Vanessa Research, Inc. Receives EU Patent For Shylicine, A Therapy For A Rare Pediatric Disorder

Published: Jul 14, 2017

June 30, 2017
Hamden, Connecticut – Vanessa Research, Inc. (VRI), an emerging healthcare and biotech company, announced today that the European Patent Office (EPO) has issued a patent for the formulation of an oral anti-diarrheal treatment for babies and young children with Microvillus Inclusion Disease (MVID). The U.S. and world patents are pending.

The formula, Shylicine™, has been developed at the company’s Hamden facility over the past two years, and is now being prepared for investigational production in Hungary.

Dmitry Kravtsov, MD, VP of Research and Development, and co-patent holder, said: “The resulting patent has added a valuable asset to VRI’s portfolio.” Dr. Kravtsov believes that this milestone and the success of the formula is a breakthrough to the MVID community at-large.

MVID is a rare, genetic disease that causes chronic diarrhea in newborn babies; undiagnosed, the disease is lethal, and death occurs rapidly. To survive, most MVID patients depend on intravenous fluid, known as Total Parenteral Nutrition (TPN), and ultimately liver and bowel transplantation.

The disorder is due to a mutation in the myosin VB (MYO5B) gene that limits the growth and function of the epithelial cells in the intestine; these immature cells cannot absorb fluids, nutrients or electrolytes.
Shylicine™ is a unique fixed-dose combination formulated to address all critical elements of the disease at once. It is believed that Shylicine™ induces immature cells in the intestinal mucosa to mature, with the goal for those afflicted with MVID to be able to eat and drink normally.

According to Henry J. Binder, MD, Professor Emeritus and Senior Research Scientist in Digestive Diseases at the Yale School of Medicine,
“You cannot overstate the significance of a therapy for MVID that is taken orally, and that restores the intestine such that absorption and secretion are in normal balance. The goal is to eliminate the need for TPN in these patients.”

VRI will soon begin clinical trials of Shylicine™, which is currently limited to investigational use only and is not available for sale.

About Vanessa Research
Vanessa Research is based in Hamden, Connecticut, with offices in London, England and Budapest, Hungary. VRI was founded on the desire to build a 21st century, sustainable, innovative, entrepreneurial organization by bringing together a collection of diverse scientists, engineers, business professionals and academics to create solutions in medicine.

The company has etched its niche in developing innovative products by commercializing complex ideas with simple solutions. This is done by creating a respectful teamwork environment conducive to open, unrestrained dialogue and invention.

The company’s mission is to “give hope where none existed”™ by delivering healthcare products that improve and increase access to quality care while decreasing costs.

Disclosure Notice
The information contained in this release is as of 30 June, 2017. VRI assumes no obligation to update forward-looking statements contained in this release as the result of new information, future events or developments.

This release contains forward-looking information about Shylicine™, including a potential indication for the treatment of Microvillus Inclusion Disease and their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including, without limitation, the ability to meet anticipated clinical trial commencement, completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results; whether and when any new drug applications may be filed in any jurisdictions for Shylicine™ ; whether and when regulatory authorities in any such jurisdictions where applications for Shylicine™ may be filed may approve any such applications, which will depend on the assessment by such regulatory authority of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of Shylicine™ ; and competitive developments.

For more information, please visit www.vanessaresearch.com

Company contact:
Benjamin P. Szabo, J.D.
Company Secretary
Vanessa Research, Inc.
925 Sherman Avenue,
Hamden, CT, 06514
U.S.A.
benjamin.szabo@vanessaresearch.com

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