Karolinska Development’s portfolio company Umecrine Cognition presents new data supporting the development of golexanolone as a treatment of primary biliary cholangitis
04 November 2021 - 01:44AM
Karolinska Development’s portfolio company Umecrine Cognition
presents new data supporting the development of golexanolone as a
treatment of primary biliary cholangitis
STOCKHOLM, SWEDEN – November 3, 2021. Karolinska Development AB
(Nasdaq Stockholm: KDEV) announces today that the portfolio company
Umecrine Cognition will present new scientific results showing that
the innate neurosteroid allopregnanolone plays an important role in
the development of cognitive symptoms observed in patients with
primary biliary cholangitis (PBC). Since Umecrine Cognition’s drug
candidate golexanolone could potentially impact allopregnanolone
the company has, based on the novel clinical results and other
supportive data, initiated preparations for a Phase 2 clinical
study in PBC. Umecrine Cognition will present the data at The Liver
Meeting Digital ExperienceTM 2021, the premier Annual Meeting of
the American Association for the Study of Liver Diseases (AASLD),
which takes place November 12-15.
Umecrine Cognition is developing golexanolone, a novel drug
candidate that counteracts the effect of allopregnanolone on GABAA
receptors, thereby restoring normal nerve signalling in the brain.
Golexanone is currently in clinical development for hepatic
encephalopathy.
In a recently conducted study, in collaboration with Newcastle
University and the UK-PBC organization, Umecrine Cognition
evaluated the association between allopregnanolone and health
related quality of life in patients with primary biliary
cholangitis (PBC), using a validated and trusted disease-specific
measure (PBC-40). In the study, serum allopregnanolone levels were
analyzed in 160 subjects, including 120 PBC patients and 40 age-
and gender-matched healthy controls. Further, serum
allopregnanolone was compared across the PBC-40 domains for those
exhibiting no or mild symptoms and those exhibiting severe
symptoms.
The study results revealed two key insights. Firstly, elevated
serum levels of allopregnanolone were significantly associated with
severe cognitive and emotional symptoms (p=0.02 and p=0.004,
respectively) as well as with itch (p=0.03). These results align
well with what is expected from drug interactions with GABAA
receptors. Secondly, the results indicate that younger age was
predictive of significantly higher allopregnanolone levels within
the PBC cohort (p<0.001), but not in healthy controls (p=0.119).
In association, younger age was coupled to more severe cognitive
symptoms (severe vs. none; p=0.001). Based on these new findings
and other supportive data, Umecrine Cognition has decided to
prepare a Phase 2 clinical trial in PBC patients.
“Umecrine Cognition’s recent research finding, identifying
golexanolone’s drug target allopregnanolone as a novel serum
biomarker for fatigue and cognitive disturbances in primary biliary
cholangitis, paves the way for expanding the clinical development
of golexanolone to this medically underserved disease," comments
Viktor Drvota, CEO of Karolinska Development.
Primary biliary cholangitis is a chronic autoimmune disease that
attacks the bile ducts and can result in liver cirrhosis. Most
people affected are women aged 40-60 years. There is currently no
cure for the disease. As the liver is attacked, the level of
inflammation in the brain increases, leading to personality
changes, confusion and decreased consciousness. Around 190,000
patients are currently living with the disease in the seven largest
geographical pharmaceutical markets.
The study results will be presented at The Liver Meeting Digital
Experience™ under the topic “Cholestatic and autoimmune liver
disease” A link to the abstract can be found here:
https://aasldpubs.onlinelibrary.wiley.com/doi/epdf/10.1002/hep.32188
(no. 1282).
Karolinska Development's direct ownership interest in Umecrine
Cognition amounts to 70%.
For further information, please
contact:
Viktor Drvota, CEO, Karolinska Development AB Phone: +46 73 982
52 02, e-mail: viktor.drvota@karolinskadevelopment.com
Johan Dighed, General Counsel and Deputy CEO, Karolinska
Development ABPhone: +46 70 207 48 26, e-mail:
johan.dighed@karolinskadevelopment.com
TO THE EDITORS
About Karolinska Development ABKarolinska
Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences
investment company. The company focuses on identifying breakthrough
medical innovations in the Nordic region that are developed by
entrepreneurs and leadership teams. The Company invests in the
creation and growth of companies that advance these assets into
commercial products that are designed to make a difference to
patients' lives while providing an attractive return on investment
to shareholders.
Karolinska Development has access to world-class medical
innovations at the Karolinska Institutet and other leading
universities and research institutes in the Nordic region. The
Company aims to build companies around scientists who are leaders
in their fields, supported by experienced management teams and
advisers, and co-funded by specialist international investors, to
provide the greatest chance of success.
Karolinska Development has a portfolio of ten companies
targeting opportunities in innovative treatment for
life-threatening or serious debilitating diseases.
The Company is led by an entrepreneurial team of investment
professionals with a proven track record as company builders and
with access to a strong global network.
For more information, please visit
www.karolinskadevelopment.com.
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