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ReNeuroGen: Innovators in action

By Anna Lardinois

Startup Storyteller

Brett Favre and a local pharmaceutical company have a common goal: to prevent the devastating effects of CTE.

Chronic Traumatic Encephalopathy (CTE) is a progressive brain condition that’s caused by repeated blows to the head and recurrent episodes of concussion. Those who suffer from the brain injury may experience mood swings, memory loss, and significant loss of executive function.

The condition has plagued the NFL, and other contact sports, and high-profile athletes, like Favre, are at the forefront of a movement to prevent brain injuries by restricting the age of contact play for athletes and improved safety gear.

ReNeuroGen hopes to add another tool to the plan to combat the devastating effects of CTE.

The company was founded in late 2016 on the foundation of Dr. Kirk Pritchard’s work at the Medical College of Wisconsin. Pritchard has been working on the inflammation inhibitor KYC since 2010. When the company was formed, the professor of pediatric surgery was joined by Dr. Stephen Naylor, the founding director of Mayo Clinic’s Mass Spectrometry Center.

Naylor describes Pritchard as the “engine of discovery” for ReNeuroGen. Dr. Billy Day, described as an “internationally renowned medicinal chemist,” joined the company in 2018. The team has been augmented by a collaboration with Dr. Kevin Rarick, a research professor in critical care at the Medical College of Wisconsin. This team, with the aid of a few respected contract research organizations, are on the cusp of working with the U.S. Food and Drug Administration to submit their Investigational New Drug Application. Approval of this application means the company can begin testing its ground-breaking drug, believed to have positive effects against CTE, on humans.

The path to take a drug from the laboratory to the pharmacy shelf is an arduous one.

“Trying to bring a drug to market anywhere in the world is horrendously difficult,” Naylor said. “On average, it takes anywhere from 10 to 15 years to actually get that drug to market. The often-quoted average cost these days of getting the drug to market is about $1.5 billion.”

Naylor notes ReNeuroGen’s advantage over their big pharma competitors is that “a smaller company, where you are much more flexible and nimble, can get a drug to market for much less, but it’s still over $100 million .”

The Milwaukee-based company has used its size to its advantage. ReNeuroGen calls itself a “virtual pharmaceutical company,” which Naylor defines as, “we keep our management teams small, and then we rotate people in and out in regard to their expertise, depending on where we are in the evolution of the company’s progress of getting the drug to market in a particular disease indication.”

Using experts in their field has allowed the company to move more quickly through animal studies, while still following the strict protocols and methodologies that the FDA requires.

When Naylor speaks of disease indication, he is referencing the host of diseases that KYC has shown promise in treating. The Inflammation inhibitor is showing positive effects against sickle cell disease, Multiple Sclerosis, Bronchopulmonary Dysplasia (a lung disease that impacts premature babies), and brain injuries that include traumatic brain injuries, and some injuries that result from stroke, in addition to those caused by CTE.

Naylor estimates the discovery stage in drug development can take five or six years, which is followed by a two-to-three-year animal studies preclinical stage. ReNeuroGen is nearing the end of the preclinical stage and hopes to move into the human trials development stage, which he says “can take up to five or six years. That’s how easy it is to get up to 10 or 15 years to get the whole drug discovery to market timeline.”

The challenge of developing a new drug begins in the laboratory, but what happens in the boardroom is just as critical to the success of the drug. Money is needed to fund the years of work it takes to develop a new drug and finding the large sums of money needed to move a drug forward is a herculean task.

“If you’ve got money, you can get things done a lot faster,” Naylor said. “Part of the reason that things take so long for smaller companies is you’re doing two things simultaneously. You’re developing a drug from a scientific, and clinical perspective, but you’re also having to go out and raise more money.”.

He continued, “raising money around drug discovery and development is not trivial.  It takes time and is contingent on previous success. It is like a water faucet, a drop, drop at a time. But imagine if you had immediate access to $100 million that’s needed to get the drug all the way through preclinical studies and into human trials. The time to market now gets concentrated and compressed.”

ReNeuroGen has entered the Wisconsin Governor’s Business Plan Contest in hopes of catching the attention of the NFL, an organization that has been affected by CTE. Naylor hopes a sizable investment from this organization is beneficial to both parties, as the influx of capital will speed the timeline for the release of the drug and provide relief for those who suffer from CTE sooner.

To learn more about ReNeuroGen and its groundbreaking drug candidate KYC, click here.

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