Abliva Announces Completion of 24 Weeks of Dosing in Wave 1 of the FALCON Study of KL1333 in Primary Mitochondrial Disease

-With 24 weeks of dosing complete, Abliva remains on track to report the interim analysis in early Q3 2024-

Abliva AB (Nasdaq Stockholm: ABLI) a clinical-stage company developing medicines for the treatment of rare and severe primary mitochondrial disease, today announced that the Wave 1 cohort has completed 24 weeks of dosing in the ongoing Phase 2 FALCON trial of KL1333 for the treatment of primary mitochondrial disease. These data will be reviewed by the Independent Data Monitoring Committee (DMC), with results from the interim analysis expected in early Q3 2024. In addition to evaluating the interim safety data, the DMC will make a recommendation as to whether to continue the study and advise on the final study size.
“We are pleased that the Wave 1 patients have now been dosed for at least 24 weeks, an important milestone that moves us one step closer to delivering the first medicine for systemic mitochondrial disease and addressing the high unmet needs of these patients,” said Ellen Donnelly, Chief Executive Officer of Abliva. “We are now well positioned to report the interim analysis after review by the DMC in early Q3, 2024. The analysis will provide the first view of KL1333’s safety profile when dosed twice daily for 24 weeks and determine whether the primary endpoints are predicted to reach statistical significance after 48 weeks of dosing. We believe the planned sample size re-estimation for Wave 2, following the interim analysis, will optimize the trial design and increase the probability of success.”