Civitas Therapeutics, Inc., a privately-held pharmaceutical company developing transformative therapeutics using the ARCUS(TM) respiratory delivery platform, announced today that the Company will make its first public presentation at the Sixth Annual Parkinson's Disease Therapeutics Conference, sponsored by The Michael J. Fox Foundation for Parkinson's Research, to be held on October 24th in New York City. Martin Freed, MD, Chief Medical Officer and co-founder of Civitas, will present the CVT-301 Phase 1 study results. CVT-301 is an inhaled levodopa (L-dopa) formulation, being developed to provide rapid alleviation of intermittent motor fluctuations ("off" episodes) associated with Parkinson's disease.
“By enabling patients to rapidly and consistently increase their L-dopa plasma levels as they sense 'off' symptoms, CVT-301 has the potential to dramatically improve their ability to reliably manage their symptoms and regain control of their daily lives.”
"While L-dopa remains the most effective and widely used symptomatic agent for Parkinson's disease, the significant intrinsic variability of the conventional oral administration of L-dopa contributes to unpredictable 'off' episodes that have a devastating impact on patients' lives," said Dr. Freed. "By enabling patients to rapidly and consistently increase their L-dopa plasma levels as they sense 'off' symptoms, CVT-301 has the potential to dramatically improve their ability to reliably manage their symptoms and regain control of their daily lives."
The Phase 1 study in healthy volunteers evaluated the safety, tolerability and L-dopa pharmacokinetic profile across a range of doses of CVT-301 delivered using Civitas' proprietary, simple handheld breath- actuated inhaler. The study showed that inhaled delivery of CVT-301 achieved therapeutic L-dopa plasma levels within five minutes of administration with unprecedented precision. Consistent and dose proportional pharmacokinetics were seen across all doses tested. In addition, all doses tested of CVT-301 were observed to be safe and well tolerated. In the context of extensive clinical experience correlating L-dopa plasma levels to symptomatic relief, the CVT-301 Phase 1 clinical study results represent pharmacokinetic clinical proof of concept.
CVT-301 is being developed as an adjunct to standard oral L-dopa therapy to enable patients to manage motor fluctuations caused in part by the inter-dose variability of oral L-dopa. Civitas anticipates reporting topline results from the ongoing CVT-301 Phase 2a double blind placebo controlled study in Parkinson's disease patients in early 2013. Both the Phase 1 and Phase 2a study were funded in part by a grant from The Michael J. Fox Foundation for Parkinson's Research.