Umecrine Cognition Secures SEK 67 Million to Complete Phase 1b/2a Trial of Golexanolone for PBC-Related Fatigue
核心洞察
Umecrine Cognition (搜索) has resolved a directed share issue of SEK 67 million to finalize its Phase 1b/2a clinical study of golexanolone in primary biliary cholangitis (搜索) (PBC).
New patient survey data presented at EASL 2026 reveals that 92% of PBC patients experienced severe fatigue, with 60% naming it the symptom they most want treated.
Golexanolone is a first-in-class GABAA receptor (搜索)-modulating steroid antagonist targeting central nervous system-driven fatigue and cognitive impairment in chronic liver disease.
Umecrine Cognition (搜索) has resolved a directed share issue amounting to SEK 67 million before transaction costs, securing the capital needed to complete its ongoing Phase 1b/2a clinical study of golexanolone in patients with primary biliary cholangitis (搜索) (PBC). The financing, announced June 8, 2026, drew participation from both existing long-term investors and new strategic investors, and was partially paid for by the set-off of outstanding claims.
The proceeds will support patient inclusion, preparation and presentation of study results, and the company's operational expenses as it approaches key readouts from the trial. Results are expected in the second half of 2026.
"We welcome the participation of both new and existing investors in Umecrine Cognition (搜索)'s capital raise. The company is approaching key readouts from the ongoing phase 1b/2a study of golexanolone, a novel drug candidate targeting disease-driven central fatigue and cognitive impairment in primary biliary cholangitis (搜索)," said Dr. Viktor Drvota, CEO of Umecrine Cognition. "The capital injection will support operations through the finalization of the study and into the next phase of the project's development."
The Unmet Need: Fatigue as the Dominant Symptom Burden in PBC
The urgency of developing targeted therapies for PBC-related fatigue was underscored by new patient survey data presented by Umecrine Cognition (搜索) at the EASL 2026 scientific conference in Barcelona on May 30. Conducted in collaboration with the PBC Foundation UK, the survey captured perceived symptom burden among 250 adults with PBC via the PBC Foundation app.
The findings were striking: severe fatigue was identified as the most common symptom over the preceding four weeks, reported by 92% of participants. This was followed by bone and joint pain (75%), dry eyes and dry mouth (69%), muscular fatigue (68%), and pruritus (49%). Notably, 86% of participants reported moderate to severe fatigue on the validated PBC-40 assessment tool, and more than half (56%) singled out central fatigue as their most burdensome symptom in daily life — and the most dominant symptom during periods when their overall health is at its worst.
When asked which single symptom they would most like to see treated, 60% of patients named severe fatigue — a symptom for which no targeted pharmacological treatment currently exists.
"These findings build on data shared recently by Umecrine Cognition (搜索), showing that more than half of PBC patients live with severe fatigue and cognitive symptoms. The picture is now clearer: patients themselves are telling us that fatigue and cognitive impairment are what they most want treated, and there are no approved therapies that address them," said Dr. Drvota.
Golexanolone: A Novel Mechanism of Action
Golexanolone is a GABAA receptor (搜索)-modulating steroid antagonist that acts directly on the central nervous system to normalize brain signaling impaired by chronic neuroinflammation. Umecrine Cognition (搜索) is developing the compound as part of a new class of drugs targeting CNS symptoms arising from chronic liver disease and, potentially, neurodegenerative conditions such as Parkinson's disease.
The drug candidate has already demonstrated promise in an earlier Phase 2 clinical study in patients with hepatic encephalopathy, where it improved cognition and alertness. The current development program in PBC represents a targeted approach to address what the new patient survey data confirm is the most pressing unmet need in the disease.
Phase 1b/2a Trial Design
The ongoing study, designated UCAB-CT-05, is a randomized, double-blind, placebo-controlled, two-part Phase 1b/2a trial designed to evaluate the safety, pharmacokinetics, and preliminary efficacy of golexanolone in PBC patients who experience clinically significant fatigue and cognitive symptoms. The study is being conducted across more than 30 clinical sites in Europe and aims to enroll up to 84 evaluable patients.
Part A of the study assessed safety and pharmacokinetics over 5 days with a 40 mg twice-daily dosing regimen. Part B is evaluating efficacy over 28 days, with patients receiving either 40 mg or 80 mg twice daily. Key efficacy assessments include changes from baseline in the PBC-40 domains — covering cognition, fatigue, itch, social, emotional, and general symptoms — as well as the 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. Interim results from the initial part of the study, presented at The Liver Meeting 2024 (AASLD), showed that golexanolone was well-tolerated and safe, with only mild adverse events reported. The study continues to recruit participants following these positive interim data.
Strategic Context
KDventures (搜索) AB, the Nordic life sciences investment company listed on Nasdaq Stockholm, holds a 60% direct ownership interest in Umecrine Cognition (搜索). Dr. Viktor Drvota serves as CEO of both entities.
"Golexanolone is currently being evaluated in a Phase 1/2 study in precisely this patient group, and it has the potential to become a meaningful part of the next generation of precision treatments for PBC," Dr. Drvota stated.