Intec Pharma Completed a Phase I Clinical Trial With Its Third Pipeline Product
JERUSALEM, ISRAEL--(Marketwired - Mar 10, 2016) - 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 completed a Phase I clinical trial with its third pipeline product.
The product is being developed for the prevention and treatment of gastroduodenal and small bowel Nonsteroidal Anti-Inflammatory Drug (NSAID) induced ulcers, and it is based on a new Accordion Pill formulation with an existing drug.
The Pharmacokinetics (PK) results demonstrated in this Phase I trial were within the well-defined safety levels of the drug, which enable the Company to proceed with further development of the Accordion Pill with the existing drug.
Many drugs, such as proton pump inhibitors, are currently used to protect the stomach and duodenum from NSAID induced injuries, such as ulcers. Technological improvements in the detection of the small intestine have shown that injuries associated with NSAID usage also occur frequently in the small intestine. Currently, there are no proven-effective therapies for these NSAID induced injuries in the small intestine.
NSAIDs are widely used to manage the pain of osteoarthritis, rheumatoid arthritis and other painful conditions. The most common type of arthritis is called osteoarthritis, which is one of the most frequent causes of physical disability among adults. It is estimated that by 2030, 20% of Americans who are over 65 years old, or approximately 70 million people, will be at risk for osteoarthritis. The second most common form of arthritis is rheumatoid arthritis. It is estimated that by 2023, approximately 2 million Americans over 18 years old will be diagnosed with rheumatoid arthritis.
The Phase I clinical trial was a three arm, crossover, single dose PK study, in 18 healthy volunteers. The trial compared the plasma levels of the drug when given with two different doses of the Accordion Pill with those of the current formulation of the existing drug.
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, which 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, which is being developed for the indication of treatment of insomnia, including sleep induction and the improvement of sleep maintenance, and an Accordion Pill that is being developed for the prevention and treatment of gastroduodenal and small bowel Nonsteroidal Anti-Inflammatory Drug induced ulcers.
Forward Looking Statements
This press release contains forward-looking statements about the Company's 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 involve certain risks and uncertainties, including, among others, risks impacting the ability of the Company to complete any public offering of its securities because of general market conditions or other factors and risks that could cause the Company's results to differ materially from those expected by Company management. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. 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 the company undertakes 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 the company's control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in the company's filings with the Securities and Exchange Commission, and include the following: the company's ability to develop and commercialize its product candidates and obtain additional financing necessary therefor; the length, cost and uncertain results of the company's clinical trials; the potential of adverse side effects or other safety risks that could preclude the approval of the company's hormone therapy drug candidates; the availability of reimbursement from government authorities and health insurance companies for the company's products; the impact of product liability lawsuits; and the influence of extensive and costly government regulation.
Chief Executive Officer
(+972) (2) 586-4657
Phone (+1) 212 554-5482
Phone (+1) 646 863-8998
Source: Marketwired (Canada) (March 10, 2016 - 8:00 AM EST)