First notice of allowance of patent and top-line results from PK study of VAL001 available

Respiratorius announces that the patent application for the formulation of VAL001 has been allowed by a formal notice of allowance from Japan Patent Office.

Respiratorius also announces that preliminary top-line results from the PK study with VAL001 are available.

The patent application, claiming a novel and dedicated oral formulation of sodium valproate for pretreating cancer, has been allowed by the Japan Patent Office. The priority date of the patent application is 21 April 2016 and in force for at least 20 years from the priority date granting market exclusivity.

The tailored release profile of VAL001, combining immediate release and extended-release characteristics of sodium valproate, was evaluated in the pharmacokinetic (PK) study in healthy subjects. Based on preliminary data the concentration of valproate with twice daily dosing of VAL001 is in the expected range, and similar to what was achieved with the reference, dosed three times daily, which was the dosing scheme that was applied in the VALFRID (phase I/IIa) study. Further in-depth analysis of the data from the PK study is ongoing.

"We are very pleased that Japan, as the first country allows the patent application. It is also very timely with the top-line results, which will be a cornerstone in the partnering process” says CEO Johan Drott in a comment.

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 16-09-2022 08:00 CET.