Durham, NC | Benny Ward | www.dignifytherapeutics.com
We really appreciate the support of the SBTDC and think it’s a great organization for early-stage technology companies that just need someone to show them the path to getting the company off the ground and funded through these SBIR/STTR opportunities.
WHAT THEY DO Founded in 2013, this start-up pharma company is working on an innovative new drug designed for patients with bladder and bowel voiding dysfunction. Their target patients primarily include those with spinal injuries and diseases including spina bifida and multiple sclerosis, but may expand to include the institutionalized elderly. For many of these individuals, their caregiver must insert a bladder catheter four or more times a day in order to empty their bladder. These patients often end up with additional complications as a result. Benjamin Franklin invented the bladder catheter in 1752 and, until now, there haven’t been any advances in technology since. With Dignify Therapeutics’ new drug, these patients would be able to place a tablet under their tongue or spray the solution into their nose, empty their bladder and bowel and move on with their lives. It’s an on-demand therapy with rapid onset and rapid clearance from the body, meaning patients can choose when and where to void and have more time for themselves. They may no longer need a caregiver and their lives will improve dramatically as a result.
UNDER THE CAPE Benny Ward, the business executive at Dignify Therapeutics, joined the team with an impressive resume. His first encounter with the start-up tech world was while auditing various industries for Price Waterhouse. In 1996, he joined one of these companies as controller to take the company public. They developed an adhesive for the skin to replace sutures and staples that ultimately came to be known as Derma-Bond. After that, he worked to start several other firms before joining Dignify Therapeutics in 2013.
At Dignify, the rest of the team is made up of scientists and PhDs with expertise in urology, neuroscience and medicinal chemistry. They are focused on developing their product while Benny works the business angle. He helped establish the company and ensures they have the funding and resources they need to continue.
GREASING THE WHEELS As with all tech companies, the initial challenge is finding the funding necessary to bring the technology to a point where others see it as a worthwhile investment. The SBTDC has the experience and resources to help companies find and successfully apply for technology-development capital. Before Benny came on board, the SBTDC helped Dignify write a business plan and SBIR/STTR grant application, landing them $150,000. Benny says, “We really appreciate the support of the SBTDC and think it’s a great organization for early-stage technology companies that just need someone to show them the path to getting the company off the ground and funded through these SBIR/STTR opportunities.” Since then, they have received close to another $10 million in funding from the NC Biotech Center, institutional investors and SBIR/STTR grants from four separate branches within the National Institutes of Health (NIH).
INTERNS DETERMINE VIABLE MARKETS Beyond the drug’s original intended use for spinal cord injury patients, the team is constantly evaluating additional markets. Before those sparks of inspiration can be viable, however, they have to analyze the market to be sure there would be enough demand before committing to time consuming and costly drug testing. This is where SBTDC interns have come in handy. Two summers ago, an intern at Dignify performed the market research for surgery patients requiring anesthesia that inhibits bladder emptying. Before being released from the hospital, patients are required to relieve themselves, and this drug could stimulate bladder emptying and allow for less time in the hospital. The intern researched the market size and potential for commercialization and found that this is indeed an avenue worth studying. Benny says, “We had no understanding of that market, and our intern was able to put together an assessment and presentation of the market that we presented to our board. They supported going forward with that opportunity.” Dignify had a second intern this summer whose focus was on the institutionalized elderly market.
NEXT STEPS Dignify’s drug development program is still in the pre-clinical stage but they hope to be testing in humans within two years. That study will enroll healthy human volunteers to test for side effects before testing spinal cord injury patients and the post-operative urinary retention patients. After that will be a large-scale study. Their plan is to find a commercialization partner before starting on the large-scale study, which would allow them to create the maximum value for the product before outlicensing it. Dignify also has follow-on products in the works to start developing.
CHAMPIONS OF IMPROVED LIVES Apart from walking, for many spinal cord injury patients, bladder and bowel function is one of the most important aspects of their lives. The amount of time necessary to use the catheter four to five times a day and the reliance on the aid of a caregiver can keep them from holding jobs and otherwise leading relatively normal lives. Additionally, many of these individuals often have related issues from skin exposure to urine and from the daily use of the catheter. These issues could be eliminated. For the Dignify Therapeutics team, that is what keeps them motivated. “I think we can really make a difference in people’s lives. That’s what we’re trying to do and that’s what we’re passionate about.”
This story was originally published in the SBTDC 2018 Success Stories. View the entire publication here.
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