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16 Jan 2014

High Hopes for Cynapsus's Sublingual Strip for Controlling Severe Parkinson's Disease

Cynapsus Therapeutics Inc, a specialty pharmaceutical company, today announced positive top line data from its recently completed healthy volunteer pilot crossover trial comparing APL-130277, a sublingual thin film strip formulation of apomorphine, to a commercially available injectable formulation of apomorphine.


The study results further support the advancement of APL-130277 for management of “OFF” episodes in Parkinson’s disease through the section 505(b)(2) regulations of the United States Food and Drug Administration Act, which provides an accelerated path to approval for new formulations of approved medicines.


Mr Anthony Giovinazzo, President and CEO of Cynapsus commented: “Results from this CTH103 clinical study are an important de-risking event for our product and set the stage for completing in the next 2 years the clinical requirements for qualifying APL-130277 for a 505(b)(2) New Drug Application. Importantly, the data indicate that APL-130277 may have advantages over an injectable product (i.e., apomorphine hydrochloride subcutaneous injection, Apokyn® or Apo-Go®) by reducing the frequency and intensity of side effects including nausea and vomiting versus those commonly reported for a subcutaneous injectable formulation. The results also suggest that APL-130277 exhibits comparable time to maximal concentrations in the blood and therapeutic plasma levels that are similar or longer than those seen following subcutaneous injection.”


Mr Giovinazzo added: “Assuming concurrence with the regulatory authorities, we expect that results of this study will enable us to proceed directly to the completion of two small efficacy studies and a safety study, in patients with Parkinson’s disease. Our plan is to design a clinical registration program for APL-130277 that demonstrates efficacy as measured by both time to “ON” and duration of “ON” in patients with Parkinson’s disease, with possible advantageous adverse event claims. If substantiated in the registration clinical trials, the findings from the CTH103 healthy volunteer study indicate that the sublingual formulation of APL-130277 could have measurable advantages for patients and their caregivers over a subcutaneous injection of apomorphine.”


Dr Albert Agro, Chief Medical Officer at Cynapsus, also commented: “We are indebted to The Michael J. Fox Foundation for Parkinson’s Research for supporting this important milestone for APL-130277. Their support was fundamental to the success of this study. We are very pleased with the results, which confirm that our sublingual thin film strip formulation is effective at delivering apomorphine with the potential to reach efficacious plasma levels, but with what appears to be a reduced side effect profile compared to the subcutaneous injectable formulation. We look forward to initiating the efficacy program in patients suffering from Parkinson’s disease with debilitating motor complications.”

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