Abliva initiates a drug-drug interaction study and paves the way for a KL1333 pivotal study in 2021

Abliva AB (Nasdaq Stockholm: ABLI), a clinical-stage biopharmaceutical company developing medicines for the treatment of rare and severe primary mitochondrial diseases, today announces dosing in the first healthy volunteers in the company’s drug-drug interaction (DDI) study with KL1333, the study recommended by the US Food and Drug Administration (FDA), which will assist the program to move directly into a pivotal Phase II/III study in patients with primary mitochondrial disease in 2021.

The DDI study is aimed to assess the potential impact of KL1333 on drugs used by treating physicians as part of the current standard of care. A total of 14 healthy volunteers will receive a daily dose of KL1333 together with a cocktail of other drugs for 12 days. The DDI study is part of a preparatory program ahead of the initiation of the Phase II/III study. The preparatory program also includes a qualitative validation study of specific patient-reported outcome measures, a clinical dosing study, a patient registry study, and initiation of long-term in vivo toxicology studies.

These activities will run in parallel with the planning of the Phase II/III study and the ongoing Phase Ia/b study. Four out of a total of eight patients have already been dosed in the patient portion of the Phase Ia/b study. Separately, a healthy volunteer portion will be added to the Phase Ia/b study to provide additional insight on the pharmacokinetics of KL1333. In addition, information provided by the MitoCohort UK (Newcastle University) primary mitochondrial disease registry study will be used to enhance the recruitment protocol of the pivotal Phase II/III study.

“The ongoing preparatory activities are important steps towards the start of the planned Phase II/III study in the second half of next year. We are truly excited about accomplishing the required studies and then initiating the pivotal patient study, as these studies may bring a much-needed novel treatment to patients with primary mitochondrial disease”, said Erik Kinnman, CEO at Abliva.