Even if you’ve vaguely paid attention to the news, you’re aware that the United States is in the middle of an opioid crisis.
Deaths from synthetic opioids (primarily fentanyl) have skyrocketed in the last decade to overtake all other sources of fatal drug overdoses, and now account for about 80,000 deaths a year, according to the National Institute on Drug Abuse. Louisiana accounts for an outsized share of those deaths, ranking No. 3 in the country for fatal opioid overdoses.
A lesser known fact is that South Rampart Pharma, a New Orleans company, is among those on the cusp of getting a breakthrough non-opioid pain drug to market. Apart from the obvious societal benefits of pioneering a new class of non-addictive pain treatments, the potential financial benefits for those with successful drug patents are enormous.
Founded in 2016 by Argentina-born Dr. Hernan Bazan, a vascular surgeon at Ochsner Health, and his father Dr. Nicolas Bazan, director of LSU’s Neuroscience Center of Excellence, South Rampart has passed several key milestones in their quest to get their new drug into the marketplace. On the clinical front, the company is about to enter phase 2 testing of its main drug, called SRP-001 for now, with “fast track” approval from the Food and Drug Administration. If successful, that would leave just one final phase of testing on a broader human sample before getting market approval.
On the financial front, the company has raised a total of $9 million through a series of grants from the National Institutes of Health, as well as equity from Ochsner Health’s venture arm, and other sources, such as Louisiana’s research and development tax credit program.
Here, Hernan Bazan talks about the company’s journey and what’s next.
Interview has been edited for length and clarity.
First, just recount how you got started and the aims of South Rampart Pharma?
The company was started as a spin-out from the LSU University Health Sciences School of Medicine seven years ago. The three things we were aiming to develop with a non-opioid pain management drug were to avoid the toxicities of other currently available medicines like ibuprofen on the kidneys and stomach, and the liver toxicity of acetaminophen, or Tylenol, and obviously the abuse potential of opioids. It took about two and a half years to characterize our original library of compounds to determine which ones were working to reduce pain while also being safe.
How did you raise funds for the lengthy initial scientific work?
We received a small-business research grant from the NIH from 2020 to 2023, for $1.9 million. With that money we were able to do what the FDA requires to open an investigational new drug, or IND, application. These are significant milestones for a biotech company because then you can go into patients and start doing clinical trials. Then we raised $4 million from Ochsner Health, allowing us to begin phase one human trials in Miami, which showed our lead asset (SRP-001) was safe in humans, which we thought it would be based on our preclinical studies. That also showed robust PK, or pharmacokinetics, which is how it gets absorbed and distributed in the body, which is very important.
We got a second NIH grant late last year from the National Institute of Neurological Disorders and Stroke for $400,000 and we did another raise from Ochsner for $1.85 million that allowed us to continue the clinical development and what’s called the formulation development, which determines the most appropriate route to achieving effective drug delivery in patients.
What is the commercial potential of a breakthrough non-opioid pain drug?
You look at Vertex Pharmaceuticals, based in Boston. It’s a tremendous company with a market value of about $123 billion. They have a pain asset, Suzetrigine, that is set up like ours. When it announced the end of phase three trials its stock surged. [It is up more than 25% since the completion of third phase clinical trials was announced in April.] There have been estimates their pain drug could have a market space of $11.4 billion but there is tremendous variation. There is a tremendous need for these new drugs but the question is how are they going to be paid for when there are still cheap generics available. I think, in the end, when something is shown to be quite ethical they will be paid for but that is the discussion right now.
If your drug gets market approval a company like South Rampart Pharma would have different aims in bringing it to market than a company like Vertex?
So, they have sales forces, manufacturing capability. We’re working to develop this as far as we can. We have spoken to the major pharma that are in the pain space. They want to follow very closely to see what those phase two results are. Obviously, if we were the do a deal now it would have only so much value, whereas if you can partner after phase two it would have a much larger value.
You and your father have talked about supporting the development of a New Orleans bioscience community and what it would take to help foster that community here. Has your experience developing the pain drug indicated progress on that front?
We were trying to support everything that was available here. Nova Research Labs, one of the clinical research organizations, or CROs, here in New Orleans, helped us to look at what are called hERGs, to make sure that it is not going to cause a heart rhythm problem. That’s one of the many things the FDA asks you to check. It was good to be able to use a local firm for the many, costly tests we had run as part of our process.
Also, you got the National Institutes of Health’s “Helping to End Addiction Long-term, or HEAL, Trailblazer Award” earlier this year. Does something like that help in the city’s efforts to develop as a bioscience hub?
Yes, that and the fact that the FDA granted us “Fast Track” designation — as far as I know, we’re the only company in our state in history to get that designation. All of this is important because, for example, in June, I chaired a session on “next gen therapeutics” at the Bio International Conference in San Diego, with a program director from NIH, a business development director from Merck, an investment banker, a gene therapy founder. That helps recognize our leadership in the field, which then goes back to the city of New Orleans.