Under the agreement, Cook will direct the development of Regentys’ ECMH Rectal Solution, or extracellular matrix hydrogel, which Regentys plans to start clinical trials on in 2018. Cook will also manufacture the therapy.
“We have been working with the outstanding team at Cook Biotech for the last several months to complete the technology transfer of our product in order to scale our manufacturing for our clinical program, which will begin in the second half of 2018,” Brian Andersen, Regentys’s chief business officer, said in a press release.
ECMH is a non-drug, non-surgical treatment for ulcerative colitis. It is based on extracellular matrix, or ECM, the non-cell component in all tissue and organs that provides the physical structure for the cell constituents. It is fundamental for the normal functioning and stability of tissue development.
“This is a unique application of ECM that will help treat a very debilitating disease,” said Umesh Patel, the president of Cook Biotech. “We’re looking forward to working with the team at Regentys to bring this product to market.”
Hallmarks of ulcerative colitis include chronic diarrhea, pain, bleeding, urgency to defecate and increased risk of cancer. The disease causes inflammation and sores in the lining of the large intestine. It usually affects the lower section of the colon and rectum, but can affect the entire colon.
ECMH is a pig-derived product administered through the rectum. The powder is mixed with a saline solution and delivered as a liquid. When the medicine reaches body temperature, it gels, coating the gastrointestinal tract’s mucus lining. The gel provides a barrier to help the body rebuild the damaged tissue.
In preclinical-trial studies, ECMH restored cell barrier function, promoted rapid regeneration of tissue, reduced colitis symptoms, and reversed inflammation and sores.
The findings suggested that ECMH can help the colon heal and prevent colitis from occurring again. To test this hypothesis, Regentys plans clinical trials in 2018, beginning with a pilot study in patients with mild to moderate ulcerative colitis. Future applications could include the bowel disease Crohn’s, the company said.