New Hope for the Treatment of Diabetic Foot Ulcers

Author: Sarah McCafferty

In America, more than a million people suffer from diabetic foot ulcers.

In Latin, SalvePeds means “saving feet.” 

And in SalvePeds, a new IDEA Center startup managed and marketed by a team of graduate students at the University of Notre Dame, patients may soon have a more effective option to treat diabetic foot ulcers and prevent some of the 100,000 amputations the condition necessitates every year.

An estimated one in four diabetes patients will develop foot ulcers during their lifetimes. Diabetic foot ulcers are notoriously difficult to heal, often resulting in lower-limb amputations. The wounds do not heal properly because of a protein that results in prolonged inflammation, and current treatments do not address this root problem. 

Mobashery And Chang At Computer

The topical gel, ND-336, developed by Notre Dame researchers Mayland Chang, Research Professor of Chemistry and Biochemistry, and Shahriar Mobashery, Navari Family Professor in Life Sciences, addresses the underlying condition by counteracting that protein, thus inhibiting the breakdown of tissue so the wound can heal. The compound was developed in the labs at Notre Dame, and is currently being tested in preclinical animal trials. 

“Cognizant of the unmet clinical need surrounding the effective treatment of diabetic wounds, we directly addressed the issue of why diabetic wounds are difficult to heal through pharmacological intervention,” Mobashery explains. “This was the scientific genesis and foundation of SalvePeds.” 

The only currently approved drug, Regranex, has modest efficacy and comes with an increased risk of cancer and mortality — on top of the already high one-year-mortality rate of diabetic amputees, sitting currently around 50%. 
SalvePeds presents a new solution to this problem. Early pre-clinical results show the topical gel to be 150% more effective than Regranex, and 200% faster than a placebo. 

“I am interested in studying diabetic foot ulcers for personal reasons,” Chang said. “My mother, and my aunt who took care of me as a child so that my mother could help my father in the family business, both had diabetes and died prematurely. My sister has diabetes and I am prediabetic. I hope that our compound can make a difference in the lives of patients with diabetic foot ulcers.”

The head of SalvePeds is Notre Dame graduate student Trung Nguyen, a PhD candidate in biochemistry who has been working with Drs. Chang and Mobashery for five years to develop the drug. Also on the management team are Raja Krishnan, an MBA student with a BS in Chemical Engineering, an MS in Pharmaceutical Science and an MS in Law; and Melissa Connolly, an ESTEEM student with a background in biochemistry. 

With diabetes rates nearly doubling in the past two decades, from 5.5 percent of Americans in 1994 to 9.3 percent in 2012, the Centers for Disease Control and Prevention predicts that one in three American adults will suffer from this disease by the year 2050. As the number of patients with diabetes continues to rise, so will the occurrences of diabetic foot ulcers – and so will the number of people who could benefit from this product.

The company is currently initiating an Investigational New Drug application with the Food and Drug Administration, and plans on being in phase I clinical trials as early as 2019. They are in the process of actively raising funds to help carry out these clinical trials.  

SalvePeds has progressed to, and is competing in, the second round of the McCloskey New Venture Challenge at Notre Dame. SalvePeds was also recently invited to the Rice Business Plan competition, the world’s richest and largest startup competition, where they are set to compete from April 5-7 in Houston. One of 42 teams selected from a 375-applicant pool, SalvePeds is the only team from Indiana chosen to compete for $1.9 million in prizes in front of 300 judges, a panel that includes angel investors, venture capitalists, CEOs, industry specialists and NASA special judges. 

“It is extremely difficult to get selected for the competition as a pharmaceutical startup, and we are excited for this amazing opportunity to showcase the research and entrepreneurial spirit at Notre Dame,” Nguyen said.  
 

Originally published by Sarah McCafferty at ideacenter.nd.edu on April 01, 2018.