Intec Pharma's Data from Pharmacokinetic Study of AP-CD/LD 50/500 mg Dosed Three Times Daily Accepted for Presentation at the XXIV World Congress on Parkinson's Disease and Related Disorders

PR Newswire - finance.yahoo.com Posted 7 months ago

JERUSALEM, May 2, 2019 /PRNewswire/ -- Intec Pharma Ltd. (NTEC) ("Intec" or "the Company") today announces that the results from a pharmacokinetics (PK) study of the Accordion Pillâ„¢-Carbidopa/Levodopa (AP-CD/LD) 50/500 mg dosed three times per day (TID) was accepted for presentation in a poster at the upcoming XXIV World Congress on Parkinson's Disease and Related Disorders taking place June 16-19, 2019 at the Lyon Convention Centre in Montreal, Canada. 

The presentation will highlight data collected during a PK study conducted in Parkinson's disease (PD) patients, which demonstrated that AP-CD/LD 50/500 dosed three times per day met the study primary endpoint of reducing plasma levodopa variability compared to standard oral CD/LD dosed five times per day (p=0.0048).

The data will be presented as follows:

Title:                Pharmacokinetics of multiple doses of Accordion Pill Carbidopa/Levodopa in patients with Parkinson's disease 

Poster#:           067

Date:               June 18, 2019 from 12:15 pm to 1:15 pm (Eastern time)

Presenter:       C. Warren Olanow, M.D., Professor and Chair Emeritus, Department of Neurology at Mount Sinai School of Medicine, New York

"We are delighted to have these positive PK data presented by Dr. Olanow, a world-leading Parkinson's disease expert, at this prestigious medical meeting. These PK results are important as they confirm our expectations that AP-CD/LD 50/500 TID reduces levodopa variability in PD patients, which we expect will translate to a reduction in motor fluctuations in these patients," noted Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma. "With the recent announcement of the last patient's last visit in our pivotal Phase 3 study of AP-CD/LD in advanced PD patients, we are looking forward to reporting topline efficacy results this summer."

About Intec Pharma Ltd.

Intec Pharma 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 includes two product candidates in clinical trial stages: Accordion Pill Carbidopa/Levodopa, or AP-CD/LD, which is in late-stage Phase 3 development for the treatment of Parkinson's disease symptoms in advanced Parkinson's disease patients, and AP-cannabinoids, an Accordion Pill to deliver either or both of the primary cannabinoids contained in Cannabis sativa, cannabidiol (CBD) and tetrahydrocannabinol (THC) for various pain indications. In addition, the Company has a feasibility agreement for the development of a custom-designed Accordion Pill for a proprietary compound with Novartis Pharmaceuticals. 

For more information, visit www.intecpharma.com. Intec Pharma routinely posts information that may be important to investors in the Investor Relations section of its website.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward looking statements about our expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: our limited operating history and history of operating losses, our ability to continue as a going concern, our ability to obtain additional financing, our ability to successfully operate our business or execute our business plan, the timing and cost of our clinical trials, the completion and receiving favorable results in our clinical trials, our ability to obtain and maintain regulatory approval of our product candidates, our ability to protect and maintain our intellectual property and licensing arrangements, our ability to develop, manufacture and commercialize our product candidates, the risk of product liability claims, the availability of reimbursement, and the influence of extensive and costly government regulation. More detailed information about the risks and uncertainties affecting us is contained under the heading "Risk Factors" included in our most recent Annual Report on Form 10-K filed with the SEC on February 27, 2019, and in other filings that we have made and may make with the Securities and Exchange Commission in the future.

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Intec Pharma Investor Contact:

Anne Marie Fields      
VP-Corporate Communications & Investor Relations      
646-200-8808                 
[email protected]           

 

         

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