Study will evaluate safety and efficacy of Shylicine®, the first-ever investigational treatment developed for microvillus inclusion disease

HAMDEN, Conn., June 4, 2019 /PRNewswire/ — Vanessa Research, Inc. (VRI) — a biomedical company founded on the desire to “give hope where none existed” by making an impact on healthcare markets that are often overlooked — has been granted regulatory approval by the Turkish Ministry of Health to conduct a Phase II Clinical Trial for Shylicine®, an investigational oral solution developed to treat the rare and lethal microvillus inclusion disease.

About the Disease

Microvillus inclusion disease (MVID) is an exceedingly rare genetic gastrointestinal disorder that afflicts infants with diarrhea so severe that malnutrition and dehydration are inevitable, and often lethal, if the condition is not appropriately treated.

The current standard of care for MVID is total parenteral nutrition, in which fluids and nutrients are delivered intravenously for up to 24 hours each day. This can often result in infection, damage to the veins, and liver failure. Patients may ultimately seek a small bowel and/or liver transplantation; a process which comes with many challenges and complications of its own.

Vice President of Research and Development, Dmitry Kravtsov, M.D. identified the role that intestinal cell immaturity plays in the severity of diarrhea while working as a research scientist at the Yale School of Medicine. His work suggested that the failure of the MVID intestine may not be permanent, and that the immature cells of the gut could be restored with appropriate intervention – allowing a patient’s intestine to absorb necessary hydration and nutrition. These findings have the potential for broader applications in the field of secretory diarrhea: currently, Vanessa Research is in the preclinical development stage for Hunazine®, a treatment designed to neutralize the cholera toxin in affected patients.

About the Trial

Shylicine® is intended to serve as an oral treatment that could potentially eliminate patients’ dependence on total parenteral nutrition. The twelve-week Shylicine® trial will assess the safety and efficacy of the investigational treatment. The primary endpoint is reduction in the volume of diarrhea and frequency of stool, as well as a decrease in the duration of feeding via total parenteral nutrition.

In addition to receipt of approval to begin the trial, Vanessa Research has been granted a drug import permit, which will allow the U.S.-based company to deliver Shylicine® to the trial site, the Ankara University School of Medicine.

“Authorization by the Turkish Ministry of Health and the support of the Ankara University School of Medicine are critical, given that a relatively high volume of reported MVID cases are located in the country,” explains Norman Gray, CEO of Vanessa Research. “This is a critical step towards addressing the unmet needs of this rare disease community.”

About Vanessa Research

Vanessa Research, Inc. (VRI) is a biomedical company founded on the desire to “give hope where none existed” by making an impact on healthcare markets that are often overlooked. VRI’s continually-expanding pipeline of innovative medicine, medical devices, and consumer and public health products reflects the company’s inventive nature and commitment to delivering solutions that increase access to quality care. The company’s flagship products, Shylicine® and Hunazine® are the first-ever drug developed to treat the rare, lethal microvillus inclusion disease and a treatment designed to neutralize the cholera toxin, respectively.

VRI is based in Hamden, Connecticut, with offices in Farmington, Connecticut; London, England; Budapest, Hungary; and Navarre, Spain.