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STOCKHOLM, SWEDEN – May 19, 2022. Karolinska Development AB (Nasdaq Stockholm: KDEV) today announces that its portfolio company Umecrine Cognition has submitted a clinical trial application (CTA) to the Hungarian regulatory body OGÝEI for approval to initiate a Phase 2 clinical trial of its drug candidate golexanolone in patients suffering from primary biliary cholangitis. The study is planned to be conducted at several European clinical trial centers.
Umecrine Cognition's drug candidate golexanolone represents a novel drug class that modulates the activity of the GABAA receptor in order to counteract cognitive impairment associated with liver disease and associated inflammation in the brain. Golexanolone is being developed in the indications of primary biliary cholangitis (PBC), which leads to inflammation and degeneration of the bile ducts, and hepatic encephalopathy (HE).
The randomized, double-blind, placebo-controlled Phase 2 clinical trial will compare golexanolone to placebo in up to 150 patients with non-cirrhotic liver or Child-Pugh class A cirrhotic PBC who, despite treatment with conventional therapy, show clinically significant fatigue and cognitive symptoms. The study will be conducted in two phases – part A and part B. In part A, the study will evaluate the pharmacokinetics, safety and tolerability of the drug candidate. In part B, the safety and tolerability will be further evaluated, as well as the preliminary treatment effect of golexanolone in the same patient population.
The study is expected to start in the summer of 2022. The results from part A are expected to be presented before the end of the year and the results of part B in the second half of 2023. The full results of the study are expected to be presented in 2024.
"The submission of the Clinical Trial Application to the Hungarian regulatory body OGÝEI means that preparations for the planned Phase 2 study of Umecrine Cognition's drug candidate golexanolone are now entering their final stages. Golexanolone has the potential to revolutionize the treatment of cognitive disorders in patients with liver disease, and a favourable outcome of the study would be a major step towards this goal," said Viktor Drvota, CEO, Karolinska Development.
Karolinska Development's ownership in Umecrine Cognition amounts to 73 percent.
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com
Johan Dighed, General Counsel and Deputy CEO, Karolinska Development AB
Phone: +46 70 207 48 26, e-mail: johan.dighed@karolinskadevelopment.com