newly transplanted cells (graft) from the donor attack the recipient's body because they see it as foreign. This can lead to various health problems, from skin rashes to more serious complications, even death, as the donor cells try to implant and adapt to the new environment.
About ReAlta Life Sciences
ReAlta Life Sciences, Inc. is a clinical mid-stage biotech company dedicated to harnessing the power of the immune system to address life threatening acute inflammatory and rare diseases. The Company’s EPICC peptides are based on research into the human astrovirus, HAstV-1, which causes a non-inflammatory, self-limiting gastroenteritis unique among viruses by inhibiting components of the innate immune system. ReAlta’s therapeutic peptides leverage these virus-derived mechanisms to rebalance complement and inflammatory processes in the body. The company’s pipeline is led by RLS-0071, which has received IND clearance by the U.S. Food and Drug Administration (FDA) for the treatment of acute Graft-versus-Host Disease and IND clearance, Orphan Drug Designation, and Fast Track Designation by the FDA, and Orphan Drug Designation by the European Medicines Agency, for the treatment of hypoxic-ischemic encephalopathy (HIE). The company launched in 2018 and is located in Norfolk, Virginia. For more information, please visit www.realtalifesciences.com.