July 25, 2017 3:15 PM ET

Pharmaceuticals

Company Overview of Umecrine Cognition AB

Company Overview

Umecrine Cognition AB engages in research and development within the field of gamma-aminobutyric acid (GABA) steroids and inhibitors of such steroids within the indication area of Alzheimer disease. It develops pharmaceutical agents against negative mental and neurological symptoms caused by endogenous central nervous system (CNS) active stress and sex steroids. The company was founded in 2006 and is based in Solna, Sweden. Umecrine Cognition AB operates as a subsidiary of Umecrine AB.

Karolinska Institutet Science Park

Fogdevreten 2

Solna,  171 65

Sweden

Founded in 2006

Phone:

46 8 52 48 44 82

Key Executives for Umecrine Cognition AB

Chief Executive Officer
Senior Development Adviser and Director
Age: 71
Chief Scientific Officer
Age: 69
Compensation as of Fiscal Year 2017.

Umecrine Cognition AB Key Developments

Umecrine Cognition AB Announces Inclusion of First Patient in Clinical Phase Ib/IIa of GR3027

Umecrine Cognition AB announced 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. 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. 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.

Umecrine Cognition AB Presents at 9th Annual Conference Biotech Showcase, Jan-09-2017

Umecrine Cognition AB Presents at 9th Annual Conference Biotech Showcase, Jan-09-2017 . Venue: Hilton San Francisco Union Square, 333 O'Farrell Street, San Francisco, CA 94102, United States.

Umecrine Cognition AB Announces Positive Phase 1 Data with GR3027 in Hepatic Encephalopathy

Umecrine Cognition AB announced positive top-line results from its Phase 1 first in human clinical trial with GR3027, a novel orally active GABAA receptor modulating steroid antagonist, in development for treatment of hepatic encephalopathy (HE) in patients with liver cirrhosis. The study demonstrated that GR3027 was safe and well tolerated, and also showed CNS target engagement. Umecrine Cognition’s lead candidate GR3027 is designed to reduce GABAA receptor mediated inhibition of brain function by antagonizing endogenous inhibitory neurosteroids such as allopregnanolone. Enhanced GABAA receptor mediated signaling is a key driver for the neurological symptoms associated with HE. In the current trial, GR3027 was found to be well tolerated with no serious adverse events reported and with dose proportional pharmacokinetics. Assessment of Saccadic Eye Velocity and self-rated sedation after a challenge with allopregnanolone showed evidence that orally administered GR3027 antagonizes neurosteroid modulation of GABAA receptor function. The primary objectives of the study were to evaluate the safety and tolerability of GR3027 after single dose administration in healthy volunteers and to identify the Maximum Tolerated Dose (MTD) or the Study Maximal Dose (SMD), if the MTD was not reached. The secondary objectives were to determine the single oral dose PK characteristics of GR3027 in healthy volunteers and to evaluate the capacity of GR3027 to antagonize allopregnanolone-induced activation of GABAA as determined by its pharmacodynamic effects on Saccadic Eye Velocity (SEV) and self-rated sedation. In the first part, 48 subjects were randomized to receive either GR3027 or placebo (6:2) at doses ranging from 1 mg to 200 mg. None of the pre-specified dose escalation stopping criteria were obtained and GR3027 was found to be well tolerated throughout the dose range up to the SMD of 200 mg. The pharmacokinetic profile obtained displayed dose linearity over the dose range applied. In the second part of the study, 18 subjects were randomized in a three-part cross-over design to receive either GR3027 at 3 mg (low dose) or 30 mg (high dose), or placebo. As expected, allopregnanolone administration decreased SEV in the placebo group. Prespecified statistical analysis of the difference between treatment groups with GR3027 and placebo showed a significant improvement with GR3027 in the high dose group (p=0.03; Wilcoxons Signed Rank Test). The results also provide evidence that the impaired self-rated sedation produced by allopregnanolone was also improved by GR3027. The company plans to announced further details and data of the trial at the 9th International Meeting – Steroids and Nervous System in Torino, Italy (February 11-15, 2017).

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