In Conversation with Praxis SCI Accelerate Cohort Member: Dignify Therapeutics

Founders’ Journey: From Pharmacology to Patient Impact

For Karl Thor and Ed Burgard, co-founders of Dignify Therapeutics, the path to spinal cord injury (SCI) research was anything but linear.Karl began his career in pharmacology, studying neurotransmitters and reflexes that control the lower urinary tract. His career took him from academic labs to an NIH staff fellowship to senior roles in the pharma industry. But large pharmaceutical companies weren’t interested in developing drugs for bladder and bowel dysfunctions in SCI, because it is a small and unrecognized market.

“Nobody grows up saying they want to study the bladder,” he laughs,  “but once I got into the lab and realized how many different transmitter systems were at play, I found it fascinating with many druggable targets available.”

That unmet need stuck with him. Together with Ed Burgard and a number of other long-time colleagues and friends who also had strong backgrounds in neuroscience research, the team founded Dignify Therapeutics to develop better solutions for bladder and bowel dysfunction associated with neurological conditions, issues that remain among the most significant quality-of-life challenges for people with SCI.

For Karl, the mission became even more personal when, just over a year after founding Dignify Therapeutics, his son sustained a spinal cord injury.

Learning from Lived Experience  

Through the Praxis SCI Accelerate program in 2024, Dignify gained direct inputs from people living with SCI. This reshaped the startup’s approach to the drug development program.

Focus groups also highlighted other factors that hadn’t been at the forefront of people’s minds. Predictability mattered more than speed; some participants preferred a drug that worked in ten minutes rather than immediately, to allow time to prepare. Others stressed that daily use wasn’t necessary; every-other-day or every-three-day routines could be just as effective, depending on the individual.  Even social considerations came up, from flatulence to the stigma of leakage.

“We realize just how much these challenges affect daily life, not only medically but socially,”  Karl Says

Adapting the Clinical Trial Strategy

The insights from Praxis influenced Dignify’s clinical trial design. To make participation less burdensome, the team limited clinic visits, overnight stays, placebo use, and broadened eligibility to include participants who use a variety of bowel care methods.

They also added a Phase I clinical trial in healthy volunteers before moving to the SCI population, responding to feedback that many in the community were reluctant to be the very first to try the drug.

“These adjustments made our program much more realistic. We want to respect people’s time and challenges, while still getting the data we need.” 

Beyond Research: Credibility and Connections  

The benefits of Praxis went beyond clinical insights. The non-dilutive funding support provided by Praxis offered valuable flexibility, allowing the team to cover not just research costs but also critical business needs, such as attending investor meetings.

Equally important were the introductions to investors and key opinion leaders.“One of the most valuable outcomes was being connected to SCI Ventures,” Ed notes.

“That was a direct line to potential funding, which is always our biggest need.” For Karl, the prestige of being chosen for the program was also meaningful.  

“Praxis is a very competitive program. Being selected validated us in the eyes of investors and partners. It showed we were serious players in the SCI therapeutics space.”

Standing Apart in a Neglected Field  

Today, bowel management options for people with SCI are limited to manual bowel programs, suppositories, and enemas that are unpredictable in the onset and duration of  action, which can promote fecal incontinence, or irrigation systems that are cumbersome and invasive.

Dignify’s approach is different. Their drug candidates are designed to provide convenient, predictable, efficient, and discreet bowel emptying, a therapy that could dramatically reduce time spent on bowel routines, lower incontinence episodes, and restore confidence in daily life.  “If this drug works as we believe it will be paradigm-changing. Nothing else out there compares.”

Building Lasting Relationships  

For both Karl and Ed, one of the most rewarding aspects of the program was the ongoing connection with Praxis PLEX Leaders, individuals with lived SCI experience who provided them with insightful inputs throughout the Praxis Accelerate Program.

“Meeting with our Praxis mentors Peggy, John and Chantelle every week was invaluable. We didn’t just learn from them; we built a relationship. That personal connection is something we’ll carry forward.”

Advice for Other Start-ups  

When asked what advice he would give to other startups considering Praxis, Karl doesn’t hesitate: “If you’re serious about making an impact in SCI, Praxis is absolutely worth it.”

About Dignify Therapeutics

Dignify Therapeutics, based in North Carolina, USA, is developing two novel drug programs to treat functional bowel and bladder disorders. Central to both programs is the concept of “convenient, on-demand, rapid-onset, short-duration, drug-induced defecation and urination”, where an individual can choose the appropriate place and exact time of voiding. This approach not only induces voiding for people with urinary and fecal retention but can also reduce incontinence accidents by allowing people to proactively empty their bowel or bladder when desired.