Repairing the Spine: Q&A with Mike Kelly, CEO of NervGen

Mike Kelly
President and CEO
NervGen

Spinal cord injuries (SCI) can be devastating. Victims can often be left with permanent disabilities and debilitating pain. Mike Kelly, president and CEO of NervGen, spoke with Pharmaceutical Executive about the company’s unique approach to actually repairing these injuries. The company’s primary drug, NVG-291, has shown the ability to activate the body’s ability to heal itself.

Pharmaceutical Executive: How did you become involved with NervGen?
Mike Kelly: I’ve been in pharma for about 30 years, starting off on the commercial side of the business. For my last several jobs, I was at the executive level at different companies. At my last job, I was involved in launching the Narcan nasal spray. I joined NervGen after a friend of mine introduced me to the company and said I should look at the technology. I got in touch with the company’s founder Dr. Jerry Silver and had a fantastic conversation. We booked a half-hour and an hour-and-a-half later, Jerry realized he had to leave because he had another call to get to.

Jerry is a great inventor, but he’s also a fantastic teacher. Since I’m not a scientist, he’s been able to take complex science and break it down so he can educate a non-scientist like me about his technology and the series of discoveries he made that led to NVG-291.

Then I met the company’s founder, Dr. Harold Punnett. He started the company after his daughter-in-law fell and became paralyzed. Harold had been a dentist and had a science background, so he began searching the world for spinal cord injury treatments. This is when he discovered Jerry’s research. Ultimately, he convinced Jerry to out license the technology, got a group of investors together, launched an IPO, and started the company.

It's not your typical path for a biotech.

After I met with Jerry, I met the board and core management team. With each conversation, I became more excited that I could actually help the company. The skillset that I brought to the table would get the company to next level.

PE: How significantly can SCI impact a patient’s quality of life?
Kelly: There are 18,000 new cases a year, and there’s over 300,000 people living with these injuries, which can range from a minor motor-incomplete injury to a severe, full-paralysis injury. When people think of SCI, they think of someone like Christopher Reeve who was in a wheelchair and needed a ventilator. However, there are folks that had a small accident or sports injury. One of our board members was an avid bike rider. One day, he got run off the road by a truck and got a lot of different injuries. However, one small tweak of his spine left him in a wheelchair for the rest of his life.

The average age for people with SCI is 43. These are people whose lives changed in an instant. It’s pretty devasting to go from being fully functional to having a permanent condition. Some folks have minor injuries that leave them unable to grasp things. Other people are left with more severe injuries and are unable to walk or lose the use of an arm. They must very quickly figure out how to get through life impaired.

It’s not like a disease that has a slow onset. Something happens and these people very suddenly found themselves in a hospital being told that this is how things will be for the rest of their lives.

PE: How does NVG-291 differ from traditional SCI treatment?
Kelly: Traditional treatment is just rehab. There’s a lot of cutting-edge things that are starting to happen, but there is no pharmaceutical treatment. Our product works in a simple way. When you cut your hand or break a bone, your body repairs itself. If you damage your spinal cord, however, your body protects itself, and that inhibits repair.

One of the molecules involved in this protection process is CSPG, and this is where Jerry’s research came into play. He had discovered that these molecules could inhibit the repair process, so he started to look into how to turn these molecules off. Through a collaboration with Harvard, a receptor was discovered where these molecules were attaching to cells. He then began developing drugs that could disrupt that process, which is where NVG-291 was discovered.

We’re still trying to determine the specific molecular mechanism of action, but the action we’ve seen is that when the drug is introduced into a rodent model, it turns off those molecules and the body is able to regenerate. We’re not propagating anything; we’re just shutting off the inhibitor and allowing the body to the work on its own.