Chelsea, MA — Civitas Therapeutics, Inc., a privately-held biopharmaceutical company developing and commercializing transformative therapeutics using its proprietary ARCUSTM technology, today announced the successful completion of a $55 million Series C financing. The financing round included new investors Adage Capital Management, LP, OrbiMed Advisors, Partner Fund Management, LP, Rock Springs Capital, and Sofinnova Ventures, with participation from all existing investors, including Alkermes plc, Bay City Capital, Canaan Partners, Fountain Healthcare Partners, Longitude Capital, RA Capital, and Wellington Management Company, LLP.
“The proceeds from this financing round will be used towards the upcoming Phase 3 clinical trials for our lead candidate, CVT-301, an inhaled formulation of levodopa (L-dopa) being developed for rapid and reliable relief from debilitating motor fluctuations, known as OFF episodes, associated with Parkinson’s disease (PD), as well as for the development of additional, early stage pipeline programs,” said Mark Iwicki, President and Chief Executive Officer of Civitas Therapeutics. Civitas intends to initiate the pivotal Phase 3 clinical trial for CVT-301 in early 2015, and expects data to be reported in 2016.
CVT-301 is being developed as a self-administered, adjunctive, as needed, inhaled L-dopa therapy for OFF episodes, providing rapid delivery of L-dopa to the brain to be used in conjunction with a PD patient’s individually optimized oral L-dopa regimen. CVT-301 leverages Civitas’ proprietary ARCUS™ technology which enables the delivery of a precise dose to the lung to potentially enable rapid and predictable L-dopa absorption through a reusable, pocket-size, breath-actuated inhaler.
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 and OFF Episodes
Over one million people in the US and between seven and ten million people worldwide suffer from PD. PD is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine, and is characterized by symptoms including tremors at rest, rigidity and impaired movement. The standard of care for the treatment of PD symptoms is oral levodopa (L-dopa). Oral dosing of L-dopa is associated with wide variability in the timing and amount of L-dopa absorption into the bloodstream leading to the unreliable control of symptoms resulting in the emergence of OFF episodes. These OFF episodes, which increase in frequency and severity during the course of the disease, are experienced by a majority of PD patients and are considered one of the greatest unmet medical needs facing PD patients today.
About ARCUS™ Technology
Our proprietary ARCUS™ technology, the basis of CVT-301, allows for the consistent and precise delivery of large quantities of drug per inhalation in a simple, patient-friendly, breath-actuated inhaler. The technology delivers a consistent dose to the lung every time across a wide range of patient inhalation flow rates. The technology has been used to successfully deliver more than one million doses to patients in clinical trials. We have a robust patent portfolio relating to CVT-301 and our ARCUS™ technology which covers, among other things, important aspects of the formulated drug product, the inhaler, the method of delivery of drug and the manufacturing processes for CVT-301.
About Civitas Therapeutics
Civitas is a biopharmaceutical company focused on developing and commercializing transformative therapeutics using its proprietary ARCUS™ technology, with an initial focus on treating OFF episodes in patients with Parkinson’s disease. Civitas is financed by leading investors including Alkermes plc, Bay City Capital, Canaan Partners, Fountain Healthcare Partners, Longitude Capital, RA Capital, Wellington Management Company, LLP, Adage Capital Management, LP, OrbiMed Advisors, Partner Fund Management, LP, Rock Springs Capital, and Sofinnova Ventures.