Umecrine Cognition is developing golexanolone, a clinical Phase 2 drug candidate intended for symptomatic treatment of the chronic autoimmune disease primary biliary cholangitis (PBC). The PBC Foundation is the world’s largest support organization for patients with primary biliary cholangitis, offering practical support and information to patients and families as well as advocacy and representation in influential national and international forums.

The PBC International Summit is an annual meeting organized by PBC Foundation to identify and convert patient-driven initiatives to real-world activities. This effort, led together by the global PBC investigator community and global patient advocacy groups, guided by regulatory bodies such as the EMA, FDA and MHRA, provides an important platform for advancing the understanding of PBC and informing future therapeutic interventions. Additionally, at the 2025 summit, the pharmaceutical sector will be represented by tone-giving companies that are involved in the development and commercialization of novel treatments for PBC.

“We are very happy to have been selected among many actors to attend the 2025 International PBC Summit. At the meeting, we look forward to presenting key insights from the development of golexanolone, both in preclinical and clinical settings, and discussing meaningful treatment solutions in the PBC area. Apart from sharing knowledge, we look forward to gaining new insights in dialogues with medical advisors, patient advocacy groups, and industry representatives,” says Magnus Doverskog, SVP and CSO at Umecrine Cognition.

At the meeting, interim data and the current status of the company’s ongoing Phase 1b/2a trial with golexanolone in PBC with fatigue and cognitive dysfunction, central fatigue, will be presented by the company’s CSO, Dr. Magnus Doverskog. In particular, Dr. Doverskog will present the development of CGI-S-PBC™ (Clinical Global Impression Severity Primary Biliary Cholangitis), a novel clinician-rated outcomes scale, or COA (Clinical Outcome Assessment). Umecrine Cognition is pioneering the area of symptomatic treatment within PBC as the first company to develop a treatment directly targeting the debilitating CNS-mediated fatigue. The CGI-S-PBC™ is used to measure patients’ perceived symptom severity more objectively, thereby creating a new set of robust clinical endpoints for the development of novel pharmaceutical treatments targeting cognitive symptoms. Such scales have been used previously in other disease areas, specifically within neurology. CGI-S-PBC™ is currently used in the company’s ongoing clinical Phase 1b/2a trial with golexanolone.

For further information, please contact:
Magnus Doverskog, SVP & CSO, Umecrine Cognition AB
Phone: +46 73 039 20 52, email: magnus.doverskog@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.