Cynapsus Therapeutics (CYNA) Announces Publication of APL-130277 CTH-105 Phase 2 Data

August 12, 2016 6:14 AM EDT
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Cynapsus Therapeutics Inc. (Nasdaq: CYNA) announced that data from its CTH-105 Phase 2 trial of APL-130277 for the treatment of OFF episodes in patients with Parkinson’s disease was published in the peer-reviewed journal Movement Disorders. The paper, titled “Sublingual Apomorphine (APL-130277) for the Acute Conversion of OFF to ON in Parkinson’s Disease” by Robert A. Hauser, M.D., et al., was published electronically ahead of print. The company had previously announced top-line data from the CTH-105 trial in November of 2014.

Key findings from the manuscript include:

  • A full ON response was achieved by 15 of 19 patients dosed (78.9%) with a mean dose of 18.4 mg
  • All 15 responders (100.0%) achieved a full ON response within 30 minutes from the time of administration, and 6 of 15 (40.0%) achieved a full ON response within 15 minutes of administration
  • The mean duration of ON time was 50 (SD 19.4) minutes with 9 of 15 (60.0%) patients remaining fully ON for 90 minutes
  • A significant improvement in Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS) from baseline was observed at all time points with a mean maximum change of 18.9 points
  • APL-130277 was safe and generally well-tolerated with no discontinuations because of adverse events

CTH-105 was a Phase 2 multicenter, open-label, clinical trial assessing APL-130277 in patients with Parkinson’s disease who experience OFF episodes, with a total duration of OFF of at least two hours daily. OFF episodes were achieved by having patients take their last dose of levodopa the night before coming into the clinic. Patients were not allowed to take their first dose of levodopa or other PD medications in the morning, resulting in a morning OFF state. Patients were then given escalating doses of APL-130277 (at a minimum of three hours between doses) until ON was achieved, as documented by study staff, the patient and a clinician assessment of MDS-UPDRS. The MDS-UPDRS score was measured at 15, 30, 45, 60 and 90 minutes.

Albert Agro, Ph.D., author and chief medical officer of Cynapsus, said “The Phase 2 results published in this manuscript confirm the preliminary findings announced in 2014 that APL-130277 was highly effective at rapidly and safely converting patients from OFF to full ON. We look forward to continued validation of our approach to treating patients suffering with OFF episodes with top-line data from our Phase 3 efficacy study expected late in the third quarter or early fourth quarter of this year. We also intend to share longer-term safety data and file our new drug application in the first half of 2017.”

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