Chelsea, MA – Civitas Therapeutics, Inc., a biopharmaceutical company developing transformative therapeutics using the ARCUS(TM) respiratory delivery platform, today announced it has been selected to receive a second grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF). The $1 million grant will support a Phase 2b clinical trial of CVT-301, an inhaled formulation of levodopa (L-dopa). CVT-301 is being developed as an adjunct PRN (as needed) therapy to provide rapid and reliable relief from intermittent debilitating motor fluctuations (OFF episodes) that impact a large proportion of Parkinson’s disease patients.
“The enthusiasm and support of MJFF for CVT-301 has been extraordinarily valuable in our efforts. In addition to its financial contributions, the Foundation’s ability to help connect us with patients, thought leaders and other important stakeholders has contributed to our rapid progress,” said Rick Batycky, Ph.D., Founder and Chief Scientific Officer of Civitas. “We receive consistent feedback that our simple product configuration is uniquely suited for this patient population and this furthers our confidence that CVT-301 has the potential to provide a transformative benefit to those suffering from this devastating disease.”
Civitas recently announced positive top-line results from a Phase 2a clinical trial that showed that CVT-301 administered in the OFF state produced a rapid and durable improvement in motor function in study participants. All doses of CVT-301 tested were generally safe and well tolerated. These results have also provided the basis for dose selection for the Phase 2b trial. Civitas intends to present the comprehensive data from the Phase 2a study at a future scientific meeting.
“We are encouraged by the progress achieved to date by Civitas in their effort to address the unpredictable and debilitating OFF episodes associated with the variability of oral L-dopa administration,” said Alison Urkowitz, Vice President of Research Programs at MJFF. “We are hopeful that the Civitas therapy can play a key role in addressing this unmet need for Parkinson’s patients and are pleased to continue our support of CVT-301 as the therapy undergoes continued human clinical trials.”
Civitas’ lead program, CVT-301, is an inhaled formulation of L-dopa being developed for the rapid and reliable relief from debilitating motor fluctuations (OFF episodes) associated with Parkinson’s disease. For chronic symptomatic management, oral L-dopa is administered to maintain dopamine levels in the brain above the therapeutic threshold; yet the reliability of oral L-dopa is significantly compromised by delayed and unpredictable absorption and excessive variability in the circulating plasma drug concentrations inherent to the oral delivery route. Oral L-dopa remains widely recognized as the most efficacious treatment of Parkinson’s disease symptoms in spite of this intrinsic unreliability and the resulting OFF episodes. CVT-301 is being developed as an adjunct PRN therapy to standard oral L-dopa therapy to address the OFF episodes as they emerge and enable patients to reliably control their symptoms. CVT-301 is an ARCUS(TM) therapeutic that incorporates L-dopa and is optimized to deliver a precise dose to the deep lung for rapid and predictable L-dopa absorption. The ARCUS(TM) platform is uniquely able to deliver the necessary L-dopa dose with the required precision. A Phase 1 study in healthy volunteers showed that CVT-301 rapidly achieved target L-dopa plasma levels with a pharmacokinetic (PK) profile supportive of its therapeutic potential. The Phase 2a double blind placebo controlled dose finding study (CVT-301-002) recapitulated the PK profile in patients, produced rapid and durable improvement in motor function when administered to patients in the OFF state, and was generally safe and well tolerated in all doses tested.
About Parkinson’s Disease
Over one million people in the US and six million people worldwide suffer from Parkinson’s disease, a neurodegenerative disorder caused by the diminished production of dopamine, resulting in progressive impairment of motor function including tremors, rigidity, and difficulty in moving. The unreliability of available medications for symptomatic treatment of Parkinson’s disease remains a significant unmet need. Even when treated with the current standard of care, the majority of Parkinson’s patients continue to experience motor fluctuations. These unpredictable OFF episodes reduce patients’ ability to lead productive, independent lives and are recognized by patients, care givers, and healthcare professionals as one of the most troubling and debilitating issues associated with the disease.
About ARCUS(TM) Platform
The ARCUS(TM) platform is a proprietary dry powder and device combination with a unique ability to deliver a large, precise dose independent of inspiratory flow rate from a simple, breath actuated device. The platform is protected by a large intellectual property estate including over 130 issued patents. The technology has successfully delivered more than one million doses to patients and the manufacturing technology has been scaled to accommodate a significant commercial launch.
About Civitas Therapeutics
Civitas is a privately-held biopharmaceutical company focused on developing a robust pipeline of inhaled therapeutics with the clinically proven ARCUS(TM) dry powder pulmonary delivery platform. In addition to the lead program, CVT-301 for treating Parkinson’s disease, other programs encompass respiratory disease, central nervous system disorders, and infectious disease. The company is headquartered in Chelsea, MA in a facility that includes both development and commercial scale GMP manufacturing capabilities. The Company is financed by leading investors including Canaan Partners, Fountain Healthcare Partners, Longitude Capital and Alkermes plc. For further information on Civitas, please visit www.civitastherapeutics.com.
About the Michael J. Fox Foundation for Parkinson’s Research
As the world’s largest private funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $325 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.