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The drug is currently undergoing a phase 2 clinical trial for patient 12 years or older who are hospitalized with steroid-refractory acute graft-versus-host disease (aGVHD).
FDA granted RLS-0071 (ReAlta Life Sciences Inc) orphan drug designation and fast track designation for the treatment of patients hospitalized with steroid-refractory acute graft-versus-host disease (aGVHD). The drug is an investigational medicine based on ReAlta Life Sciences’s EPICC peptide platform, with the ability to modulate the complement and innate inflammatory pathways. The drug is also entering a phase 2 open-label clinical trial for this patient population.1
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"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," Kenji Cunnion, MD, MPH, chief medical officer of ReAlta, said in a news release. "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."1
In the phase 2 study, investigators included male and female patient 12 years or older who are hospitalized with steroid-refractory aGVHD after allogenic hematopoietic stem cell transplantation (allo-HSCT). They also have an anticipated hospital stay length of 1 week from the time of treatment initiation. Patients were excluded if they had more than 1 allo-HSCT; current, previous, or planned systemic treatment other than corticosteroids or ruxolitinib for aGVHD; uncontrolled gastrointestinal infection; chronic GVHD; or relapsed primary disease or were treated for relapse after allo-HSCT.1
Title: Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease (AURORA)
ClinicalTrials.gov ID: NCT06343792
Sponsor: ReAlta Life Sciences Inc
Completion Date (Estimated): September 2025
Cohorts included: 10 mg/kg every 8 hours for 7 days; 40mg/kg every 8 hours for 7 days; 10 mg/kg every 8 hours for 14 days with concurrent ruxolitinib; 40 mg/kg every 8 hours for 14 days with concurrent ruxolitinib; 10 mg/kg for 7 days and then 10 mg/kg every 8 hours for 7 days with concurrent ruxolitinib; and 40 mg/kg every 8 hours for 7 days and then 40 mg/kg every 8 hours for 7 days with concurrent ruxolitinib.
The expansion cohort will be split into 2, including 12 individuals receiving 10 or 40 mg/kg evert 8 hours for 7 or 14 days in each cohort.2
The primary outcomes included number of individuals with treatment-related adverse events (TEAE) and serious TEAEs and overall response rate. Secondary outcomes included incidence of refractoriness, overall corticosteroid use, initiation of additional/alternative treatments for aGVHD, change or shift in stage for lower gastrointestinal aGVHD, liver aGVHD, skin aGVHD, or upper gastrointestinal aGVHD from baseline based on MAGIC criteria, attainment of stage 0 or I lower gastrointestinal aGVHD, liver aGVHD, skin aGVHD, or upper gastrointestinal aGVHD, change or shift in overall grade of aGVHD, overall survival, non-relapse mortality, and duration of hospital stay, according to the clinical trial information.2
The company is also currently conducting 2 other phase 2 clinical trials of the drug, including for newborns with moderate or severe hypoxic-ischemic encephalopathy (NCT05778188) and for patients with acute exacerbations of chronic obstructive pulmonary disease (NCT06175065), according to the news release.1
