FDA Grants ReAlta Life Sciences Orphan and Fast Track Designation for RLS-0071 in Steroid-Refractory Acute Graft-versus-Host Disease Treatment

ReAlta Life Sciences, Inc. ("ReAlta"), a clinical-stage biotechnology company, is focused on addressing rare and acute inflammatory diseases by rebalancing the body's inflammatory response. Recently, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation and Fast Track Designation to ReAlta’s lead therapeutic candidate, RLS-0071, for treating hospitalized patients with steroid-refractory acute graft-versus-host disease (aGvHD).

Acute graft-versus-host disease (aGvHD) is a severe and often life-threatening complication that can occur post-hematopoietic stem cell transplantation. This condition arises when the donor's immune cells begin to attack the recipient's tissues, causing significant inflammation and damage. For patients who do not respond to standard steroid treatments, there are limited therapeutic options available, resulting in a high mortality risk. In the U.S., EU, and Japan, there are approximately 4,000 patients with steroid-refractory aGvHD.

RLS-0071 is an investigational drug developed from ReAlta’s EPICC peptide platform. This platform uniquely modulates both complement and innate inflammatory pathways, providing new therapeutic possibilities for patients suffering from aGvHD. ReAlta is currently undertaking a Phase 2 open-label clinical trial of RLS-0071 in hospitalized patients with steroid-refractory aGvHD. Detailed information about this trial can be found at clinicaltrials.gov under the identifier NCT06343792.

Kenji Cunnion, MD, MPH, Chief Medical Officer of ReAlta, expressed the company's enthusiasm about receiving both Orphan Drug and Fast Track Designations for RLS-0071. He highlighted that the drug's dual mechanism-of-action has the potential to meet critical unmet needs for patients with this severe condition. He emphasized the company's commitment to advancing the clinical development of RLS-0071 to bring this promising therapy to patients as soon as possible.

The FDA's Orphan Drug Designation is awarded to investigational therapies aimed at treating rare diseases or conditions affecting fewer than 200,000 people in the United States. This designation provides ReAlta with various benefits, including seven years of market exclusivity upon regulatory approval, exemption from FDA application fees, and tax credits for qualified clinical trials.

Furthermore, the Fast Track Designation is designed to expedite the development and review process of drugs targeting serious conditions and addressing unmet medical needs. This designation allows for more frequent interactions with the FDA and the possibility of Priority Review, which could accelerate the timeline for bringing RLS-0071 to patients who need it most.

In addition to its work on aGvHD, ReAlta is conducting Phase 2 clinical trials of RLS-0071 for other conditions. These include newborns with hypoxic-ischemic encephalopathy (HIE) under clinical trial identifier NCT05778188 and hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease under identifier NCT06175065.

ReAlta Life Sciences, Inc. is dedicated to saving lives by rebalancing the inflammatory response in acute inflammatory and rare diseases. Their EPICC peptides are grounded in research on the human astrovirus HAstV-1, which uniquely causes non-inflammatory, self-limiting gastroenteritis by inhibiting components of the innate immune system. By leveraging these virus-derived mechanisms, ReAlta’s therapeutic peptides aim to rebalance complement and inflammatory processes. The company's pipeline includes RLS-0071, which has achieved several regulatory milestones, including IND clearance and various designations by the FDA. Founded in 2018, ReAlta operates from Norfolk, Virginia, and Aguadilla, Puerto Rico.