-- To complete Phase 2b and support Phase 3 initiation for Parkinson’s disease program and pipeline expansion --
CHELSEA, Mass. September 11, 2013 – Civitas Therapeutics, Inc., a biopharmaceutical company with a lead program in Parkinson’s disease that leverages the ARCUS® respiratory delivery platform, today announced the successful completion of a $38 million Series B financing. Bay City Capital led the round and was joined by new investors RA Capital and another undisclosed blue chip public investment fund with participation from all existing investors including Alkermes plc, Canaan Partners, Fountain Healthcare Partners, and Longitude Capital.
“The strength and diversity of this investor group provides a robust foundation for achieving our vision of developing proprietary ARCUS®-based therapeutics to improve outcomes for patients,” said Glenn Batchelder, Chief Executive Officer and Co-founder of Civitas. “We are pleased that our new investors recognized the significant value that has been created since our initial financing, and we are excited to have their input and support as we further develop our lead program along with the broader pipeline.”
Civitas plans to use the proceeds from this financing for late stage clinical development of the company’s lead program, CVT-301, an inhaled formulation of levodopa (L-dopa) being developed for the rapid and reliable relief from debilitating motor fluctuations (OFF episodes) associated with Parkinson’s disease. Civitas recently initiated a Phase 2b clinical study to evaluate the efficacy and safety of CVT-301, self-administered by patients, in treating emergent OFF episodes during one month of continued use. The company will report preliminary data from this study in the first half of 2014. In addition, Civitas will explore additional opportunities to leverage the ARCUS® platform for other disease states where the potential to deliver a large, precise dose of a drug -- independent of inspiratory flow rate -- from a simple, breath actuated device, would provide a significant clinical advantage.
“As we surveyed the Parkinson’s disease landscape, we found CVT-301 to be a particularly compelling opportunity that uniquely addresses a significant unmet need,” said Rajeev Shah, Partner at RA Capital. “CVT-301 represents a rare combination of a large commercial opportunity for a severe disease coupled with a highly de-risked, capital efficient development path.”
“We are very pleased to join the Civitas investor syndicate,” said Rob Hopfner, Partner at Bay City Capital. “Civitas, along with its scientific and patient foundation collaborators, has made impressive achievements in rapidly advancing the development of CVT-301 since the company’s launch in 2011. The company’s track record of outstanding execution gives us confidence that they are destined to deliver important new therapies to patients.”
As part of this financing, Mr. Shah and Dr. Hopfner will join Civitas’ Board of Directors.
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. Oral L-dopa, used for chronic symptom management, is administered to maintain dopamine levels in the brain above the therapeutic threshold; however, the reliability of oral L-dopa formulations is significantly compromised by delayed and unpredictable absorption and excessive variability in circulating plasma drug concentrations inherent to the oral delivery route. L-dopa remains widely recognized as the most efficacious treatment for Parkinson’s disease symptoms in spite of this intrinsic unreliability, which results in OFF episodes. CVT-301 is being developed as an adjunct PRN therapy to standard oral L-dopa therapy to address OFF episodes as they emerge and enable patients to reliably manage their symptoms.
CVT-301 leverages the ARCUS® platform to optimally deliver a precise dose to the deep lung for rapid and predictable L-dopa absorption. The ARCUS® 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 recently completed 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 at all doses tested. Civitas is currently conducting a Phase 2b study to evaluate the efficacy and safety of CVT-301 in treating emergent OFF episodes during one month of continued use. CVT-301 clinical studies conducted to date have been funded in part by grants from The Michael J. Fox Foundation for Parkinson’s Research.
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 diminished production of dopamine in the substantia nigra area of the brain, 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® Platform
The ARCUS® 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® 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, Mass. in a facility that includes both development and commercial scale GMP manufacturing capabilities. The Company is financed by leading investors including Alkermes plc, Bay City Capital, Canaan Partners, Fountain Healthcare Partners, Longitude Capital and RA Capital. For further information on Civitas, please visit www.civitastherapeutics.com.