Developing Non-Addictive Pain Medication

Pharmaceutical Executive: Can you describe South Rampart’s work in pain medication?
Dr. Hernan Bazan: For several years now, we've been working on the development of a novel manipulated small molecule to reduce pain without having the addictive potential of opioids. We’ve submitted an IND with FDA to get into the clinic and are now working on phase two. Our molecules is ready in three different pipelines, and we are eyeing the very first one as acute pain. I'm the PI of two funded NIH grants. We just submitted two others in January and February of this year.

The NIH has had an incredibly supportive Small Business Office that has been very entrepreneurial with a lot of critical resources that have allowed small biopharmas like ours to move forward and go all the way from concept to pre-clinical characterization into the clinic.

PE: Since the situation with NIH is a bit unpredictable at the moment, how are you strategizing around that?
Bazan: The NIH has been an immense supporter of our work and of others in this field, particularly through the HEAL (helping end addiction long-term) Initiative, which was actually started by Congress almost six years ago. Our project is a prime example of taking academic knowledge and supporting it based on strong foundational science, coupled with significant commercialization plans that must be submitted. We also had to demonstrate to the study section about how the assets are going to be commercialized.

In these study sections, both researchers were neuroscientists and had good fundamental understandings of how to relieve pain in the brain or in the periphery. The set of sections were also grouped with individuals who had done this before, who had commercialized assets, so they understand the different obstacles that could occur. They knew what could happen. They evaluated us based on both their scientific rigor as well as the commercialization potential. And because it goes through such a thorough process, the funding rate has sometimes been in the single digits.

You learn a lot from the process, and you really streamline, so that as you execute, you're doing so the best way possible. There are a lot of market resources that they share through the EIR (entrepreneurs-in-residence) Program that can give you feedback on different things. It's a good networking opportunity. Obviously, you learn a lot from other people that are going through it.

In regard to what’s happening now with NIH, the main thing to do is diversify. You raise both non-dilutive funding through NIH which is the very best, obviously, and then as well as dilutive and to try to move the program forward.

PE:How risky is the traditional pain medication market still to this day?
Bazan: The pain market has really had a blemish on it going as far back as 15-to-20 years. I think there were not well-validated targets that were being developed based on not the most stringent science. When these molecules were being developed into clinical trials, the endpoints that were being utilized were questionable. One of the challenges with pain is that the endpoints are have to be really well designed, because pain is something that is subjective.

In clinical medicine, pain is something that a patient says that they feel. Your assessment of pain, your threshold, may be much higher than mine, or vice versa. It's so important when designing a trial to objectify something that's objective as much as possible. Clearly there's a science to that. There are individuals and a few groups that have had a lot of experience and success doing that, and that has obviously come with experience in the last 10-15 years.

I think we're now, fortunately, in a really good state.