ReAlta Life Sciences, Inc., a clinical-stage biotech company dedicated to saving lives by rebalancing the inflammatory response to address rare and acute inflammatory diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation and Fast Track Designation to RLS-0071, the Company’s lead therapeutic candidate, for the treatment of hospitalized patients with steroid-refractory acute graft-versus-host disease (aGvHD).
aGvHD is a serious and often fatal complication following hematopoietic stem cell transplantation. It occurs when the donor’s immune cells attack the recipient’s tissues, leading to severe inflammation and tissue damage. Patients who do not respond to standard steroid treatments have limited therapeutic options and face a high risk of mortality. There are approximately 4,000 steroid-refractory aGvHD patients in the U.S., EU and Japan.
RLS-0071, an investigational medicine based on the Company’s novel EPICC peptide platform, aims to address this unmet medical need by leveraging its unique ability to modulate the complement and innate inflammatory pathways, offering a new hope for patients with this devastating condition. The Company is currently conducting a Phase 2, open label clinical trial of RLS-0071 in hospitalized patients with steroid-refractory aGvHD. For further details on this trial, please visit clinicaltrials.gov (NCT06343792).
“We are thrilled to receive both Orphan Drug and Fast Track Designations for RLS-0071 for the treatment of steroid-refractory acute graft-versus-host disease, underscoring the significant potential of RLS-0071 and its novel dual mechanism-of-action to address critical unmet needs for patients with this life-threatening condition,” said Kenji Cunnion, MD, MPH, Chief Medical Officer of ReAlta. “RLS-0071 may address limitations of current treatment options for patients with aGvHD. We remain committed to advancing our clinical development program with the hope of bringing this promising therapy to patients as quickly as possible.”
The FDA’s Orphan Drug Designation is granted to investigational therapies intended for the treatment of rare diseases or conditions that affect fewer than 200,000 people in the United States. This designation provides ReAlta with certain benefits, including seven years of market exclusivity upon regulatory approval, exemption from FDA application fees, and tax credits for qualified clinical trials.
In addition to the Orphan Drug Designation, RLS-0071 has also received FDA Fast Track Designation for the treatment of aGvHD. Fast Track is a process designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. This designation allows for more frequent interactions with the FDA and the potential for Priority Review, ultimately accelerating the timeline for bringing RLS-0071 to patients in need.
The Company is also currently conducting Phase 2 clinical trials of RLS-0071 in newborns with hypoxic ischemic encephalopathy (HIE) (NCT05778188) and hospitalized patients with acute exacerbations of chronic obstructive pulmonary disease (NCT06175065).