Its annoucement about VITA-100 comes as U.S. regulators have been approving cannabis-based products for various disorders.
VITA-100 delivers two of the active ingredients in cannabis plants to the intestinal tract to alleviate inflammation there. Those components are cannabidiol and tetrahydrocannabinol, or THC.
Vitality calls the new class of treatments it is developing for gut disorders cannabinoid prodrugs. The body converts them into a form that helps them do a better job of targeting specific organs or tissue, the company said.
The U.S. Food and Drug Administration has approved Abbvie’s formulation of THC sold under the name Dronabinol to stimulate appetite and reduce nausea and vomiting. The medication acts on the central nervous system.
Since VITA-100’s action is limited to the gut, it does not cause psychotropic problems in the brain.
Preclinical-trial studies in animal models of bowel disease have shown that cannabis-based therapies can reduce colon damage and prevent weight loss, Vitaly said. The result was a significant improvement in gastrointestinal health, compared with animals taking a placebo.
Researchers also achieved good results when they used cannabis-based therapies to treat mice with a specific bowel disease — ulcerative colitis.
Previous studies have also suggested that THC can put another bowel disease — Crohn’s — into remission.
And many bowel disease patients treated with THC report less abdominal pain, Vitaly said.
Vitality plans to start clinical trials of VITA-100 as a potential treatment for bowel diseases, irritable bowel syndrome, and narcotic bowel syndrome in the first half of 2018. The hallmark of narcotic bowel syndrome is chronic or frequently recurring abdominal pain that increases with the use of opioids.
“As independent clinical studies are demonstrating the therapeutic effects of THC, we are well positioned with our VITA-100 gut-restricted prodrug formulation,” Robert Brooke, Vitaly’s chief executive oficer, said in a press release.
“Many parents, pediatric gastroenterologists, and affected adults are eagerly seeking a treatment option that provides therapeutic effects without the resulting psychoactivity,” he said. “In developing a THC prodrug, we will also benefit from a robust track record of safety and history of FDA drug approvals.”