STOCKHOLM, SWEDEN – December 13, 2019. Karolinska Development´s portfolio company Umecrine Cognition announces today that the enrollment has been completed in its Phase 2a study designed to assess the safety, pharmacokinetics and potential benefit of golexanolone in patients with liver cirrhosis and hepatic encephalopathy.
Umecrine Cognition is developing golexanolone (GR3027), a novel GABAA receptor modulating steroid antagonist with a potential to improve brain function in a wide range of cognitive disorders. Golexanolone is presently in clinical development for hepatic encephalopathy (HE), a serious neuropsychiatric and neurocognitive complication in acute and chronic liver disease (including cirrhosis). At present there are no treatments available that directly target the brain abnormalities believed to be responsible for HE.
The study UCAB-CT-02 is a prospective, double-blind, randomized, placebo-controlled multi-center phase 1b/2a protocol in four parts enrolling healthy adults and patients with cirrhosis. The purpose of the study is to evaluate the safety and pharmacokinetics of multiple ascending doses of golexanolone, as well as its potential effect on cognitive function in patients with cirrhosis and impaired cognition.
The first three parts of the study shows that golexanolone is well tolerated, does not cause any dose-limiting side effects and has a favourable pharmacokinetic profile. The announcement today reports the completion of enrollment to the fourth and last part of the protocol, phase 2a. In this part 45 adult male and female patients with cirrhosis (Child-Pugh A or B) without manifest HE and with an abnormal cognitive status were randomized to receive golexanolone or placebo for three weeks. Results are expected in mid H1 2020.
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com
TO THE EDITORS
About Karolinska Development AB
Karolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying breakthrough medical innovations in the Nordic region that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that advance these assets into commercial products that are designed to make a difference to patients' lives while providing an attractive return on investment to shareholders.
Karolinska Development has access to world-class medical innovations at the Karolinska Institutet and other leading universities and research institutes in the Nordic region. The Company aims to build companies around scientists who are leaders in their fields, supported by experienced management teams and advisers, and co-funded by specialist international investors, to provide the greatest chance of success.
Karolinska Development has a portfolio of nine companies targeting opportunities in innovative treatment for life-threatening or serious debilitating diseases.
The Company is led by an entrepreneurial team of investment professionals with a proven track record as company builders and with access to a strong global network.
For more information, please visit www.karolinskadevelopment.com
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