The patent application protects a new oral formulation of sodium valproate for the pretreatment of cancer, as well as any other use of the formulation. The application is valid for at least 20 years from the date of priority, during which time it confers exclusive rights on the market.

The tailored release profile of VAL001, which combines immediate-release and­ delayed-release properties of sodium valproate, was evaluated as previously reported in a pharmacokinetic (PK) study in healthy subjects with expected results. The plasma concentration of valproate after twice daily administration of VAL001 was similar to that achieved with the reference formulation, dosed three times daily. Advantageously, VAL001 resulted in lower peak concentrations of valproate, as well as more constant plasma concentration over time, compared to the reference formulation.

In addition to the favorable PK profile, analysis of a biomarker for histone acetylation, which predicates the effect of valproate, also showed positive results. The expression of the biomarker was higher at all measured time points and at most 40 percentage points higher at 48 hours after dosing with VAL001 compared to the reference formulation. 48 hours is the time point when the immunochemotherapy with R-CHOP is initiated, why this is an important result.

In addition to enabling simplified dosing twice daily instead of three times daily, the results suggest that the effect of the new formulation may be better, even though the total exposure, and thus the likely risk of side effects, does not increase. A modified PK profile is also an important part of an improved differentiation from generic valproate and better regulatory protection.

This disclosure contains information that Respiratorius is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 30-06-2023 12:15 CET.