Abliva AB (Nasdaq Stockholm: ABLI), a clinical-stage biopharmaceutical company developing medicines for the treatment of rare and severe primary mitochondrial diseases, today announced that the US Food and Drug Administration has approved Abliva’s Investigational New Drug (IND) application for KL1333, enabling the start of a registrational Phase 2/3 study with first patients due to be recruited in 2022.
“The approval of the IND is an important milestone for Abliva as it means that the FDA has reviewed the full package of data supporting KL1333 and the proposed design of our Phase 2/3 study and has given us permission to proceed to dosing of PMD patients with KL1333”, said Abliva’s CEO Ellen Donnelly. “We can now commence our global, registrational Phase 2/3 study with KL1333, continued Donnelly.”
“With this approval, we now intend to move forward with a financing round. The Board has growing confidence that the quality of the asset and the IND approval are attractive to specialist life science investors and companies”, said
David Laskow-Pooley, Chair of Abliva AB.