Abliva AB (Nasdaq Stockholm: ABLI) a clinical-stage company developing drugs for the treatment of rare and severe primary mitochondrial disease, today announced that the company’s lead candidate KL1333 has received Fast Track designation from the U.S. Food and Drug Administration (FDA), facilitating its clinical development and path forward to market.
Abliva’s lead drug candidate KL1333 is currently being evaluated in the FALCON study, a global, potentially registrational, Phase 2 study in mitochondrial disease patients. Dosing was initiated in June this year, and an interim analysis is expected towards the middle of 2024.
The FDA has now granted KL1333 Fast Track designation. This designation gives Abliva the possibility for more frequent meetings and written communication with the FDA. In addition, it will allow Abliva to receive continuous feedback on each section of the New Drug Application (NDA) (for sale and marketing in the U.S.) for KL1333, with expedited review and accelerated approval if certain criteria are met.
“The Fast Track designation is a quality stamp for our lead candidate and will facilitate our regulatory interactions in the U.S. This designation is one more important step forward as we prepare for a favorable interim analysis on the path towards bringing a new therapy to patients in this area of extremely high unmet medical need”, said Ellen Donnelly, CEO.