“The best way to attract investment is with serious science and well-validated clinical mechanisms of action. An asset in the clinic with a well-described mechanism of action for how it works and peer-reviewed science, including NIH funding, helps with the validity.”
Can you give an overview of South Rampart Pharma and present SRP-001?
South Rampart Pharma is a clinical-stage, phase 1 life science company developing a best-in-class new chemical entity (NCE), SRP-001, a non-opioid small molecule analogous to acetaminophen or paracetamol. The significant differentiator is that it does not have the liver toxicity of acetaminophen /paracetamol/Tylenol or the kidney toxicity of NSAIDs like ibuprofen. We have taken this venture from synthesis and discovery to a composition of matter patent issued in October 2022 by the USPTO. It is currently being nationalized throughout different markets in the world. South Rampart Pharma has the exclusive rights to develop and commercialize this technology. We have an active NIH grant of US$1.9M, administered through the NIH's National Institute of Neurological Disorders and Stroke (NINDS), which will help support the development of this drug candidate. The grant is an STTR “Fast Track” funded based on the heavy scientific basis for how the drug works in the brain to reduce pain and how it is differentiated from acetaminophen/paracetamol/Tylenol for the lack of liver toxicity.
Can you elaborate on SRP-001’s role in pain relief and the issue you identified that prompted this candidate’s development?
There is a massive void in the life sciences for new pain medications, as there has been no innovation in the pain space since the 1960s. Outside of opioids that have abuse potential, acetaminophen, which causes liver toxicity, and NSAID, which causes kidney toxicity and gastrointestinal damage (ulceration), there are no other options for pain. There are a few medicines for neuropathic pain, such as Lyrica and Neurontin. Still, my experience as a clinician is that they do not work very well, and many patients do not tolerate well their CNS sensory and neural depressive effects. Hence, there is a tremendous need for new, simple, safer, and clinically proven innovations in the pain space.
Our SRP-001 candidate works in the brain to reduce pain similarly to acetaminophen by producing AM404 without toxicity levels. The difficulty with pain is that it is subjective. Therefore, we have teamed with one of the world's experts in pain clinical trial studies who uses an acute pain model that evaluates a treatment's safety and efficacy in subjects undergoing a 3rd molar (wisdom tooth) extraction. This model has hard endpoints where one can get the curves to separate, and our strategy is to use this type of model and design in the phase two trial to show proof of concept efficacy in the pain space and to attract the investment to be able to move on to more extensive trials.
How do you intend to leverage the NIH Fast Track STTR commercialization grant?
The grant was funded in late 2020 and tremendously helped facilitate the IND-enabling studies and the non-clinical studies we have done to further characterize the consistent pain relief in four different animal models. This allowed our IND to open with the FDA and entry of SRP-001 into the clinic. Moreover, being an STTR PI, the NIH offers a tremendous resource through its Small Business Innovation office, giving us access to independent market analysis. We are working on a CRP (commercialization readiness program) in the business development grant in April 2023. Because of this active STTR fast track, the NIH has other resources for possible support for clinical development.
What are the main challenges and opportunities for clinical-stage companies in the US in 2023?
It is challenging for clinical-stage companies to find funding and the proper support to advance their pipeline. When one is fortunate to raise financing as we have, I believe it is essential to utilize that capital intelligently and highly efficiently to move the needle forward regarding clinical development. Getting to a developmental situation where you can describe the science and have a phase 2 trial well delineated is necessary. That will give the finance community and strategic investors more confidence that the clinic will have clinical efficacy. Hence, put all the money into the R &D and avoid overhead whenever possible.
Finally, I do think, in the end, the best way to attract investment is with serious science and well-validated clinical mechanisms of action. An asset in the clinic with a well-described mechanism of action for how it works and peer-reviewed science, including NIH funding, helps with the validity. Ultimately, the proof is in clinical data. Reproducible safety data, good pharmacokinetics from a Phase 1 trial, and the description of a Phase 2 trial with hard endpoints that will hopefully separate the placebo from the drug candidate being tested will drive interest.
What are the trends likely to shape the pain relief field in 2023?
I am optimistic that the BIO report on Pain Innovation released in February 2023 will lead to new momentum to get eyes and interest into the dire pain relief space. For the finance world, there is an excellent opportunity in this space due to the large void, and with all that is happening in the life sciences and biotech space, I suspect there will be an uptick in support in the field of pain relief.