Cynapsus Publishes White Paper on Apomorphine for ‘Off’ Periods in Parkinson's Disease and Its Alternative Delivery Development Candidate APL-130277
Marketwire, May 15, 2022
TORONTO – Cynapsus Therapeutics Inc. (CTH: TSX-V), a specialty pharmaceutical company developing the only known orally administered (sublingual) formulation of apomorphine, the only drug approved to treat the immobility (“off”) symptoms of Parkinson’s disease, has completed a white paper providing background clinical information on apomorphine. The paper identifies the potential benefits of APL-130277, the company’s proprietary, patented, sublingual thin-film strip system, specifically its ability to deliver apomorphine to patients in a more convenient and more well-tolerated manner.
Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus, stated: “We have been receiving requests for a more comprehensive, clinically based summary of apomorphine, covering its benefits, drawbacks and known side effects, as well as a summary of our development delivery candidate APL-130277—all in a single document. Accordingly, we have composed this background paper, which is now available on our website. It offers useful information to anyone who is interested in these topics.”
The white paper is titled “Apomorphine for Off Periods in Parkinson's Disease: Clinical Use and Potential of a Developmental Sublingual Formulation, APL-130277”. It summarizes the medical literature on the freezing or “off” episodes experienced by 25 percent to 50 percent of Parkinson’s patients. It goes on to identify how apomorphine works as an acute intermittent rescue treatment. Further, it summarizes some of the most pertinent data from a recent survey of 500 neurologists worldwide regarding the number of patients who will potentially experience these “off” episodes. It then identifies past efforts to find new delivery methods and the benefits of the new APL-130277 sublingual approach. The paper reviews clinical data generated to date and further data expected through the remainder of 2013. It also includes predictions by the 500 neurologists regarding the potential use of the new delivery method by Parkinson’s patients who experience the “off” episodes.
A copy of the full paper is available at the Cynapsus website, www.cynapsus.ca (DOWNLOAD)
The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this press release.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing the only known orally administered (i.e. sublingual) delivery of the only approved drug (apomorphine) to be used as a rescue therapy for “off” motor symptoms of Parkinson’s disease. Apomorphine is currently primarily delivered as an inconvenient and painful subcutaneous injection. Over one million people in the U.S. and an estimated 5 million people globally suffer from Parkinson's disease. Parkinson’s disease is a chronic and progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. Based on a recent study and the results of the Company’s Global 500 Neurologists Survey, it is estimated that between 25 percent and 50 percent of patients experience “off” episodes in which they have impaired movement or speaking capabilities. Current medications only control the disease’s symptoms, and most drugs become less effective over time as the disease progresses. Cynapsus’ drug candidate, APL-130277, is an easy-to-administer, fast-acting reformulation of apomorphine, which is approved in an injection formulation to rescue patients from “off” episodes.
Cynapsus is focused on maximizing the value of APL-130277 by completing pivotal studies in advance of a New Drug Application expected to be submitted in 2015. Cynapsus anticipates a trade sale or out-licensing to an appropriate global pharmaceutical partner before such an application is submitted.
More information about Cynapsus (CTH: TSX‐V) is available at www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.
Contact Information
Cynapsus Therapeutics
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
[email protected]
Andrew Williams
COO & CFO
(416) 703-2449 x253
[email protected]
Forward Looking Statements
This announcement contains "forward-looking statements" within the meaning of applicable Canadian securities legislation. Generally, these forward-looking statements can be identified by the use of forward-looking terminology such as "plans", "expects" or "does not expect", "is expected", "budget", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes" or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might" or "will be taken", "occur" or "be achieved". Forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Cynapsus to be materially different from those expressed or implied by such forward-looking statements, including but not limited to those risks and uncertainties relating to Cynapsus’ business disclosed under the heading “Risk Factors” in its Annual Information Form filed on November 1, 2021 and its other filings with the various Canadian securities regulators which are available online at www.sedar.com. Although Cynapsus has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Cynapsus does not undertake to update any forward-looking statements, except in accordance with applicable securities laws.
-30-
