Positive topline results from Civitas' CVT-301 Phase 1 trial on PD

Civitas Therapeutics, Inc., a privately-held pharmaceutical company developing transformative therapeutics using the ARCUS^(TM) respiratory delivery platform, announced today positive topline results from a Phase 1 clinical trial for CVT-301, an inhaled formulation of levodopa (L-dopa) for the rapid relief from motor fluctuations associated with Parkinson's disease.

The Phase 1 study showed that 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. Immediate absorption and dose proportional pharmacokinetics were seen across all doses tested. In addition, all doses tested of CVT-301 were safe and well tolerated. Civitas plans to present comprehensive data from the Phase 1 study at a future scientific meeting.

"Due 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," said Dr. Martin Freed, Chief Medical Officer and co-founder of Civitas. "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."

This 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. By delivering L-dopa through the pulmonary route, CVT-301 is being evaluated as an intermittent adjunct therapy with the potential to produce rapid, consistent and durable relief from debilitating motor fluctuations associated with Parkinson's disease.

"As expected, the tolerability of CVT-301 and L-dopa pharmacokinetic profile behaved consistently with the other molecules we have taken into the clinic over the last decade with the ARCUS^(TM) platform," said Dr. Richard Batycky, Chief Scientific Officer and co-founder of Civitas. "Our technology's proven unique ability to deliver a large precise dose with an immediate onset should enable Parkinson's patients to abort 'off' episodes and thereby helping to avoid debilitating disruptions in their lives."

"I am encouraged to see that CVT-301 appeared to be so well tolerated and safe in this initial study. By essentially eliminating the significant absorption lag time associated with oral L-dopa, and by predictably delivering clinically relevant plasma levels, this data provides a very favorable and unprecedented profile for a self-administered L-dopa therapy," said Dr. Karl Kieburtz, the Robert J. Joynt Professor of Neurology, University of Rochester, and a member of the Civitas Scientific Advisory Board.