STOCKHOLM, 29 January 2019. Karolinska Development's (Nasdaq Stockholm: KDEV) portfolio company Umecrine Cognition today announces overall results from a phase 2a study with the candidate drug GR3027 in patients with idiopathic hypersomnia. The primary study objectives were met in regard to safety and pharmacokinetics. The study also showed preliminary evidence of clinical efficacy in a subset of patients. Umecrine Cognition will analyze the data further before a decision to potentially move forward with the development of GR3027 in idiopathic hypersomnia or other sleep disorders. In parallel, Umecrine Cognition will continue the clinical development in hepatic encephalopathy.
Idiopathic hypersomnia (IH) is an orphan disease characterized by chronic excessive daytime sleepiness (EDS) without other known causes. No approved treatments are currently available for this lifelong, often severely debilitating condition which has a profound effect on patients and their families. Umecrine Cognition's drug candidate GR3027 is an orally administered GABAA receptor modulating steroid antagonist. The drug candidate has previously been shown to improve neurological impairments - including cognitive and sleep alterations - in animal models. GR3027 is currently in clinical development for hepatic encephalopathy and sleep disorders.
The phase 2a study of GR3027 in patients with idiopathic hypersomnia enrolled 10 patients, including 5 females and 5 males, at Sleep Centers in Finland, Denmark and Sweden. The study was a randomized, double-blind, placebo-controlled crossover study where all patients were given twice daily 80 mg oral doses of GR3027 for two weeks. The Maintenance of Wakefulness Test (MWT) and the Epworth sleepiness scale (ESS) were designated as the main exploratory efficacy measures. MWT objectively measures the patients' ability to stay awake in a controlled setting while ESS is based on patients' subjective assessment of sleepiness. Additionally, a number of other exploratory measures of efficacy were followed.
The results suggest that the pharmacokinetic and safety profile of the drug candidate in female populations are in line with those previously documented in male populations. The safety profile, which has previously been studied for up to 5 days of multiple ascending doses in adult males, continues to be favorable with no dose-limiting toxicities or serious adverse events (SAEs) in either males or females.
The results of the ability to stay awake, as determined by the objective measurement MWT, showed a favorable trend (p = 0.098). The drug candidate GR3027 had little effect on the subjective measurement ESS (p = 0.92). As expected in a small exploratory study, none of the results were statistically significant. A subgroup of 5 out of 10 subjects exhibited directionally favorable changes in 3 or more efficacy measures. Altogether, Umecrine Cognition deems that the favorable pharmacokinetic and safety results, together with these early indications of clinical effect in a subset of patients, suggest that GR3027 merits further evaluation in hypersomnia and other sleep disorders.
"Idiopathic hypersomnia is a complex disease with a heterogenous patient population. The fact that indications of clinical effect have been observed even in this small study with a relatively short period of treatment is encouraging. Umecrine Cognition will now analyze the data further before a decision to potentially progress the development in either idiopathic hypersomnia or other sleep disorders. We also look forward to phase 2-data of GR3027 for treatment of hepatic encephalopathy in 2020," comments Viktor Drvota, CEO, Karolinska Development.
More detailed information on the study and its results will be made available on Umecrine Cognition's website: www.umecrinecognition.com.
Karolinska Development holds an ownership of 72% in Umecrine Cognition.
For more information, please contact:
Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com
Fredrik Järrsten, CFO, Karolinska Development AB
Phone: +46 70 496 46 28, e-mail: fredrik.jarrsten@karolinskadevelopment.com
TO THE EDITORS
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 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 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: www.karolinskadevelopment.com.
This information is information that Karolinska Development AB (publ) (Nasdaq Stockholm: KDEV) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of Viktor Drvota, at 19:05 CET on 29 January 2019.
