Alkermes ($ALKS) spinout Civitas Therapeutics today reported positive topline results from a Phase II clinical trial of its Parkinson's drug CVT-301, which uses a respiratory delivery system to provide quick relief to patients experiencing motor fluctuations common to long-term treatment of the disease.
The study used a randomized, placebo-controlled design to evaluate L-dopa effects on patients experiencing motor fluctuations, which can occur when patients use levodopa (Sinemet, Madopar, Co-careldopa or Co-beneldopa) for a long period of time. After long-term use of levodopa--which is meant to give patients smooth and even control of their systems--the drug can become less effective, according to the Parkinson's Disease Society.
Administering CVT-301 to 24 patients in the 'off' state--when they were experiencing motor fluctuations--produced a strong improvement in motor function. The new data reinforces the company's Phase I study results, which showed CVT-301 provided immediate L-dopa absorption--known to be a major contributor to the development of debilitating 'off' episodes--as well as increases in plasma concentrations compared to the delayed and variable L-dopa levels experienced in patients that take Sinemet, the standard therapy for Parkinson's.
"CVT-301 has the potential to provide a transformative benefit to patients by enabling more predictable and effective symptomatic relief without worsening side effects such as dyskinesia, thereby allowing them to regain control of their lives," Dr. Martin Freed, chief medical officer and co-founder of Civitas, said in a statement.
Up to 50% of patients on levodopa for 5 years experience motor fluctuations and dyskinesia, representing a highly unmet need in Parkinson's treatment.
The company reports that all doses of CVT-301 were safe (placebo, 25 mg and 50 mg) and well tolerated with no increase in the frequency or severity of dyskinesias, or involuntary movements.
Civitas--backed by Longitude Capital, Canaan Partners and Fountain Healthcare Partners--licensed the ARCUS respiratory drug delivery technology from Alkermes, which acquired the technology from a startup cofounded by MIT's Bob Langer. The company said it plans to present the full data from the study at a future scientific meeting.
- here's the press release