Civitas Therapeutics has reported positive results from a Phase II trial of CVT-301, an inhaled L-dopa for Parkinson's disease.
CVT-301 is being developed as an adjunct therapy to provide relief from intermittent debilitating motor fluctuations (OFF episodes) that impact a large proportion of Parkinson's disease patients.
The Michael J Fox Foundation for Parkinson's Research CEO Dr Todd Sherer said; "The unpredictable wearing off of oral L-dopa and the dyskinetic side effects are among the most significant challenges with the current management of Parkinson's disease."
The randomised, placebo-controlled study evaluated L-dopa pharmacokinetics and pharmacodynamic effects after administration of CVT-301 to Parkinson's disease patients with motor fluctuations.
A rapid and durable improvement in motor function was observed with the CVT-301 administration in patients in the OFF state.
The CVT-301 provided immediate L-dopa absorption and consistent increases in plasma concentrations, in marked contrast to the delayed and variable L-dopa levels seen with Sinemet (oral L-dopa/carbidopa), according to the data.
No increase in the frequency or severity of dyskinesias relative to oral was observed, and all doses of CVT-301 were safe and well-tolerated.
Civitas chief medical officer and co-founder Dr Martin Freed said the significant inherent variability of oral L-dopa absorption is known to contribute to the development of debilitating OFF episodes.
"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," Freed said.
Image: A Lewy body (stained brown) in a brain cell of the substantia nigra in Parkinson's disease. The brown colour is positive immunohistochemistry staining for alpha-synuclein. Photo: Marvin 101.