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news.Civitas Therapeutics, known for developing transformative therapeutics using the ARCUS respiratory delivery platform, has reported positive data from a Phase 1 clinical trial for CVT-301 in Parkinson's disease.
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CVT-301 is an inhaled formulation of levodopa (L-dopa) for the rapid relief from motor fluctuations associated with Parkinson’s disease.
In the trial, CVT-301 achieved sufficient plasma levels of L-dopa through inhaled delivery to the lung, resulting in a pharmacokinetic profile that supports its therapeutic potential.
Moreover, immediate absorption and dose proportional pharmacokinetics were seen across all doses tested.
All doses tested of CVT-301 were found to be safe and well tolerated.
Civitas chief medical officer and co-founder Martin Freed said owing to the unpredictability of oral L-dopa, the therapeutic rationale for using inhaled L-dopa to manage motor fluctuations in Parkinson’s disease was intuitive but until now was technically impractical.
"The Phase 1 data demonstrate the transformative potential of CVT-301 to enable patients to better manage their motor symptoms in light of the extensive clinical experience correlating L-dopa plasma levels to symptomatic relief documented over the past 40 years," Freed added.