STOCKHOLM – May 27, 2026. Umecrine Cognition today announced new patient survey data confirming that central fatigue, characterized by a loss of self-motivation and cognitive involvement, is the single most burdensome symptom in primary biliary cholangitis (PBC). When asked to choose only one symptom to treat, 60% of patients selected central fatigue – more than all other symptoms combined. The data will be presented at the EASL Congress 2026 in Barcelona.
The patient symptom survey, conducted in collaboration with the PBC Foundation UK, captured the lived symptom experience of 250 adults with PBC through the PBC Foundation app. Central fatigue was the most prevalent symptom reported for the last 4 weeks (92%), followed by bone/joint pain (75%), dry eyes/dry mouth (69%), peripheral fatigue (68%) and itching (49%). 86% of respondents scored moderate-to-severe fatigue on the validated PBC-40 symptom assessment tool, and more than half (56%) reported that central fatigue was the most burdensome / severe symptom on a day-to-day basis and likewise, that their worst days, symptomatically, are driven by central fatigue. The survey highlights that central fatigue is the symptom PBC patients most urgently want addressed – yet no approved therapy currently exists. This is despite broader therapeutic progress in the field, including the first approved therapy for cholestatic itch and emerging second-line options. Umecrine Cognition is developing golexanolone, a first-in-class GABAA receptor-modulating steroid antagonist, in a Phase 1b/2a study specifically for PBC patients with clinically significant fatigue and cognitive symptoms.
“Patients are telling us very clearly what matters most to them. Central fatigue, PBC-related fatigue with cognitive symptoms, is the symptom they rank above all others when asked to choose just one to treat. The recent approval of the first therapy for cholestatic pruritus in PBC is an important step forward for patients who suffer from severe itch, but this survey reinforces that central fatigue, and cognitive symptoms remain the largest unmet quality-of-life need in PBC, even prioritized amongst patients with itch. Golexanolone is being developed precisely to address this phenotype, as a complementary pillar within the evolving PBC symptom franchise,” comments Dr. Viktor Drvota, CEO of Umecrine Cognition.
The abstract (REG26-3270/SAT-370) “Symptom experience in patients with primary biliary cholangitis” will be presented by Mr. Robert Mitchell-Thain, CEO of PBC Foundation, UK, on May 30 at EASL 2026 in Barcelona at the session “Immune-mediated and cholestatic disease: Clinical aspects”.
For further information, please contact:
Viktor Drvota, CEO, Umecrine Cognition AB
Phone: +46 73 982 52 02, e-mail: [email protected]
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. Key efficacy assessments include changes from baseline in the PBC-40 domains (cognition, fatigue, itch, social, emotional, and general symptoms), EQ-5D-3L, 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 supports adaptive sample-size re-estimation based on conditional power. The study, conducted across more than 30 European sites, continues to recruit participants following positive interim data from the first part of the study, presented at The Liver Meeting® 2024 (AASLD).
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.