Clinical-stage biotech firm ReAlta Life Sciences has received both the US Food and Drug Administration (FDA) orphan drug designation and fast track designation for RLS-0071.
ReAlta Life Sciences’ lead investigational therapeutic candidate, RLS-0071, is being developed for hospitalised patients with steroid-refractory acute graft-versus-host disease (aGvHD).
It is based on the firm’s EPICC peptide platform, which is designed to target complement and innate inflammatory pathways. This approach offers new hope for patients suffering from this severe condition.
The biotech company is currently conducting a Phase 2 open-label clinical trial of RLS-0071 for hospitalised patients with steroid-refractory aGvHD after receiving FDA approval in September 2023.
ReAlta Life Sciences chief medical officer Kenji Cunnion said: “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.
“RLS-0071 may address limitations of current treatment options for patients with aGvHD. We remain committed to advancing our clinical development programme with the hope of bringing this promising therapy to patients as quickly as possible.”
The FDA’s orphan drug designation is awarded to investigational therapies for rare diseases or conditions affecting fewer than 200,000 people in the US.
This designation provides ReAlta Life Sciences with several benefits, including seven years of market exclusivity after regulatory approval, exemption from FDA application fees, and tax credits for eligible clinical trials.
Additionally, the fast track process will facilitate more frequent communication with the FDA and may lead to priority review, potentially accelerating the availability of RLS-0071 to patients.
The biotech company is also advancing Phase 2 clinical trials of RLS-0071 for newborns with hypoxic-ischemic encephalopathy (HIE) and hospitalised patients with acute exacerbations of chronic obstructive pulmonary disease (COPD).
In February, the firm announced the dosing of the first patient in the Phase 2 trial of RLS-0071 for acute exacerbations of COPD.
Previously, the asset secured the FDA’s investigational new drug (IND) clearance for COPD patients.
