Multiple sclerosis, or MS, is a degenerative neurological disorder that makes life gradually more difficult for patients. Loss of muscle control is common, a result of an overactive immune system attacking and degrading the protective myelin sheath around nerves and eventually rendering them useless. Current standard of care, based on immunosuppressants, is able to slow the effects and make life manageable for patients. But the damage still occurs and there is no cure.
FSD Pharma Inc. (NASDAQ: HUGE) (CSE: HUGE) is taking a very different approach to its potential treatment for MS. Rather than suppressing the immune response, FSD’s drug candidate LUCID-MS acts directly on the myelin sheath to prevent degradation. LUCID-MS is a new chemical entity that represents a radically different strategy. If the promising preclinical studies are to bear fruit, a well-rounded team of experts with varying skill sets will be required to advance the drug further through clinical trials and potentially to market. FSD Pharma has been assembling that team to capitalize on the eleven years of research and development already devoted to LUCID-MS. Let’s take a look at what the company has and where it’s going.
What FSD Pharma Has Now
In September 2021, FSD Pharma acquired Lucid Pyscheceuticals in a deal valued around $9 million. Lucid’s co-founder Dr. Lakshmi Kotra came along in the acquisition and is CEO of the wholly owned subsidiary. The team at Lucid Psycheceuticals is now leading the development of three of FSD’s drug candidates, Lucid-MS, Lucid-PSYCH and FSD-PEA. LUCID-MS, the lead compound at FSD for potential treatment of MS, was first discovered through research conducted at University Health Network, a conglomeration of institutions in Toronto that comprise Canada’s largest research hospital. From there, Lucid exclusively licensed the compound to spearhead further development.
One of the major activities at FSD in the past six months has been to bring visionary and talented leadership to spearhead the development of its growing pipeline of candidate molecules. The FSD team now has the experience and background to lead the development of Lucid-MS, as well as the other two candidates in its pipeline, through the clinical trials process.
Dr. Kotra is a Senior Scientist at Krembil Research Institute, University Health Network, and Professor of Medicinal Chemistry at the University of Toronto. He is an innovative and recognized researcher with a raft of publications and presentations under his belt. Dr. Kotra received several awards during his career in recognition of his contributions to drug discovery and commercialization efforts, including the Julia Levy Award in 2021 from the Society of Chemical Industry (SCI) Canada. Dr. Kotra’s focus is on drug development and commercialization, and he has contributed to the advancement of several drug candidates. His research and insight led to the founding of Lucid Psycheceuticals around its two main compounds, and he has co-founded two other companies based on separate discoveries.
Bringing a drug candidate through clinical trials takes much more than research, and FSD has been rounding out its team of experts with a variety of complementary hires and appointments. Kevin Cassidy, VP Quality Systems, has deep operational experience in the biotechnology industry with a focus on process and business development. He knows the ins and outs of establishing and running GMP manufacturing facilities and quality testing operations. He was instrumental in the approval of the world’s first adenovirus-vectored vaccine, for rabies, which was a key precursor to some of the current COVID-19 vaccines.
Dr. Andrzej Chruscinski recently joined the FSD team as Associate Vice President, Clinical Affairs, and is leading the company’s clinical trials programs. Dr. Chruscinski earned his MD and PhD at Stanford University prior to joining University Health Network. While there, he completed two clinical trials designed to improve the success of organ transplantation along with other major accomplishments. His experience in designing complex clinical trials in varying clinical settings is an asset to FSD’s clinical programs.
Ms. Joanne Speed, who came to FSD through the Lucid acquisition, is Senior Director, Drug Development and has over fifteen years of experience in the biotech industry. Ms. Speed also has experience with late-stage candidate development, including being a key contributor to the Chemistry Manufacturing, and Controls regulatory package for a new drug submission to U.S. FDA and Health Canada. Ms. Speed received her Honours Bachelor of Science in Biological Chemistry (University of Toronto), Certificate in Biotech Project Management from University of Washington and University of California and Clinical Research Associate Certificate from Michener Institute, Toronto, ON.
Ms. Ashwini Joshi also came to FSD through the Lucid acquisition. She is Director, Pharmaceutical Development with over 9 years of experience developing formulations on small molecules for global markets in mid to large generic and pharmaceutical companies. She worked in various drug developmental stages starting from product development at R&D to its successful scale-up and regulatory filings. Ms. Joshi received her Master’s in Pharmacy (Pharmaceutics) from NMIMS, Mumbai, India and a Post Graduate Diploma in QA & RA from Academy of Applied Pharmaceutical Sciences, Toronto, Canada.
Dr. Oksana Akhova came on board as Director, Licensing, Partnerships and IP. She has over two decades of experience in the commercialization of scientific assets, management of private-public partnerships, IP protection, and licensing agreements. She holds a PhD in oncology and an MBA with specialization in biotechnology management.
FSD is continuing its efforts to bring talented people to bolster its team to develop innovative therapeutics for the treatment of challenging diseases. Taken together, these additions represent many decades of real-world experience in everything that happens after a drug candidate is discovered. They join an extensive group of employees and advisors assembled to advance FSD’s discoveries into the clinic and beyond. From clinical trial structure and implementation to IP protection and business development, from quality systems and operations all the way through marketing and commercialization, the team at FSD Pharma has the bases covered to support its novel drug development program.
Where FSD Pharma is Headed
2022 is shaping up to be a very big year for FSD Pharma with several potential catalysts looming. Each of its three drug candidates is expected to advance. LUCID-MS is currently in preclinical, IND-enabling studies and is on track to potentially enter Phase I clinical trials in Q4 2022. LUCID-PSYCH, for the treatment of major depressive disorder, is at a similar stage of development and is anticipated to enter Phase I in Q4 2022 as well. FSD-PEA is already proven safe through its completed Phase I trial and is expected to enter Phase II very soon, in Q2 2022. FSD-PEA is an anti-inflammatory compound that could be applicable to a wide range of inflammatory diseases, and the company is currently evaluating which condition would make the most sense for its initial Phase II trial.
For a pharmaceutical company with three clinical development programs addressing major indications like MS, depression, and inflammation, FSD Pharma’s market cap of about $41 million is very small. Historically, the value created by public companies advancing drug candidates into clinical trials is well documented. Whether the company itself takes the candidate through approval to the market or licenses to/sells to/partners with a larger organization along the way, value is typically enhanced with each advancement.
FSD Pharma has assembled a talented team that appears able to shepherd the process, and 2022 is chock-full of potential developments for the company. Investors are encouraged to keep an eye on this intriguing pharmaceutical player.
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