Umecrine Cognition patient survey on Impact of Fatigue in PBC selected as a Poster of Distinction for The Liver Meeting 2026

Data show patients suffer from PBC-related fatigue and cognitive dysfunction despite receiving first- and second line treatment
The survey was completed by 250 patients with PBC in an international cohort, combining reported symptom burden with validated clinical questionnaires. All respondents reported current treatment with standard of care for PBC. Central fatigue, the cognitive symptoms patients with PBC-related fatigue describe as "brain fog", together with memory and concentration problems, was the most frequently reported symptom, affecting 92 percent of respondents. When respondents were grouped for fatigue severity using previously established PBC-40 fatigue-domain thresholds as having mild, moderate, or severe fatigue, 44 percent were categorized as severe.

Severity mattered: patients with severe fatigue reported progressively worse health-related quality of life compared to those with moderate or mild symptoms (p<0.05), and 79 percent reported limitations in their usual activities, compared with 23 and 12 percent (p<0.05) in those with moderate or mild fatigue. Among patients with severe fatigue, health-related quality of life scores were largely independent of concomitant pruritus, suggesting that itch was not a contributing factor in patients with severe fatigue. Association was observed between degree of fatigue and employment status in that 44 percent of patients with severe fatigue reported being unable to work, worked part time or had retired because of their illness, compared with 16 and 6 percent of those with moderate and mild symptoms. Asked which single PBC symptom most needs a treatment, 60 percent named central fatigue.

Golexanolone has the potential to address key symptoms
The findings quantify the unmet need golexanolone is being developed to address. Approved PBC therapies target the underlying liver-associated disease process, while fatigue and cognitive dysfunction, the symptoms patients rank as most burdensome, remain untreated. Golexanolone is a novel drug candidate designed to normalize brain signaling and is being evaluated in a Phase 1b/2a study in PBC patients. The first part of the study showed golexanolone was safe and well tolerated at the exposures targeted for treatment effect. The second part is ongoing, with topline results expected in November 2026.

“Our data, to be presented at The Liver Meeting 2026, bring together industry, academia, the patient community and market access expertise, and speak to a central discussion in the management of PBC. Patients are unambiguous, fatigue and cognitive dysfunction are the symptoms that weigh most heavily on their daily lives and the ones they most want treated, regardless of itch status and in parallel with standard of care. Our own clinical data add the other half of the picture; Part A of our Phase 1b/2a study showed that golexanolone was safe in this population and that studies of this kind can be conducted in PBC patients, which now makes it possible to test whether these symptoms can be treated. We look forward to presenting new clinical data from our ongoing study in the coming quarter,” comments Magnus Doverskog, Chief Scientific Officer of Umecrine Cognition.

The poster “Impact of Fatigue on Perceived Quality of Life in Patients with Primary Biliary Cholangitis (PBC)” will be presented during the session “Human Cholestatic and Autoimmune Liver Diseases” on November 5, at 12:00 pm – 1:00 pm (MDT).

For further information, please contact:

Viktor Drvota, CEO, Umecrine Cognition AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@umecrine.se

About the Phase 1b/2a study UCAB-CT-05
UCAB-CT-05 is a randomized, double-blind, placebo-controlled, two-part Phase 1b/2a study designed to evaluate the safety, pharmacokinetics and preliminary efficacy of golexanolone in patients with primary biliary cholangitis (PBC) who experience clinically significant fatigue and cognitive symptoms. Part A (5 days, 40 mg twice daily) assessed safety and pharmacokinetics, while Part B (28 days, 40 mg or 80 mg twice daily) is evaluating efficacy using validated patient-reported and clinical measures, including the PBC-40 domains, EQ-5D-3L, the Epworth Sleepiness Scale, a cognitive test battery (PHES, RAVLT, D-KEFS) and the Clinical Global Impression of Change specific for PBC (CGI-C-PBC™). A pre-specified interim analysis concluded that recruitment could continue according to the original plan. The study is conducted at more than 30 sites across Europe and Turkey; the last patient was enrolled in August 2026, and results are expected during the fourth quarter of 2026. Further study information can be found here: https://clinicaltrials.gov/study/NCT07304843

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 cholangitis. 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.