Success Story

Penn State research-based startup moving to clinical trials for diabetic wound treatment

People with both Type 1 and Type 2 diabetes often experience suppressed wound healing. This means that for 25% of diabetics who get a foot ulcer, an open sore that’s usually located on the bottom of the foot, the wound tends to worsen, making it exceedingly difficult to treat.

Penn State research-based startup ElkosRx is working to bring their topical treatment for early-stage diabetic foot ulcers to the market.

“Most of the effort in the field is in late-stage wounds, which get infected and are harder to treat, so the probability of success is really low,” ElkosRx co-founder and CEO Mark Lane said. “There is this unmet need for a treatment that targets these early-stage wounds to improve the quality and speed of healing, and that will hopefully reduce the recurrence and severity of wounds.”

Drs. and ElkosRx co-founders Patricia McLaughlin, Joseph Sassani, and Ian Zagon at Penn State College of Medicine found through their research that a pre-existing generic oral drug known as Naltrexone can be re-purposed for topical use to speed up the wound healing process for diabetic foot ulcers.

“Following our discovery of elevated serum levels of Opioid Growth Factor (OGF) leading to reduced wound closure, we are particularly excited that we can restore these biological tissue repair processes to normal in diabetes patients using a topical therapy,” said Dr. McLaughlin. “Furthermore, knowing that this therapy is safe and effective, as well as FDA-approved for other purposes, is very gratifying.  We are planning on a fast-track to clinical trials in the near future.”

Because the drug has already been tested for safety, ElkosRx has been able to follow an abbreviated pathway for regulatory approval to use the drug as a topical treatment.

Most recently, the ElkosRx team successfully completed a formulation known as a GNP formulation, which the FDA has reviewed and approved for use in a clinical trial.

“The really interesting thing about this company, in addition to the fact that it’s a low-risk, quick path to the market, is that we have been able to get to this point where we can enter into clinical trials with just small grant funding,” Lane said. “We really moved very quickly and efficiently.”

ElkosRx is a current participant in the Invent Penn State Startup Leadership Network’s 2022 Board of Advisors program.

“The advisory board consists of experts in non-clinical, regulatory, commercialization, reimbursement – all things that are very important for us as we bring this potential therapy to the market,” Lane said. “We’ve got a really fantastic board of advisors that provided us with lots of good insights into things we could do better and maybe differently as we progress.”

The startup has also worked with the Penn State College of Medicine’s Center for Medical Innovation for advice and support.

Lane said ElkosRx is currently working to raise funds to conduct their first clinical trial, which will be their next major milestone as a company.

“Penn State researchers looking to commercialize should interact with the Startup Leadership Network,” Lane said. “You have to carefully define the problem that you’re solving when you’re first starting out. Take an initial look at the marketplace to make sure you are addressing an unmet need. The Startup Leadership Network can help with that. It can be challenging to go from doing research in the lab and moving towards experiments that serve drug development, so it helps to get outside perspective.”

The Startup Leadership Network is a signature program offered by the Penn State Office of Entrepreneurship and Commercialization. Click here to learn more.

About Invent Penn State

Invent Penn State is a commonwealth-wide initiative to spur economic development, job creation and student career success. Invent Penn State blends entrepreneurship-focused academic programs, business startup training and incubation, funding for commercialization, and university / community / industry collaborations to facilitate the challenging process of turning research discoveries into valuable products and services that can benefit Pennsylvanians and humankind.