Abliva AB (Nasdaq Stockholm: ABLI), a clinical-stage biopharmaceutical company developing medicines for the treatment of rare and severe primary mitochondrial diseases, today announced the completion of its clinical Phase 1a/b study with KL1333, Abliva’s drug candidate for chronic oral treatment of primary mitochondrial diseases. No serious adverse events (SAEs) have been reported, and study data will be evaluated during the spring and early summer.
The primary aim of this double-blind, randomized, placebo-controlled Phase 1a/b study is to assess the safety and pharmacokinetics of KL1333, both in healthy volunteers and in patients with primary mitochondrial disease. All study participants have now completed the study. The next step is to process and evaluate data, where biomarkers and clinical outcome measures also will be assessed.
A total of 64 healthy volunteers and eight patients have been included in the study, conducted in the UK.
“On behalf of the Abliva team, I’d like to express our sincere gratitude to the persons who participated in the study and to the clinical teams at Covance in Leeds, in Newcastle led by Prof. Gorman, and in London led by Dr. Pitceathly. They have made this possible despite a serious pandemic, and their efforts will help advance the KL1333 development program substantially and increase the knowledge in this field of medical science”, said Abliva’s Chief Medical Officer Magnus Hansson.
Abliva plans to start a registrational clinical Phase 2/3 efficacy study during the second half of 2021. Preparatory activities, including a drug-drug interaction study, a patient registry study and a study to validate key patient-reported outcome measures for the efficacy study are either ongoing or being finalized. Results from these studies will ensure that the Phase 2/3 study is positioned for success.