New Zealand natural pharmaceutical company Vital Food Processors Ltd announced the completion of patient enrolment for its IDEA Trial, a Phase 3 trial investigating the role of the company’s kiwifruit extract Zyactinase in alleviating the symptoms associated with Constipation-predominant Irritable Bowel Syndrome (IBS-C).
The 13-centre trial investigates the efficacy of Vital Foods’ proprietary and patented kiwifruit extract Zyactinase, marketed under the brand names Phloe® and Kivia®, in trial participants diagnosed with irritable bowel syndrome (IBS) with constipation.
The randomised, placebo-controlled, double-blinded Phase 3 clinical trial has recruited over 180 subjects who are treated over a three-month period. Recruitment has taken place at 13 sites across Australia and New Zealand.
The IDEA Trial is designed to build on the extensive platform of existing clinical and nonclinical research supporting the efficacy and safety of Zyactinase. Vital Foods’ chief executive Justus Homburg said: “This trial is designed to build on the results of previous studies that focussed on relief of constipation and showed that Kivia relieves abdominal bloating and pain in people with the symptoms generally associated with IBS.” IDEA Trial Principal Investigator Professor Peter Gibson of Melbourne’s Monash University and the Alfred Hospital, commented: “Kivia is an appealing therapy and it is very well tolerated and seems to have prolonged benefit. These observations need to be scientifically tested and that is what the IDEA Trial is designed to do.” University of Adelaide’s Professor Jane Andrews, the investigator managing the trial at the Royal Adelaide Hospital, added: “There’s such a lot of advertising of health claims for foods and supplements, it’s really refreshing to find a company prepared to put their product to the test in a properly designed clinical trial”.
Detailed final results of the IDEA trial are expected before the end of the year.
Irritable Bowel Syndrome is a chronic gastrointestinal disorder estimated to affect between 1 in 10 and almost 1 in 4 people globally. Although it affects approximately 15% of population, the International Federation for Functional Gastrointestinal Disorders reports that most IBS sufferers do not seek medical help. Nevertheless, in the United States between 2.4 and 3.5 million annual physician visits are for patients diagnosed with IBS, and it has become a major women’s health issue with two out of three people with IBS being women.
Zyactinase is reputed to be one of the most effective, gentle laxative therapies currently available. Zyactinase is a 100% natural product derived from New Zealand kiwifruit using Vital Foods’ proprietary processing technology with no artificial ingredients. Products formulated with Zyactinase, including Phloe and Kivia capsules and chewable tablets. Seven separate clinical studies have confirmed that Zyactinase formulations improve general digestive health, normalise bowel function, reduce bloating, minimise episodes of occasional constipation, and assist in reducing abdominal pain and discomfort. Zyactinase formulations have none of the side effects commonly associated with harsher laxatives.
The IDEA Trial is a Randomised, Double-blinded, Placebo-controlled Study of Kivia 575mg Zyactinase Capsule for the Improvement of Digestive Health Parameters in Subjects with Irritable Bowel Syndrome with Constipation Symptoms. The primary endpoint is determined by the overall responder rate for both increased weekly stool frequency of at least one complete spontaneous bowel movement (CSBM) AND decreased weekly average of worst abdominal pain of at least 30% from baseline using a Visual Analogue Scale (VAS) of 0-10 cm. This primary endpoint is consistent with the Food & Drug Administration (FDA) and the European Medicines Agency guidance on the design of IBS-C clinical trials. The new clinical study is a key step towards confirming Kivia as a treatment of a clinically diagnosed disease internationally, and in turn, growing opportunities in the global consumer healthcare market.
Vital Foods’ was established to provide the digestive health benefits of kiwifruit through easy to consume digestive health products for all ages. The company’s first product on the market was Kiwi CrushTM, a frozen kiwifruit drink that is made available to most patients in hospitals and nursing home in New Zealand and is sold as a digestive aid in supermarkets in New Zealand.
Research into its therapeutic effects led to the development of Phloe, also based on kiwifruit, which was launched in 2007 and is now available in pharmacy, health food and grocery outlets in New Zealand and is available globally through www.digestivephloe.com. Together, the two products currently make up the highest-selling digestive health product family sold in New Zealand.
Vital Foods was formed by two dedicated kiwifruit industry experts and launched by a group of committed local New Zealand investors. Since 2006, Vital Foods’ Research & Development efforts have been financed through a sophisticated syndicate that is predominantly comprised of Inventages Venture Capital and BioPacific Ventures.
For further information, contact Justus Homburg, Vital Food Processors Ltd, +61 7 3103 2622.