Clexio is developing CLE-600, a pill for the treatment of Parkinson’s disease nocturnal symptoms and Early Morning OFF.
CLE-600 is a new investigational drug that has not been approved for commercial distribution.
Parkinson’s disease (PD) develops as dopamine-producing nerve cells in an area of the brain that controls movement gradually die. The reduced synthesis of dopamine causes the movement problems characteristic to Parkinson’s: stiffness, tremors, and difficulty with balance and coordination occurring during the day and night. PD is the second-most common neurodegenerative disease after Alzheimer’s disease, with US prevalence estimated at ~1M individuals.
One common struggle for Parkinson’s patients is troubled nights and morning akinesia (loss of ability to move your muscles voluntarily). Estimates show nocturnal symptoms and Early Morning Akinesia/OFF (EMO) to be prevalent in more than 60% of Parkinsonian patients, reducing patients’ quality of life and daytime function.
Current available dopaminergic treatments do not cover the duration and levels required for clinical efficacy along the entire night.
I don’t remember sleeping through the night for a number of years
I have so much trouble falling asleep!! And after all that I wake at 4 am and can’t get back to sleep
CLE-600 is designed to achieve stable and prolonged levels of Levodopa, used as first-line treatment to replace dopamine in Parkinson’s patients for decades. CLE-600 aims to control patient symptoms during the night and into the early morning. CLE-600 uses Clexio’s proprietary Oral Long Acting Release (OLAR®) drug delivery platform.
Two Phase 1 studies were completed. Studies found that the administration of CLE-600 was safe and well tolerated, and a prolonged Levodopa pharmacokinetic profile was achieved.
The company is now planning for the first study in patients with Parkinson’s disease.