Cynapsus Therapeutics Inc. (CYNA)

[someconcerns]

Fierce Drug Delivery article about Ph 3 for CYNA

http://www.fiercedrugdelivery.com/story/cynapsus-sublingual-parkinsons-med-levodopa-nonresponders-progresses-phiii/2015-06-30?utm_medium=nl&utm_source=internal

Cynapsus ($CYNA) kicked off patient enrollment in its Phase III clinical trial of sublingual apomorphine for Parkinson's patients who stop responding to levodopa.

The second-line medication is currently available as a subcutaneous injectable, dubbed Apokyn. But the medication is plagued by practical delivery issues, such as the need for a skilled nurse to carry out its 15-step administration process, perform titration and contend with injection-site reactions. Note that Parkinson's patients in the "off" state suffer from severely limited mobility, adding to the complications and making self-administration of the injectable impossible.

But Cynapsus' under-the-tongue formulation is simpler to use and can be self-administered, meaning if approved, it should improve upon Apokyn's market penetration rate of about 5% of the potential market. Zacks Small Cap Research predicts it will be used in one-fourth of severe Parkinson's patients with off issues by 2024, assuming approval.

To that end, the company announced its first patient in the sublingual candidate's pivotal Phase III trial, which will eventually enroll about 126 Parkinson's patients who have at least one off episode a day, with total off time of least two hours per day. The primary endpoint will be mean change in MDS-UPDRS Part III score 30 minutes after dosing at week 12.

The secondary endpoint will be the percentage of patients who convert from the off to the on state at or before 30 minutes of dosing, also at week 12.

Phase III commences after promising Phase I and II data was presented at the 19th International Congress of Parkinson's Disease and Movement Disorder in San Diego.