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NIH Puts $4.1 million in Dignify's Bladder, Bowel Therapy

By Barry Teater, NCBiotech Writer


Dignify Therapeutics, a drug development company focused on restoring bladder and bowel control for the elderly and for people with spinal injury, multiple sclerosis or diabetes, continues to draw federal grants from the National Institutes of Health for its research and development.

During the first three quarters of 2017, the Research Triangle Park company has received three NIH grants totaling $4.1 million from the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute on Aging. The funding was awarded through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, which help fund the commercialization of new innovations.

The latest grants support the development of Dignify’s lead therapy, DTI-100, intended to eliminate or reduce the need for life-long, multiple-daily catheterizations of the bladder and manual bowel programs.

“The DTI-100 program represents a series of related molecules that can produce on-demand, short-acting, drug-induced voiding for those individuals unable to voluntarily control voiding,” said Ed Burgard, Ph.D., president and CEO of Dignify. “The DTI-100 program is designed to produce voiding within minutes of dose administration, and be cleared from the body minutes later – a novel concept.”

Ready to test safety in humans

Dignify is preparing for a Phase I clinical study of DTI-100, as well as studies to identify alternative formulations, through collaboration with the Division of Pharmacoengineering and Molecular Pharmaceutics at the UNC Eshelman School of Pharmacy.  The clinical study could start as early as the first quarter of 2019 “with appropriate funding,” Burgard said.

Worldwide catheter sales total $3 billion per year, while health care expenditures associated with voiding dysfunction cost $7 billion per year in the United States, according to the company.

“Thus, success of Dignify’s lead drug development program will not only improve the quality of life for individuals with voiding dysfunction, it will also substantially reduce health care costs,” the company said in a news release.

In addition to DTI-100, Dignify has three follow-on programs to treat bladder and bowel disorders. 

Dignify’s 2017 funding follows earlier NIH grant support totaling $4.3 million between 2013 and 2016. That funding came from four NIH agencies: the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute of Neurological Disorders and Stroke, the National Institute on Aging and the National Institute of Diabetes and Digestive and Kidney Diseases.

“We are very appreciative of our continued support from the NIH,” said Karl Thor, Ph.D., Dignify’s chief scientific officer.

The North Carolina Biotechnology Center has supported Dignify with $300,000 in loans: 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 the preclinical development of DTI-100.

The Center’s funding helped Dignify attract $3.15 million in equity financing from RA Capital Management, Eshelman Ventures and angel investors. The company also received $115,000 from the One N.C. Small Business Program of the N.C. Department of Commerce

Dignify, a member of the Blackstone Entrepreneurs Network, is located in the First Flight Venture Center.

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