Cynapsus Therapeutics Enrolls First Patient in Pivotal Phase 3 Safety Study of APL-130277 for the Treatment of OFF Episodes in Patients with Parkinson's Disease
September 2, 2021
The Phase 3 Safety Study and the Ongoing Phase 3 Efficacy Study will Form the Basis for the Expected NDA Submission Near the End of 2016
TORONTO – Cynapsus Therapeutics Inc. (NASDAQ: CYNA) (TSX: CTH) (the “Company”) today announced enrollment of the first patient in the CTH-301 clinical trial, a pivotal Phase 3 study to examine the safety and tolerability of APL-130277 for the acute treatment of OFF episodes in patients with Parkinson's disease (PD). CTH-300, a pivotal Phase 3 efficacy study, is also ongoing with data expected from both trials in 2016.
Dr. Albert Agro, Chief Medical Officer of Cynapsus, stated, “Enrolling the first patient in the CTH-301 safety study is a significant milestone for Cynapsus. The design and endpoints for this study were based on an End-of-Phase 2 meeting with the FDA earlier this year. The CTH-301 study, together with the CTH-300 efficacy study, will form the basis for our expected NDA submission near the end of 2016. We believe that apomorphine, the only approved drug to rapidly treat OFF episodes, combined with our sublingual film delivery technology, could provide many patients with a rapid, reliable means of turning ON from the OFF state.”
The CTH-301 trial is a 6-month, open-label, single arm safety study in PD patients who have at least one OFF episode every 24 hours, with total OFF time of at least two hours per day. The primary endpoint for the study is the safety and tolerability of APL-130277 in patients with PD. The secondary endpoints examine efficacy variables including the change in the MDS-UPDRS Part III scores over the 6-months of treatment. Sites will recruit patients over several months, with each patient being evaluated for six months. An estimated 226 patients will be enrolled, including up to 126 who had been enrolled in the CTH-300 efficacy study and rolled over to this study, plus an additional 100 new patients.
For additional information about the CTH-301 trial and to learn more about eligibility, patients can visit https://www.clinicaltrials.gov/
Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus, said, “Approximately 400,000 people with PD in the U.S. experience debilitating OFF episodes. When PD patients experience an OFF episode, they are often unable to perform simple daily tasks such as eating, bathing and dressing, thus becoming increasingly dependent on caregivers. We believe that APL-130277 can, if approved, change the way a large number of patients around the world manage OFF episodes. While we expect to have 12 weeks of safety data from the CTH-300 efficacy study in early to mid 2016, the 6-month data from the CTH-301 safety study will provide a much more robust assessment of safety. ”
About Cynapsus
Cynapsus is a specialty Central Nervous System pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand turning ON of debilitating OFF episodes associated with PD. The Company recently completed a Phase 2 clinical trial for its lead product candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or apomorphine. Apomorphine is the only molecule approved for acute, intermittent treatment of OFF episodes for advanced PD patients, but is currently only approved as a subcutaneous injection in the United States. APL-130277 is a “turning ON” medication designed to rapidly, safely and reliably convert a PD patient from the OFF to the ON state while avoiding many of the issues associated with subcutaneous delivery of apomorphine. It is designed to convert all types of OFF episodes, including morning OFF episodes, often considered the most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in the United States, and the Company intends to submit a new drug application in 2016.
Contact Information
Company Contacts:
Cynapsus Therapeutics
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
[email protected]
Cynapsus Therapeutics
Andrew Williams
COO & CFO
(416) 703-2449 x253
[email protected]
Investor Contact:
The Trout Group
Marcy Nanus
Senior Vice President
(646) 378-2927
[email protected]
Media Contact:
Russo Partners LLC
Matt Middleman
(212) 845-4272
[email protected]
Forward-Looking Statements
This announcement contains "forward-looking statements" within the meaning of applicable securities laws, including, without limitation, the expected completion of the CTH-300 and CTH-301 Phase 3 studies of APL-130277 in mid to late 2016, and an NDA submission of APL-130277 in 2016. These forward-looking statements include information about possible or assumed future results of the Company’s business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. These forward-looking statements are based on the Company’s current expectations and beliefs and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ from those anticipated in such forward-looking statements as a result of risks and uncertainties, and include, but are not limited to, those factors identified under the caption “Risk Factors” in the Company’s Form 10-Q filed with the United States Securities and Exchange Commission (the “SEC”) on August 14, 2021 and its other filings and reports in the United States with the SEC available on the SEC’s web site at www.sec.gov, and in Canada with the various Canadian securities regulators, which are available online at www.sedar.com. Furthermore, unless otherwise stated, the forward-looking statements contained in this press release are made as of the date of this press release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, changes or otherwise, except as required by law.
Neither the NASDAQ nor the TSX has approved or disapproved of the contents of this press release.
***
