RESEARCH TRIANGLE PARK, NC (RTP) – February 26, 2014 – Dignify Therapeutics LLC, a Triangle-based drug development company focused on restoring bladder and bowel control to people with spinal injury, spina bifida, and other neurological conditions, announced the kick-off of their private equity solicitation today.
Dignify Therapeutics is developing novel pharmaceutical treatments for bladder and bowel dysfunction in people with spinal cord injury, spina bifida, multiple sclerosis, and other neurological conditions. Many people with these conditions require multiple daily urethral catheterizations to void urine and digital extraction to void stools. Catheter-associated infections and related morbidity require hospitalization of 1 of 8 catheter users on an annual basis resulting in approximately $350 MM in annual health care costs. The Company estimates the worldwide market potential for its lead product, DTI-100, which targets people with spinal cord injury, is approximately $400 million annually. Dignify Therapeutics is unaware of other companies developing pharmaceuticals to provide a rapid, on-demand, drug-induced voiding as a therapeutic strategy.
Dr. Karl Thor, President and Chief Scientific Officer, and Dr. Eboo Versi, Chief Medical Officer explained, “The severe unmet medical need associated with bladder and bowel care in people with spinal conditions, coupled with an absence of competition from big pharma or biotech pipelines, provides Dignify Therapeutics with a number of competitive advantages. First, it provides an opportunity to apply for Orphan and/or Fast-track designation with the FDA, which allows Dignify to work closely in cooperation with the FDA to develop and approve effective therapies as expeditiously as possible without compromising safety. Second, there should be a strong appetite for our products if and when marketing approval is granted. Third, it is an attractive therapeutic target for non-dilutive research funds from the NIH, Department of Defense, and patient advocacy foundations. Finally, it provides a highly motivated population of otherwise healthy, active people, who demonstrate strong determination, to live their lives as fully as possible. Sharing their enthusiasm for restoring voluntary control over their bladder and bowel provides Dignify Therapeutics a strong partner in bringing our products to market and into their hands. We hope that people with spinal conditions will help spread the word about our company’s $1.5 million fundraising amongst themselves through their grass roots advocacy networks.”
Mr. Benny Ward, Chief Executive Officer explained, “We plan to use the $1.5 million from investors to conduct the required studies to accelerate our lead product candidate, DTI-100, through the IND approval process and into clinical trials. We hope to attract investors who bring both financial and intellectual resources, such as experience in the health care industry as well as those who have a ‘personally vested’ interest in putting a product in the hands of people that not only have a spinal condition themselves but also a loved one with a condition, or physicians and caregivers who deal with the burden of providing bladder and bowel care on a daily basis for their patients.”. Mr. Ward further explained, “The Company currently plans is to attract non-dilutive funding for most of the additional funding beyond the $1.5 million that will be required to develop DTI-100 up to Phase III and out-license to a larger pharmaceutical company.”
About Dignify Therapeutics LLC
Founded by a team of serial entrepreneurs who are internationally-recognized scientists and clinicians, Dignify Therapeutics’ mission is to provide safe and effective, practical and convenient, “on-demand” pharmaceutical agents to treat bladder and bowel voiding dysfunctions, using a “repositioning” strategy of drug discovery that the team has successfully implemented multiple times over the last 20 years in the fields of urology and gastroenterology. Funding to the Company has been provided by the North Carolina Biotechnology Center, an entity primarily funded by the State of North Carolina.
Karl Thor, PhD
P.O. Box 13169 – 2 Davis Drive
Research Triangle Park, NC 27709