Fredag 4 April | 06:27:49 Europe / Stockholm

Prenumeration

2025-03-18 14:45:00

STOCKHOLM – March 18, 2025. Umecrine Cognition today announces that its Phase 1b/2a study of golexanolone has been delayed due to technical issues with the production of capsules used in the study. This issue does not impact patient safety, and the manufacturer is working diligently to resolve these temporary supply challenges.

“We regret that the supply issue will temporarily impact the pace of patient recruitment in the ongoing clinical study of golexanolone, but we are confident that the manufacturing problem can be diligently resolved,” said Anders Karlsson, CEO of Umecrine Cognition.

Umecrine Cognition is developing golexanolone, a clinical-stage drug candidate targeting impaired cognitive function and central fatigue in Primary Biliary Cholangitis. Golexanolone is currently being evaluated in a two-part Phase 1b/2a clinical study. The ongoing second part of the clinical study (part B) aims to further document the pharmacological profile of golexanolone, as well as evaluate the treatment’s efficacy on cognitive symptoms and fatigue in PBC patients.

For further information, please contact:

Anders Karlsson, CEO, Umecrine Cognition AB
Phone: +46 70 – 918 00 10, e-mail: anders.karlsson@umecrine.se

About Umecrine Cognition

Umecrine Cognition AB is developing a completely new class of drugs for the treatment of symptoms in the central nervous system related to chronic neuroinflammation – a devastating brain distortion that can lead to severely impaired cognition and fatigue. Chronic neuroinflammation can occur as a result of a number of underlying conditions, including a range of liver diseases as well as neurodegenerative diseases, such as Parkinson’s disease. Results from an internationally acclaimed Phase 2 clinical study indicate that the company's most advanced drug candidate, the GABAA receptor-modulating steroid antagonist golexanolone, normalizes brain signaling and improves cognition and alertness in patients with hepatic encephalopathy. A Phase 2 study is currently ongoing in patients with primary biliary cirrhosis. Further, based on intriguing preclinical data, the company is considering pursuing the development of golexanolone in patients with Parkinson’s disease. For more information, visit www.umecrinecognition.com.