RESEARCH TRIANGLE PARK – Dignify Therapeutics, a pharmaceutical and medical device development company in Research Triangle Park focused on restoring bowel and bladder control for elderly and neurologically impaired people, has added a new compound to its product pipeline.

The company has signed an in-licensing agreement with Aayam Therapeutics of San Jose, Calif., to develop Aayam’s ATX-003, a compound for on-demand defecation, and related proprietary molecules.

“This agreement provides Dignify with a novel treatment to add to its expanding therapeutic pipeline for bowel and bladder disorders,” said company President Ed Burgard, Ph.D., “ATX-003 is a significantly de-risked therapeutic that will extend Dignify’s patent protection as well as provide therapeutic benefit for individuals with constipation and functional bowel disorders.”

Health care expenditures associated with voiding dysfunction cost $7 billion per year in the United States alone, according to Dignify.

Dignify Therapeutics

“Constipation and functional bowel disorders are serious issues that patients face and seriously affects their quality of life,” said Sundeep Dugar, Ph.D., president of Aayam. “There are no real therapies available for these patients. We are excited to work with Dignify to advance a safe and effective therapy for this serious and unmet need.”

Dignify’s void-on-demand drug candidates are intended to eliminate the need for urinary catheterizations, manual bowel programs and colostomies. Targeted populations are the elderly and people with spinal cord injuries, spina bifida, multiple sclerosis, stroke, Parkinson’s disease and diabetes.  These individuals account for much of the $19 billion U.S. market for incontinence products.

Earlier this year Dignify received a major federal award to advance another drug candidate for treating bladder and bowel dysfunction.

The four-year collaborative grant from the National Institutes of Health will provide over $4 million to support the pre-clinical and clinical development of DTI-117, a novel neuropeptide that can induce on-demand voiding when taken sublingually, or under the tongue.

The company is also developing DTI-301, another voiding stimulant delivered as a suppository.

Dignify is funded by its founders and venture capital investments from RA Capital Management of Boston and Eshelman Ventures of Wilmington. It has also received over $20 million in government funding, including grants from the NIH’s SBIR/STTR program and related support from the N.C. Department of Commerce’s One North Carolina Small Business Program.

The North Carolina Biotechnology Center has supported Dignify with two awards: a $50,000 Company Inception Loan in 2013 to help establish the company and a $250,000 Small Business Research Loan in 2014 to support preclinical drug development.

Dignify is located at the First Flight Venture Center in Research Triangle Park.

(C) N.C. Biotech Center