Civitas Therapeutics has announced positive results from a Phase 1 clinical study of its CVT-301 inhaled dry powder formulation of levodopa (L-dopa) for the treatment of Parkinson’s disease. According to the company, the study showed that all of the doses tested were well tolerated, and sufficient plasma levels of L-dopa were achieved in healthy volunteers who inhaled CVT-301. The study was partially funded by a grant from the Michael J. Fox Foundation.
Civitas co-founder and Chief Medical Officer Martin Freed explained, “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. 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.”
“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,” commented Civitas advisory board member Karl Kieburtz of the University of Rochester.
CVT-301 is a non-carrier formulation using large porous particles created using Civitas’s proprietary ARCUS technology. The ARCUS system uses a breath-actuated DPI for delivery.
Read the Civitas press release.
