Having started and successfully exited several life sciences companies in Canada, what drew your attention to Dr. Shackelford’s story as the next great opportunity?
I was contacted four years ago by someone in Israel who had spent some time with Alan Shackelford, a Harvard trained physician that had been using cannabinoid-based therapies to treat epilepsy in a manner that succeeded where traditional methods had failed. But he could only treat so many people in one day, so the question arose – how could he treat the millions of people in need globally? The answer Alan came up with was to develop cannabinoid-based therapies into prescription drugs that could be readily available to all that needed them. Alan, not being a businessperson, needed someone to turn an idea with purity of intention into a commercial success, and thus our marriage was born.
What does Dr. Shackelford’s database mean for your ongoing efforts to treat neurological conditions?
We have at our disposal an incredible database of over 25,000 patient interactions that Dr. Alan Shackelford has had over the last 14 years. This represents unique and insightful real-world experience for cannabinoid-based drug development. No pharma company to our knowledge has this kind of resource. In 2013 Alan made worldwide news after the successful treatment of a five-year-old girl who was suffering from nearly 300 seizures per week, and who had already tried 17 other potential treatments, unsuccessfully. Over time, using his intuitive nature, he noted that different patients would report similar benefits and he then proceeded to record details of patient symptoms that got better after treatment. Our R&D team is incredibly excited about the potential of Alan’s database and is motivated as him to help people.
Are you confident that the FDA will approve SP1707 for Phase 2 clinical trial?
I am as confident as anyone can be, but there are no guarantees. We have received feedback from the FDA on our Pre-IND (investigational new drug) meeting and are confident that we will meet the agency’s expectation for the full IND submission that will allow the Company to progress to our Phase 2 trial. Our confidence comes from the real-world experience of decades of patient treatment and years of data, backing our first indication. To support the development of our drug candidate, which we call SP1707, we have assembled a world-class R&D team that has collectively developed 43 FDA approved drugs, including six anti-epileptic medicines. Notably, our head of R&D previously oversaw the GSK Neurosciences Discovery Medicine Portfolio. Furthermore, our head of regulatory affairs held the same docket at Pfizer, and the chair of our Scientific Advisory Board was responsible for setting the standards for epilepsy for the FDA. Our team, which includes world renowned epileptologists, has reviewed the human data that is the foundation of our drug development program, and they are very excited.
What is the commercialization journey following approval and reach you expect the drug to have?
Unfortunately for people with epilepsy, there are still significant unmet needs that have yet to be adequately addressed.
Approximately one-third of the global 50 million people with epilepsy do not respond adequately to their medication and have uncontrolled seizure activity.
On top of those 50 million, the World Health Organization estimates that there are about 5 million new cases every year. Focusing on just our initial indication, our internal analysis shows this alone represents a market potential of $3 billion. Let me also add that the company has multiple additional potential indications in the database, including targets outside of neurology
Once approved by the FDA, we plan to introduce the drug to the market through traditional channels. As we progress through the regulatory process, we will start to educate doctors by familiarizing them with the clinical trial results to build the medical community’s trust. In addition, we have an equally motivated commercialization team in place in anticipation of the approval. Of note is a Board member who was the former global product Vice President for AstraZeneca, and a team member with extensive experience in commercialization of drugs.
What are the near-term priorities for Shackelford Pharma, particularly looking at financing goals?
Our commitment to investors is to generate a return, and so we intend to ultimately become a public company so they can enjoy liquidity in addition to providing a venue for additional financings. Our primary focus is on fundraising. Currently, we have raised approximately $10 million, mostly from individuals, and we are now seeking $30 million from institutional investors to support our company through our Phase 2 clinical trial and final formulation development. We plan to introduce the company to as many investors as possible, with the view of inviting them to become shareholders.
Longer term, we will continue to build company value for everyone involved, with the overarching mission of bringing life enhancing medicines to epilepsy and other therapeutic areas for those with unmet medical needs.
You have successfully brought to life several success stories in the life sciences industry – what type of excitement is Shackelford Pharma bringing by comparison?
There is so much satisfaction in seeing results in an industry that takes years, even decades, to get from idea to commercialization. It is always exciting, but what I feel now is not a traditional kind of excitement. The excitement of utilizing the real-world results that Dr Shackelford has enjoyed has attracted a world-class R&D team and Scientific Advisory Board to our company. You don’t see the calibre of people involved in this size of company often, if at all. The real-world results are also exciting! What we need to do now is to translate those results into clinical trial results, which excites our team.
It is quite exhilarating to be in a position to potentially help millions of people suffering with epilepsy, along with their families, who have been struggling with seizures. I am very proud of the team we have and to me, it is absolutely thrilling to have so many people supporting Dr. Shackelford’s vision.
