Further to the Company’s reports as of October 29, 2013 and October 28, 2014 (references number: 2013-01-177123 and 2014-01-182289, respectively), which are presented hereof by reference, the Company is pleased to report that on May 5, 2015, a meeting was held with the U.S. Food and Drug Administration (“FDA”), in which the clinical development program of the Accordion Pill Carbidopa Levodopa (“AP-CDLD”), for the treatment of advanced stages Parkinson’s Disease patients, was concluded.
Based on this, the main principles of the single required pivotal Phase III Clinical Trial in advanced Parkinson’s disease(“PD”) patients, conducted under Section 505(b)(2) of the Food, Drug and Cosmetic Act, will be:
- A multicenter, randomized, double-blind, double-dummy, parallel, active-controlled study, comparing the efficacy and safety of AP-CDLD to Sinemet IR, an immediate release CDLD, which is a conventional Levodopa medication for the treatment of PD patients
- Approximately 460 PD patients will be enrolled into the study
- Total treatment period for each patient will be 25 weeks, composed of:
- 6 weeks open-label titration on Sinemet IR (all patients)
- 6 weeks open-label titration on two AP-CDLD strengths, given BID or TID (all patients)
- 13 weeks double-blind, double-dummy active comparator period, in which half of the patients will be randomized to AP-CDLD and half to Sinemet IR
- Primary efficacy endpoint: Change from baseline to termination of treatment in the percent of daily off time during waking hours based on Hauser home diaries.
The Company’s management considers the agreement on the outline of the Phase III clinical study, as aforesaid, with the FDA, an important milestone with respect to the Company’s leading product. The Company estimates the total costs of this clinical study to be approx. US $30 million.
The information regarding the anticipated operations of the Company included in this immediate report are forward-looking statements, as defined in the Securities Law – 1968, based on information currently available to the Company. These estimates may not materialize, in whole or in part, or may materialize differently than estimated, due to various factors, such as factors beyond the Company’s control, including risk factors related to the Company’s operations as specified in Section 1.30 of the Periodic Report.