(CYNA) APL-130277 Improved Parkinson’s Symptoms
Data Presented at the International Congress of Parkinson’s Disease and Movement Disorders APL-130277, Sublingual Apomorphine, for On-Demand Treatment of OFF Episodes Associated with Parkinson’s Disease
TORONTO, ONTARIO–(June 25, 2015) – Cynapsus Therapeutics Inc. (NASDAQ:CYNA)(TSX:CTH) (the “Company”) today announced that it presented data from clinical trials of APL-130277, a sublingual apomorphine thin film under development for the on-demand treatment of OFF episodes associated with Parkinson’s disease (PD). Data from the Company’s CTH-105, CTH-104 and CTH-103 clinical studies, presented at the 19th International Congress of Parkinson’s Disease and Movement Disorders (MDS) in San Diego, California, showed APL-130277 significantly improved PD symptoms (as measured by MDS-UPDRS Part III), rapidly turned patients from the OFF to ON state and was generally safe and well tolerated.
“Phase 1 and Phase 2 data presented at the Congress demonstrated that APL-130277 can achieve the appropriate apomorphine plasma levels needed to rapidly and reliably convert a patient from the OFF to the ON state. In addition, APL-130277 was safe and effective for the acute treatment of OFF episodes in PD patients,” said Jordan Dubow, M.D., Vice President, Medical Affairs, Cynapsus Therapeutics. “These data lead in to our Phase 3 pivotal studies to assess the efficacy, safety and tolerability of APL-130277 for the acute, on-demand management of OFF episodes.”
Presentations at MDS included:
- Efficacy of Sublingual Apomorphine (APL-130277) for the Treatment of OFF Episodes in Patients with Parkinson’s disease; Hauser et al.
- CTH-105 was a Phase 2 open-label multicenter study in which APL-130277 was assessed in 19 patients with PD who experienced OFF episodes, with a total duration of at least two hours of OFF episodes daily.
- Of the 19 total patients dosed, 15 achieved a full ON response. Of the four non-responders, two were dosed incorrectly and two were dosed up to the maximum available dose (30mg).
- Sublingually administered APL-130277 rapidly converted PD patients from the morning OFF state to the full ON state with 100% of responders turning fully ON within 30 minutes and 40% within 15 minutes.
- APL-130277 provided, rapid, clinically meaningful and statistically significant improvement in motor function as assessed by MDS-UPDRS Part III score at all time points assessed (i.e. 15, 30, 45, 60 and 90 minutes) with a mean maximal improvement of 18.9 points in the intent to treat population.
- Thirteen of the 15 patients that turned ON remained ON for at least 30 minutes, nine of whom remained ON for at least 60 minutes, with a mean duration of ON of over 50 minutes.
- The percentage change in MDS-UPDRS Part III was approximately 30% or greater at all time points measured, with a maximum mean percentage change at any time point of 45.6% for the intent to treat population. Mean percentage change of approximately 30% is generally considered a clinically meaningful level at which point patients turn ON.
- Safety of Sublingual Apomorphine (APL-130277) for the Treatment of OFF Episodes in Patients with Parkinson’s disease; Isaacson et al.
- In the CTH-105 study, a total of 77 doses of APL-130277 were administered to the 19 patients who completed dosing.
- APL-130277 was safe and well-tolerated by all of the PD patients in the study.
- Rates of adverse events (AEs) were similar to other dopamine agonists.
- There were no related serious AEs, no AEs of local oral mucosal irritation, and no subjects discontinued due to an AE or any other reason.
- Pharmacokinetics, Safety and Tolerability of High-dose Sub-lingually Administered APL-130277 in Healthy Volunteers; Agro et al.
- CTH-104 was a single-center, Phase 1 study that evaluated the pharmacokinetic (PK) profile, safety and tolerability of a single dose of APL-130277 25mg in healthy volunteers. Eleven subjects were dosed with APL-130277 25mg and two with placebo.
- In healthy volunteers, the higher dose of APL-130277 (25mg) administered sublingually demonstrated a favorable PK profile to support a rapid and sustained effect for acute relief of OFF episodes in PD patients.
- Time to reach the known minimum efficacious plasma apomorphine concentration was achieved in under 10 minutes and apomorphine levels were maintained above this concentration for over 2.5 hours.
- PK results demonstrated dose proportionality to lower doses and the PK curve remained rounded.
- The AEs reported were mild to moderate in severity with no serious AEs.
- Pharmacokinetics, Safety and Tolerability of Sublingually Administered APL-130277 Compared to Subcutaneous Apomorphine in Healthy Volunteers; Agro et al.
- CTH-103 was a single-center, Phase 1 crossover study that evaluated the PK profile, safety and tolerability of two doses of APL-130277 (10mg and 15mg) compared to subcutaneous apomorphine in healthy volunteers (2mg and 3mg).
- Sublingually administered APL-130277 reached known therapeutic apomorphine plasma levels comparable to subcutaneous apomorphine with a longer duration over the minimum efficacious plasma concentration.
- APL-130277 demonstrated a more rounded peak, lower maximal concentration and less steep rise to maximal concentration compared to subcutaneous apomorphine, leading to less dopaminergic AEs. This was evident as a higher incidence of nausea and vomiting was reported when subjects were given the subcutaneous apomorphine versus APL-130277.
- APL-130277 was demonstrated to be safe and well-tolerated and no subjects discontinued treatment with APL-130277 due to an AE.
About Cynapsus
Cynapsus is a specialty central nervous system pharmaceutical company developing and preparing to commercialize a Phase 3, fast-acting, easy-to-use, sublingual thin film for the on-demand turning ON of debilitating OFF episodes associated with Parkinson’s disease (PD).
