Drug development start-up Intec Pharma Ltd. (Israel) announced today the successful results of a clinical trial using a drug marker on healthy volunteers at the Sheba Medical Center in Israel.
The results validate the company's proprietary Accordion Pill, a novel gastroretentive platform that targets drugs that must be absorbed by the body in what is known as the narrow absorption window, the intestine segment below the stomach.
The study used riboflavin (vitamin B2) as a model active ingredient to demonstrate the unique capability of the Accordion Pill formulation to prolong absorption of pharmaceuticals into the blood. The prolonged absorption enables greater bioavailability while reducing dosage and side effects. Many important pharmaceutical compounds are limited in their therapeutic action because insufficient amounts are absorbed into the body through this area,
"The study results confirm Accordion Pill as the first gastroretentive formulation to maintain controlled release and absorption of a drug for more than 6 hours following a low calorie meal," said Intec Pharma CEO Efi Cohen-Arazi. "This is a major milestone, positioning Intec Pharma as a leader in the gastric retention field with a platform technology that can improve the bioavailability of drugs in an estimated $50 billion market," he added.
The study was based on cross-over data from 13 healthy volunteers who received alternate 75 mg. doses of Accordion Pill riboflavin and regular immediate release riboflavin following a low calorie meal (280 calories).
The study results showed that the riboflavin Accordion Pill was retained in the stomach and continued to release riboflavin to its absorption sites for significantly longer periods of time than regular riboflavin. The stomach retention time for Accordion Pill riboflavin was more than six hours compared to less than two hours with regular riboflavin; the absorption time for Accordion Pill riboflavin was eight hours compared to three hours for regular riboflavin. As a result, the total amount of riboflavin absorbed by the body was 100% greater when the Accordion Pill was used than when it was not.
The study results were presented by Prof. Amnon Hoffman of the Hebrew University at the 32nd annual meeting of the Controlled Release Society in Miami, Florida. Hoffman, together with Prof. Michael Friedman, is co-developer of the Accordion Pill and a member of the Intec Pharma Scientific Advisory Board.
Published by Globes [online], Israel business news - www.globes.co.il - on Tuesday, June 21, 2005