Cynapsus Announces Positive Proof of Concept Results in Animals for Parkinson’s Drug Candidate
Marketwire, December 2, 2021
TORONTO, CANADA – Cynapsus Therapeutics Inc. (“Cynapsus”) (formerly Cannasat Therapeutics Inc.) (CTH: TSX-V) is providing today an update on the progress of its research activities on its lead drug candidate, APL 130277, a potential treatment for patients with Parkinson’s disease.
Anthony Giovinazzo, the President & CEO of Cynapsus, said, “Management’s goal was to complete proof-of-concept studies comparing prototypes of APL-130277 to injectable apomorphine by the end of the year. I am pleased to report that we have successfully completed these studies ahead of schedule, with positive results. The achievement of this important milestone is crucial, as we believe these results have significantly de-risked the project, from the perspective of a sublingual thin film-strip delivering drug to the blood stream in appropriate quantities and time. In addition to our formulation optimization efforts, we will now be working towards a pre-IND Meeting with the USFDA in H1 2011, and expect to file an IND and complete our first in man study by the end of 2011. As this is a new delivery method of an approved drug, we continue to pursue a shortened regulatory path that could see a new drug application being submitted in H2 2013 or early H1 2014.”
Highlights of the results include:
• Cynapsus has demonstrated that its thin-strip prototypes dissolve rapidly under the tongue in a reasonable period of time achieving the targeted Tmax. Optimization of the formulation is focused on improving the control of the rate of dissolution.
• Cynapsus has shown that its thin-strip prototypes deliver appropriate quantities of drug to the blood stream achieving targeted AUC and Cmax. Cynapsus has achieved blood levels and a pharmacokinetic (PK) profile that are very similar to the FDA-approved injectable delivery of apomorphine hydrochloride. This is important as it supports our premise that patients are looking for similar or improved efficacy with improved delivery and convenience (i.e. patients will prefer film strip vs. injection).
In preparation for the pre-IND meeting, the company has also established a GMP Active Pharmaceutical Ingredient (API) supply. Cynapsus has established an agreement with a multinational Good Manufacturing Practices (GMP) drug manufacturer for supply of USP-grade apomorphine.
These results are in-line with a USFDA 505(b)(2) (accelerated approval pathway) development strategy and provide a key link to the use of reference safety and efficacy data from the FDA approved product. The results also complement Cynapsus’ recently announced survey results (See November 8, 2021 Press Release) forecasting favourable acceptance of APL 130277 by United States Health Maintenance Organizations (HMO) and Insurers, as well as an attractive range of pricing for the product from a reimbursement perspective.
Recent Survey Results
The survey of 11 large US payers (HMO and insurers) gauged the opinion and acceptance onto formulary of APL 130277, Cynapsus Therapeutics’ oral thin film formulation of apomorphine for the treatment of Parkinson’s disease. The results indicate that APL 130277 may be readily accepted on formulary by payers and reimbursed at price levels at or near the level at which apomorphine injection is currently reimbursed.
Highlights include:
• Over 90% of respondents would reimburse APL 130277 within 3 months of approval of the drug by the FDA
• Nearly 75% of respondents would reimburse APL 130277 at an average wholesale price (AWP) equal to apomorphine injection.
• Almost 70% of respondents would be willingly to accept a broader use of the drug if their review showed better treatment outcomes and other cost savings from use of APL 130277 versus currently available injections of apomorphine.
• Nearly 50% of respondents would accept a price premium on APL 130277 of 25% over the cost of apomorphine injection provided it is as effective and provided any single additional benefit, such as a reduced hospital stay, prevention of re-hospitalization, delayed progression of disease or need for surgical intervention.
The results from this payer survey confirm that payers would be willing to accept acquisition costs and reimburse at levels similar to apomorphine injection. Furthermore, they would be willing to reimburse for late stage/severe Parkinson’s’ patients and a larger subset of earlier stage Parkinson’s patients if the clinical results show efficacy and improved associated healthcare outcomes.
Previous Neurologist Survey Results
This survey complements a prior Neurologist survey (See July 27, 2022 press release) where more than 50 Movement Disorder Specialists representing more than 12,000 patients, would consider prescribing APL 130277 to their patients as it has increased convenience and safety. More importantly, these Neurologists would consider using APL 130277 in up to 7 times more cases, including more mild and moderate patients than currently treated with the injectable drug, as they believed it would lead to better health outcomes.
The TSX Venture Exchange Inc. has not reviewed and does not accept responsibility for the adequacy or accuracy of this press release.
About Cynapsus Therapeutics
Cynapsus is a specialty clinical development pharmaceutical company targeting diseases of the brain. Cynapsus has a lower risk Parkinson’s drug candidate (“APL-130277”), which is a reformulation of an approved drug. APL-130277 is designed to address a much larger moderate to severe patient population, which represents close to 50% of Parkinson’s patients. Cynapsus also has a proprietary formulation technology for cannabinoid drug candidates, which may be used to treat neuropathic pain associated with multiple sclerosis and cancer, as well as for nausea/vomiting and appetite stimulation.
Cynapsus’ strategy is to grow its portfolio of drug candidates through in-licensing and acquisitions, and to advance projects to Phase 2 proof-of-concept clinical studies. Once the drug candidates are sufficiently de-risked, Cynapsus intends to out-license the programs to the appropriate pharmaceutical marketing partners for a combination of upfront, milestone, and royalty payments.
More information about Cynapsus (CTH: TSX-V) is available at www.cynapsus.ca.
About APL 130277
Cynapsus is developing APL 130277 as a convenient and fast acting reformulation of FDA-approved apomorphine (a proven dopamine agonist that addresses motor fluctuation for Parkinson’s patients). APL 130277 is a reformulation of the currently marketed injection into an oral formulation that will follow an expedited clinical development path of 18-24 months based on the FDA’s 505b(2) submission process. In addition to addressing the needs of severe Parkinson’s patients who currently have access to only the inconvenient and painful subcutaneous apomorphine injection, APL 130277 has the potential to become adjunctive therapy for moderate Parkinson’s patients as well. APL 130277 could be used 2 to 3 times daily to allow for a fast rescue of patients experiencing motor fluctuations in addition to therapy with various forms of levodopa.
Contact Information
Anthony Giovinazzo
President & CEO
W: (416) 703 2449 (Ext. 225)
[email protected]
Andrew Williams
COO & CFO
W: (416) 703-2449 (Ext. 253)
[email protected]
Forward Looking Statements
This press release 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 Cynapsus' current Annual Information Form 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.
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