Forward-Looking Statements
This announcement contains “forward-looking statements” within the meaning of applicable securities laws. 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, in include, but are not limited to those factors identified under the caption “Risk Factors” in the Company’s filings and reports in the United States with the United States Securities and Exchange Commission (the “SEC”) available on the SEC’s web site, 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.
Cynapsus Therapeutics
Anthony Giovinazzo
President and CEO
(416) 703-2449 x225
ajg@cynapsus.ca
Cynapsus Therapeutics
Andrew Williams
COO & CFO
(416) 703-2449 x253
awilliams@cynapsus.ca
Russo Partners LLC
Matt Middleman
(212) 845-4272
matt.middleman@russopartnersllc.com
TraderPower Featured Companies
Top Small Cap Market News
- $SOBR InvestorNewsBreaks – SOBR Safe Inc. (NASDAQ: SOBR) Closes on $8.2M Private Placement
- $CLNN InvestorNewsBreaks – Clene Inc. (NASDAQ: CLNN) Announces Participation at Two Upcoming Investor Conferences
- $ATBHF Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Releases Updated Report on Storm Copper Project Drilling Program
- $LGVN InvestorNewsBreaks – Longeveron Inc. (NASDAQ: LGVN) to Present at This Month’s Congenital Heart Surgeons’ Society Annual Meeting
- $LEXX InvestorNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Begins Subject Dosing in Human Pilot Study #3 Evaluating Oral DehydraTECH-Processed Tirzepatide
- $FSTTF InvestorNewsBreaks – First Tellurium Corp. (CSE: FTEL) (OTC: FSTTF) Shares Additional Information on the PyroDelta Thermoelectric Generator, Relationship with Subsidiary
- $TMET.V Gold Stutters as Strong US Jobs Data Dampens Expectations of Large Rate Cuts
- $RFLXF JPMorgan Executive Says US Backlash Against ESG Is Exaggerated
- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp. (d/b/a MedCana) (SFWJ) Releases Report on Series of Acquisitions, Multiple Cannabis Licenses
- $EAWD IEA Hosts G20 Ministers, Influential Personalities to Discuss Clean and Affordable Energy Transition
Recent Posts
- $EAWD IEA Hosts G20 Ministers, Influential Personalities to Discuss Clean and Affordable Energy Transition
- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp. (d/b/a MedCana) (SFWJ) Releases Report on Series of Acquisitions, Multiple Cannabis Licenses
- $RFLXF JPMorgan Executive Says US Backlash Against ESG Is Exaggerated
- $TMET.V Gold Stutters as Strong US Jobs Data Dampens Expectations of Large Rate Cuts
- $FSTTF InvestorNewsBreaks – First Tellurium Corp. (CSE: FTEL) (OTC: FSTTF) Shares Additional Information on the PyroDelta Thermoelectric Generator, Relationship with Subsidiary
- $LEXX InvestorNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Begins Subject Dosing in Human Pilot Study #3 Evaluating Oral DehydraTECH-Processed Tirzepatide
- $LGVN InvestorNewsBreaks – Longeveron Inc. (NASDAQ: LGVN) to Present at This Month’s Congenital Heart Surgeons’ Society Annual Meeting
- $ATBHF Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Releases Updated Report on Storm Copper Project Drilling Program
Recent Comments
Archives
- October 2024
- January 2023
- June 2022
- December 2021
- September 2021
- August 2021
- July 2021
- June 2021
- May 2021
- April 2021
- March 2021
- February 2021
- January 2021
- December 2020
- November 2020
- October 2020
- September 2020
- August 2020
- July 2020
- June 2020
- May 2020
- April 2020
- March 2020
- February 2020
- January 2020
- December 2019
- November 2019
- October 2019
- September 2019
- August 2019
- July 2019
- June 2019
- May 2019
- April 2019
- March 2019
- February 2019
- January 2019
- December 2018
- November 2018
- October 2018
- September 2018
- August 2018
- July 2018
- June 2018
- May 2018
- April 2018
- March 2018
- February 2018
- January 2018
- December 2017
- November 2017
- October 2017
- September 2017
- August 2017
- July 2017
- June 2017
- May 2017
- April 2017
- March 2017
- February 2017
- January 2017
- December 2016
- November 2016
- October 2016
- September 2016
- August 2016
- July 2016
- June 2016
- May 2016
- April 2016
- March 2016
- February 2016
- January 2016
- December 2015
- November 2015
- October 2015
- September 2015
- August 2015
- July 2015
- June 2015
- May 2015
- April 2015
- March 2015
- February 2015
- January 2015
- December 2014
- November 2014
- October 2014
- September 2014
- August 2014
- July 2014
- June 2014
- May 2014
- April 2014
- March 2014
- February 2014
- January 2014
- December 2013
- November 2013
- October 2013
- September 2013
- August 2013
- July 2013
- June 2013
- May 2013
- April 2013
- March 2013
- February 2013
- January 2013
- December 2012
- November 2012
- October 2012
- September 2012
- August 2012
- July 2012
- June 2012
- May 2012
- April 2012
- March 2012
- February 2012
- January 2012
- December 2011
- November 2011
- October 2011
- September 2011
- August 2011
- July 2011
- June 2011
- May 2011
- April 2011
- March 2011
- February 2011
- January 2011
- December 2010
- November 2010
- October 2010
- September 2010
- August 2010
- July 2010
- June 2010
- May 2010
- April 2010
- March 2010
- February 2010
- January 2010
- December 2009
- November 2009
- October 2009
- September 2009
- August 2009
- July 2009
- June 2009