Karolinska Development
 

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Umecrine Mood AB

Concept Development
Lead Discovery
Lead Optimization
Preclinical Development
Phase I
Phase II
Phase III
Launch

Project: UC1010

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The Challenge

Severe pre-menstrual syndrome (PMS) and pre-menstrual dysphoric disorder (PMDD) affect over 15 % of all fertile women1. These women suffer from recurrent depression, irritability, mood swings and anxiety, which adversely affect their ability to work and live a normal life. Symptoms occur the week before menstruation due to the effects of endogenous CNS-active steroids from the corpus luteum that affects the GABA system in the brain's emotional center.

Umecrine Mood's Solution

Umecrine Mood is developing pharmaceuticals that inhibit the action of the provoking CNS-active steroid in the brain's emotional center. The first drug candidate is a non-hormonal GABAA modulating steroid antagonist (GAMSA). It is designed to mitigate the action of the CNS-active steroids responsible for the negative pre-menstrual mood changes in women with PMDD and severe PMS.

Competitive Advantages

Umecrine Mood's treatment is being developed specifically for PMDD. Current treatment offered to sufferers of PMDD are mainly anti-depressants. Their efficacy is moderate and usually has side effects, causing many patients to discontinue treatment.

Umecrine Mood's discovery represents a novel treatment principle and the drug candidate is the first in its class.

The Market

More than seven million women suffer from PMDD in Europe and the US alone2. From a health economics perspective, an effective treatment for these conditions can be expected to be well received.  As such, there is significant market potential for a new treatment within this Women's Health/CNS segment.

Status

  • A drug candidate and two back-up compounds have been identified
  • The mechanism of action has been established
  • Proof-of-principle has been demonstrated in vitro and in animal models for anxiety and PMDD. It has also been shown clinically using a biomarker for PMDD in healthy women
  • The drug candidate has an excellent safety profile and is currently at the Phase I clinical stage

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Planned Milestones

  • Optimize the medicinal product and complete the Phase I clinical trial
  • Carry out a Phase II clinical trial in PMDD patients aimed at demonstrating proof-of-concept

Patent Status

Patents covering the drug candidate have been granted for use in PMS and PMDD in the major markets. Patents have also been granted, or are pending approval, for the company's other compounds.

Commercialization

Umecrine Mood will continue its development program up to proof- of-concept to demonstrate the effect of treatment of PMDD in a clinical Phase II study. At the same time, the company will identify potential partners for continued development. The company will seek a strategic partnership for continued Phase III trials and the market launch of the product.

 

  1. Source: American Congress of Obstreticians and Gynecologists, 2009
  2. Source: Datamonitor, Strategic Perspectives: CNS Disorders in Women, Premenstrual Syndrome/Premenstrual Dysphoric Disorder, 2002

 

 

Contact: Karin Ekberg, CEO | +46 70 458 00 45| karin.ekberg@umecrine.se | www.umecrine.se