Civitas Therapeutics has announced positive results from a Phase 2b trial of its CVT-301 inhaled L-dopa for the treatment of Parkinson’s disease symptoms. The company is developing CVT-301 based on its proprietary ARCUS particle engineering and dry powder inhaler technology.
The randomized, double-blind study involved 86 Parkinson’s patients at multiple study centers. The patients self-administered CVT-301 to treat up to three “OFF episodes” per day. During OFF episodes, Parkinson’s patients have decreased mobility and may completely lose the ability to move. According to Civitas, the study demonstrated the drug’s safety and effectiveness and also that patients were able to successfully use the ARCUS inhaler while in the OFF state.
Civitas President and CEO Mark Iwicki said, “We are extremely pleased that we met our primary endpoints in our Phase 2b trial with statistical significance, demonstrating that CVT-301 was safe and well tolerated and provides patients with a rapid, clinically important improvement in motor function. CVT-301 provided onset of action by 10 minutes with durable effects lasting for at least 60 minutes. CVT-301 is being developed to address a significant unmet need facing Parkinson’s disease patients today, and these results, particularly the efficacy and ease-of-use seen in the outpatient setting, give us confidence that CVT-301 can have a transformative impact on the daily lives of patients.”
Read the Civitas Therapeutics press release.
Read an OINDPnews feature article on Civitas and CVT-301
