Regentys, Cook Biotech to Collaborate in Developing, Delivering Unique Ulcerative Colitis Treatment

Regentys recently announced it will partner with Cook Biotech Inc. to develop a novel treatment for ulcerative colitis. Under the terms of a signed letter of intent, Cook Biotech will develop and manufacture Regentys’ licensed clinical product,

ECMH™ Rectal Solution (Extracellular Matrix Hydrogel), which will be used in first-in-man clinical studies conducted by Regentys in 2018. As part of the partnership, Cook Biotech has become a stakeholder in Regentys.

“We are excited to partner with a world-class organization like Cook Biotech,” said Regentys Chief Business Officer Brian Andersen. “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. Cook Biotech’s experience in the production of ECM is unmatched. They have successfully produced commercial products that have been used, and are currently being used, to treat patients worldwide for more than 20 years.”

“This is a unique application of ECM that will help treat a very debilitating disease,” said Cook Biotech President Umesh Patel. “We’re looking forward to working with the team at Regentys to bring this product to market.”

Ulcerative colitis, one of the two major forms of inflammatory bowel disease (the other being Crohn’s disease), is characterized by chronic diarrhea, pain, bleeding, urgency, and an increased risk of cancer. Research shows that an estimated 900,000 U.S. residents, and more than 1.3 million people worldwide, are currently diagnosed with ulcerative colitis.

Ulcerative colitis exacts a heavy societal toll on personal and financial health. Estimates put the total economic burden from ulcerative colitis at $8.1 to $14.9 billion in the U.S. alone. Even with the introduction of high profile and costly immunomodulators, statistics reveal that 20-30% of ulcerative colitis patients require surgery to remove their colon as a form of therapy. There is a genuine need for a new and different treatment approach to ulcerative colitis.
Regentys holds an exclusive, world-wide license for ECMH™ Rectal solution, a patented, non-surgical hydrogel therapy for sufferers of ulcerative colitis that is delivered directly to the affected area as a liquid that gels upon reaching body temperature, forming a protective barrier that acts as a scaffold for natural tissue recovery to occur.

To further support its developing solution, Regentys recently completed a pivotal animal study to confirm earlier, proof-of-concept studies. This compelling, statistically significant data, published in the Oxford Journal of Crohn’s and Colitis, showed that the use of ECMH™ Rectal Solution “established proof of mucosal regeneration and reduction in inflammation and ulceration, in addition to restoration of the cell barrier function and reduction in inflammatory biomarkers.”
Regentys will utilize these results as the basis for a regulatory filing to commence its clinical studies.

Cook Biotech Inc. develops and manufactures advanced tissue-repair products. Cook Biotech’s products are derived from proprietary extracellular matrix (ECM) technology using proprietary manufacturing processes. ECM, a naturally occurring biomaterial, possesses tissue-remodeling properties. Cook Biotech products are used globally to treat multiple types of wounds (e.g., burns, non-healing chronic wounds, diabetic wounds) and for patient treatments including hernia repair, fistula repair, otologic repair, and soft-tissue reinforcement. Cook Biotech sells its ECM products under several brands, including Biodesign and OASIS. Cook Biotech is part of the Cook Group, which includes Cook Medical in Bloomington, Indiana. Cook Biotech is located in the Purdue Research Park in West Lafayette, Indiana. It was established in 1995 following a Purdue University biomedical engineering research team’s discovery of the tissue-remodeling properties of ECM. For more information, visit http://www.cookbiotech.com.

Regentys (formerly Asana Medical, Inc.) is a regenerative medicine company developing a tissue-engineered therapy for the treatment of ulcerative colitis. The company’s product, ECMH™, a novel application of a proven technology, will be a first-in-class therapy for patients suffering from ulcerative colitis. This therapy will offer a distinct departure from the current methods of treating ulcerative colitis patients in a multi-billion-dollar market dominated by immunosuppressive biologic and drug therapies that can have significant side effects. Additionally, 20-30% of patients do not benefit from these therapies and have no alternative except colon removal surgery. Regentys has an experienced management team, strong patent protection, world-class scientific and medical partners, and compelling preclinical proof-of-concept data. For more information, visit www.regentys.com.