Intec Pharma Ltd. Receives An IRB Approval To Initiate Phase III Clinical Trial Of AP - CDLD For The Treatment Of Parkinson's Disease
JERUSALEM, ISRAEL--(Marketwired - December 14, 2015) - Intec Pharma Ltd. (NASDAQ: NTEC) (TASE: INTP), a clinical-stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology, today announced that it has received a US centralized institutional review board (IRB) approval to initiate its Phase III clinical trial for its lead product, the Accordion Pill Carbidopa/Levodopa, or AP-CDLD, for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients.
Approximately 460 patients will be enrolled in this single pivotal Phase III study in advanced Parkinson's disease patients. The total treatment period for each patient will be 25 weeks. The primary efficacy endpoint will be a change from baseline to termination of treatment in the percent of daily off time during waking hours.
Zeev Weiss, CEO of Intec Pharma, said: "Levodopa is the most effective and widely used treatment for Parkinson's disease symptoms. However, reports indicate that up to 50% of patients show onset of motor fluctuations within two years of starting conventional Levodopa therapy. Various approaches are attempting to address this issue. We are very excited to receive IRB approval and to be entering into our Phase III clinical trial for our lead product candidate, AP-CDLD."
About Intec Pharma Ltd.
Intec Pharma Ltd. is a clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology. The Company's Accordion Pill is an oral drug delivery system that is designed to improve the efficacy and safety of existing drugs and drugs in development by utilizing an efficient gastric retention and specific release mechanism. The Company's product pipeline currently includes three product candidates in clinical trial stages: Accordion Pill Carbidopa/Levodopa, or AP-CDLD, is being developed for the indication of treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients Accordion Pill Zaleplon, or AP-ZP, for the indication of the treatment of insomnia, including sleep induction and the improvement of sleep maintenance, is our second pipeline product. We are also developing a third Accordion Pill for the treatment of gastoduodenal and small bowel Nonsteroidal Anti-Inflammatory Drug induced ulcers.
Forward Looking Statements
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