Abliva AB (publ) announced that the company has now included the target number of patients required for screening in Wave 1 of the FALCON study. The study therefore remains on track to have all Wave 1 patients commence dosing by the end of the year with the interim analysis towards the middle of 2024. Abliva is currently running the FALCON study, a global, randomized, placebo-controlled, and potentially registrational clinical Phase 2 study evaluating the efficacy of KL1333 in adult mitochondrial disease patients experiencing fatigue and myopathy. The target number of patients required for Screen 1 of the study has now been met. Screened patients have been, and will continue to be, evaluated for initiation of dosing in the study, with the goal that all eligible patients will have initiated dosing by the end of 2023. In the FALCON study, patients who meet the initial criteria are evaluated during a screening period, during which time their genetic background and a baseline of consistent fatigue and myopathy is confirmed. Patients that satisfy the necessary criteria commence dosing at the end of their screening period.
The FALCON trial has an adaptive study design with an interim analysis that will determine the final number of patients to be recruited in the full study (Wave 1+ Wave 2) to support a potentially registrational dataset.