Abliva drug candidate NV354 to progress to clinical development following positive regulatory review

Abliva AB (Nasdaq Stockholm: ABLI), a clinical-stage biopharmaceutical company developing medicines for the treatment of rare and severe primary mitochondrial diseases (PMD), today announced that a second program in the portfolio, NV354, will move to the clinic after having received favorable feedback from the regulatory authority in the UK, the MHRA, on the preclinical package. The team will now continue assembling the documentation necessary to support a Phase 1 clinical start in 2022.

NV354, a precision-based therapy invented within Abliva’s own research laboratories, targets a dysfunctional metabolic pathway which occurs in a number of mitochondrial diseases including Leigh sydrome, a devasating childhood disease. This novel therapy has been designed to provide an alternative source of energy, succinate, to the patient’s cells via a unique prodrug strategy that aims to arrest disease progression, reduce mortality and improve the overall quality of life for children with Leigh syndrome.

As a gating mechanism to progress NV354 to clinical development, the Abliva team met with the UK regulatory agency to discuss the preclinical data package. With the success of that meeting the team will now continue assembling the documentation required for a Clinical Trial Application (CTA) to support Phase 1 clinical start in 2022.

“The progression of NV354 to the clinic is exciting as it shows that our team has the ability to make important research discoveries and convert those discoveries into clinical candidates,” said Ellen Donnelly, CEO of Abliva. “The advancement of NV354 is important as this candidate will join lead candidate, KL1333, in the clinic next year, giving us a pipeline of products and additional opportunity for newsflow and catalysts to bring additional value to shareholders,” Donnelly continued.