Dr. Jurgen Luders connected years ago with Golden, Colo.-based Reven Pharmaceuticals Inc. after a friend and former colleague at the Cleveland Clinic told him about his own involvement with the company. Luders visited Reven to learn more and ended up joining its advisory board. He later became medical director at Reven, which is developing a powerful anti-inflammatory drug called Rejuveinix, or RJX, that shows promise in preventing and reversing conditions caused by inflammation. Luders — the chief of neurosurgery at Mercy Health Hauenstein Neurosciences who is board certified in regenerative medicine — spoke with MiBiz about his work with Reven, RJX’s potential for treating COVID-19 patients, and innovation in health care.
What’s the promise of Rejuveinix, the drug you’re involved in developing?
If you look at most disease processes, the majority have a basis in inflammation. For example, if you look at plaque buildup in blood vessels, that’s an inflammatory response in the blood vessels. That’s your body producing that. If you can help that, then all of a sudden you’re able to treat any heart disease, cerebrovascular disease, cardiovascular disease and peripheral vascular disease, so you’re preventing heart attacks and strokes. That in itself is massive.
You can also prevent other inflammatory diseases such as Crohn’s, which is an inflammatory bowel disease, and multiple sclerosis, which is an autoimmune disease. Those are all things we’ll be able to treat. It’s a total game-changer.
The company also indicates that RJX can treat diabetes. What has your testing shown there?
We treated more than a thousand patients in South Africa on a compassionate care basis with critical limb ischemia — people who have real bad diabetes and they lose their limbs. Every single one of them, we saved their limbs.
It is a massive problem in this country and the cost to our health care system is massive. What this drug will do is reverse the need for that kind of intervention. (RJX) demonstrated dramatic improvement in wound healing of diabetic limbs as well as reversing diabetic neuropathy. FDA Phase 1 trials in 76 healthy patients (in the U.S.) showed not only no significant adverse effects but also a significant drop in inflammatory markers, in addition to dropping blood sugar levels on average 10 points.
How has the COVID-19 pandemic affected the development of RJX?
We were about to start our Phase 2 clinical trial for critical limb ischemia right when COVID hit. That was a trial that was going to look at wound healing and reversing peripheral vascular disease for critical limb ischemia.
The FDA changed its rules. You weren’t allowed to start a new Phase 2 trial unless it was for COVID purposes, which is kind of ironic because the more information that came out about COVID, the more we realized it isn’t the virus itself that causes all of the problems, it’s this inflammatory cytokine storm that occurs and causes acute respiratory distress, and that’s what causes damage to your lungs, heart and liver. So, we went to the FDA to see if we can treat COVID patients with RJX.
What response did you get?
We have four submissions to the FDA. Two Investigational New Drugs — one for critical limb ischemia and the second for COVID-19, which we just received a letter from the FDA stating their plan to expedite the review. We’re hoping to start our Phase 2 trial for COVID-19, hopefully, by early November.
What are the innovations coming out in your field of neurosurgery?
When you’re talking about innovation from a neurosurgical perspective, along the lines of brain surgery and spine surgery, some of the biggest advancements we’re seeing right now are in the field of robotics and navigation and imaging techniques. For example, when we put screws in someone’s back, we used to do it free hand. Now we have a full navigation system that really helps speed up the surgery and makes it much more precise, which allows for a quicker surgery where you’re going to have less blood loss, better outcomes and a lower risk.
As a surgeon, I love these new innovations. It allows us to go further forward than we were ever able to before, and we can do it in a safer way and we can do it quicker.
Are we in a new era of innovation in medicine?
I think we are, but I would say the new era is beyond improving on surgical performance. Where this is taking us in the next 10-20 years, there’s going to be a huge revolution in health care and medicine from a scientific perspective.
Do you see the pandemic creating a greater emphasis on wellness and health prevention or accelerating research and innovation?
The biggest thing that I find in this is that people in general are much more interested in their own health and wellness. This has really brought that to the forefront. It’s interesting as of late we’ve gotten much more interest in our wellness center. I can tell you, the most important thing for anyone’s health is a desire to be healthy, being active and improving your diet.
I’ve seen a super-increased interest in people taking care of themselves, and once it starts there, then innovation in health care is going to be there.