Dignify Therapeutics Receives NIH Grant for Drug Development

Dignify Therapeutics, a pharmaceutical and medical device development company in Research Triangle Park, has received a major federal award to advance its main drug candidate for treating bladder and bowel dysfunction.

The award will provide over $4 million to support Dignify’s pre-clinical and clinical development of DTI-117, a novel neuropeptide that can induce on-demand voiding. 

The four-year collaborative grant was awarded by the National Institutes of Health (NIH) through its Blueprint Neurotherapeutics Network, which helps neuroscientists in academic labs and biotechnology companies to develop new drugs for nervous system disorders. Some of the funding will go to Dignify while some will be spent directly by NIH.

“This new award exemplifies the foresight of, and commitment from, the NIH to develop treatments for bladder and bowel dysfunction in people suffering from these conditions,” said Ed Burgard, Ph.D., principal investigator on the grant and Dignify’s president.

The funding will support the submission of an Investigational New Drug application to the U.S Food and Drug Administration and a subsequent clinical trial for DTI-117, Burgard said.

“A convenient and safe on-demand, rapid-onset, short-duration, drug-induced, voiding therapy would be a life-changing paradigm shift in treating bladder and bowel dysfunction for those who currently rely on life-long multiple daily catheterizations and daily digital bowel programs,” according to the company’s grant abstracts. 

Such patients can lose voluntary control over their bladder and bowel function due to a wide range of diseases and conditions including spinal cord injury, multiple sclerosis, Parkinson’s disease, spina bifida and stroke, as well as complications of aging and diabetes. Successful therapies and devices would improve the quality of life for these patients while reducing health care costs.

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

Dignify’s product pipeline includes two medical device programs and two drug programs, all supported by the NIH.

The company is funded by its founders and by venture capital investments from RA Capital Management of Boston and Eshelman Ventures of Wilmington. It has also received over $15 million from the NIH’s SBIR/STTR program plus 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.