Umecrine Cognition AB, part of the portfolio of Stockholm, Sweden-based firm Karolinska Development today announces the enrollment of the first patient in a clinical Phase 2a study with the lead compound GR3027 in patients with idiopathic hypersomnia.
The objectives of the study (protocol UCAB-CT-03) are to assess the safety and pharmacokinetics and to evaluate the exploratory efficacy of GR3027 in patients with idiopathic hypersomnia.
Idiopathic hypersomnia is a severe orphan disease characterized by chronic excessive daytime sleepiness. It is a lifelong debilitating condition with a profound effect on the patient’s quality of life. There are no approved treatments for idiopathic hypersomnia but several wake-promoting treatments are used off-label.
GR3027, in clinical development for hepatic encephalopathy and sleep disorders, is a GABAA receptor modulating steroid antagonist (GAMSA) designed to antagonize GABAA receptor activation by endogenous neuroactive steroids. GR3027 has been shown to restore different types of neurological impairments including cognitive and sleep alternations in experimental models. The drug candidate enters the CNS and reverses the inhibitory effects of the neurosteroid allopregnanolone on brain function in humans. Collectively, these findings strongly implicate that GR3027 is a promising novel treatment for a wide range of cognitive and sleep disorders.
“Excessive daytime sleepiness is a major concern from a medical and public health point of view, with a global prevalence of approximately 20%,” says Magnus Doverskog, CEO of Umecrine Cognition, in a release. “We are excited to start exploring GR3027 in patients with idiopathic hypersomnia, a subset of patients with lifelong chronic sleeping disorders that severely affect their lives.”