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Karolinska Development company Umecrine Cognition announces first patient included in clinical Phase Ib/IIa study with GR3027 for Hepatic Encephalopathy

STOCKHOLM - March 17, 2017. Karolinska Development's portfolio company Umecrine Cognition AB today announces the inclusion of the first patient in a clinical Phase Ib/IIa study of GR3027, which is in development as a potential new treatment for Hepatic Encephalopathy.  

Details from the Umecrine Cognition press release follow:

The objectives of the study (protocol UCAB-CT-02) are to evaluate the safety and pharmacokinetics of steady-state dosing in healthy adults and patients with cirrhosis, assess the potential efficacy of the GR3027 on cognitive function in patients with cirrhosis and covert HE, and determine the Phase IIb dose.

Liver disease accounts for a growing and substantial disease burden worldwide. Hepatic encephalopathy (HE) is a syndrome of impaired brain function that frequently occurs in patients with liver cirrhosis. Symptoms of HE range from subtly impaired cognition (covert HE) to confusion, decreased levels of consciousness to coma (overt HE). There are today no treatments available that directly target the brain abnormalities responsible for HE.

GR3027 is a GABAA receptor modulating steroid antagonist (GAMSA) designed to antagonize GABAA receptor activation by endogenous neuroactive steroids. GR3027 has been shown to improve or normalize cognitive function and learning in two models of HE. In a single ascending dose study in healthy volunteers, GR3027 exhibited satisfactory safety and linear PK, and a human challenge study further indicated that GR3027 enters the CNS and can reverse the inhibitory effects of the endogenous neurosteroid allopregnanolone on brain function. Collectively, the findings strongly implicate neurosteroid activation of GABAA receptors in the pathogenesis of HE and indicate that GR3027 shows promise as novel treatment for this disorder.

Magnus Doverskog, CEO of Umecrine Cognition, said: "Based on the encouraging results from the completed Phase Ia study in healthy volunteers, we are excited to start exploring GR3027 in patients with cirrhosis, a population in need of new treatments to improve the impaired neurological functions that severely affect their lives."

Viktor Drvota, Deputy CEO and Chief Investment Officer at Karolinska Development, said: "This is positive news for Umecrine Cognition, which has already seen encouraging early clinical results. Having also recently completed a successful financing round of SEK 45 million (US$4.9 million), the inclusion of the first patient in this Phase Ib/ IIa study is a step forward in the development of GR3027."

For further information, please contact:

Jim Van heusden, CEO, Karolinska Development AB
Phone: +46 72 858 32 09, e-mail: jim.van.heusden@karolinskadevelopment.com 

Viktor Drvota, Deputy CEO and Chief Investment Officer, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com

David Dible/Mark Swallow/Pip Batty, Citigate Dewe Rogerson
Phone: +44 20 7638 9571; e-mail: KDev@citigatedr.co.uk

TO THE EDITORS

About Umecrine Cognition AB
Umecrine Cognition, a Karolinska Development (Nasdaq Stockholm: KDEV) portfolio company, is developing a potential therapy that represents a new target class relevant for several major CNS-related disorders. The primary focus is to develop a treatment for life-threatening overt Hepatic Encephalopathy and long-term treatment in minimal Hepatic Encephalopathy in patients with liver disease, a growing area with high unmet medical need. The current lack of therapeutics that directly addresses the neurocognitive signs and symptoms of Hepatic Encephalopathy makes a novel treatment likely to become a major contribution for the treatment of this disorder. For more information, please visit www.umecrinecognition.com

About Karolinska Development AB
Karolinska 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 established a portfolio of nine 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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