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RLS-0071 granted orphan drug designation and fast track designation by the U.S. FDA
On August 19, 2024, the U.S. Food and Drug Administration (FDA) granted orphan drug designation and fast track designation to RLS-0071, an investigational dual-targeting anti-inflammatory peptide, for the treatment of patients with steroid-refractory acute graft-versus-host disease (SR-aGvHD).1 RLS-0071 has a novel dual mechanism of action, modulating the complement and innate inflammatory pathways.1 A phase II trial (NCT06343792) to assess the safety and efficacy of RLS-0071 in hospitalized patients with SR-aGvHD is currently ongoing.1
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