Abliva AB announced that the goal of enrolling 40 patients for Wave 1 of the ongoing, potentially registrational, Phase 2 FALCON study has been met. The interim analysis remains on track for summer 2024. The FALCON study is a global, randomized, placebo-controlled, and potentially registrational clinical Phase 2 study evaluating the efficacy of the company?s lead candidate KL1333 in adult mitochondrial disease patients experiencing fatigue and myopathy.

The patients are recruited in two waves, Wave 1 and Wave 2, with an interim analysis separating the two. 40 patients have now been enrolled (randomized). The interim analysis, on track for mid-2024, will include data from the Wave 1 patients?

first six months of dosing. This analysis will include a futility analysis as well as a sample size calculation for Wave 2 and will determine the final number of patients to be recruited into the full, potentially registrational, study.