Affibody’s licensee Rallybio Corporation has announced positive topline results from a Phase I single ascending dose study in healthy participants of RLYB116, a novel, potentially long-acting, subcutaneously administered inhibitor of complement factor 5, or C5, in development for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and generalised Myasthenia Gravis (gMG).
In the ongoing Phase I study, all study participants that were administered a single 1mL subcutaneous injection of 100 mg of RLYB116 (n=6), which demonstrated a reduction in free C5 greater than 99% within 24 hours of dosing. The terminal elimination half-life of RLYB116 was greater than 300 hours.
Subcutaneously administered RLYB116 was observed to be generally well-tolerated at the 100mg dose, with mild or moderate adverse events and no drug-related serious adverse events reported.
The single-blind, placebo-controlled (3:1) dose escalation study was initiated in February 2022 and is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of single subcutaneous dose RLYB116 in healthy participants and includes five dose cohorts (2, 10, 30, 100, 300 mg RLYB116) with each enrolling eight participants.
Post-treatment study follow-up is expected to continue for 10 weeks.