The Central Nervous System (CNS) comprises the brain, spinal cord, and nerves and is the network through which the brain controls and communicates with every part of the body. The brain doesn’t just give us the ability to think, it allows us to function.

The CNS is an incredibly complex system that generally works well and allows humans to operate on a conscious and subconscious level. However, it can, and frequently does, go wrong. Unfortunately, when a problem occurs, it can have a severely debilitating impact on individuals and can, in some cases, lead to death.

The numbers affected by neurological disorders are significant, with around one in six people – over a billion individuals – suffering from CNS-related issues. These include Alzheimer’s, multiple sclerosis (MS), migraines, epilepsy, and strokes. Globally, it is the leading cause of disability and the second leading cause of death after heart disease.

Brain and neurological problems are rising

According to a study of 195 countries by the Global Burden of Disorders Study Group, neurological disorders increased 7.4% worldwide between 1990 and 2015. However, the study was broad, with some conditions rising faster than others.

For example, in the US alone, Alzheimer’s is expected to rise 22% by 2025. Another study found that the number of those with MS has increased in every world region since 2013.

One thing driving the rising overall number of neurological problems is the addition of conditions that were previously classified differently. For example, strokes were seen as a cardiovascular issue but have recently been reclassified as a neurological disease by the WHO. Interestingly, studies have also shown a link between MS and a higher risk of having a stroke.

Furthermore, research using MRI scans has discovered structural and functional changes in the brains of depression sufferers that are similar to several neurological disorders such as strokes, Alzheimer’s, and Parkinson’s.

Smaller biotech firms are developing multiple treatments

Although many of these conditions appear linked, they are usually treated separately. However, advances in science and technology are now making it possible for smaller biotech firms to develop multiple treatments.

A great example of this is FSD Pharma, which is currently developing three pharmaceutical products that target different neurological issues. Co-founder and interim CEO of FSD Pharma, Anthony Durkacz, explains, “We have three candidates, with one having the potential to revolutionize the way central nervous system diseases are going to be supported.”

“Our leading product is Lucid-MS, which is a treatment for multiple sclerosis. It is in the pre-clinical trial phase, and we are anticipating FDA approved in-human phase 1 trials in the last quarter of this year. The results have been excellent in pre-clinical trials and animal models. Lucid-MS demonstrated it could prevent and reverse myelin degradation, the leading cause of MS and other neurodegenerative disorders. We expect Investigational New Drug (IND) status in late 2022.”

Durkacz adds, “We also have Lucid-Psych, which is designed to provide relief to the millions of people suffering from Major Depressive Disorder. It is also expected to be in phase 1 clinical trials later this year. Finally, we have FSD-201, a micro-PEA compound to treat a range of inflammatory conditions that impressed for safety and tolerability in phase 1 trials and is heading into phase 2 trials in the coming months. These products are just the start.”

Co-founder and President Zeeshan Saeed says, “We have been fortunate to assemble an incredibly experienced team led by the renowned Dr Lakshmi P. Kotra, a recipient of the Julia Levy Award . In fact, our team has two Julia Levy Award recipients – and there have only been eight awarded in the 17-year history of the award. We also have half a dozen PhDs and two MDs working full-time on pipeline development.”

“This gives us a considerable advantage, but it has still been a lot of work. For example, Lucid-MS has taken 11 years of research and development – but we now have the ability to help millions of people suffering from various neurological conditions. By developing multiple compounds, we hope to achieve our ultimate goal - Total Brain Health.”

Exciting time to look at biotech as a biotech boom may be on the horizon

FSD Pharma’s success has not gone unnoticed by investors, and the company was able to go public in 2018. With three potentially ground-breaking compounds in development, shares in the company have proved attractive, and investors have been keen to get involved. This has left a healthy-looking balance sheet, with over US$40 million in funding and no debt.

Durkacz says, “The current market for MS treatment is around US$23 billion. That figure is rising as the disorder is unfortunately growing. Our funding and share of the market will allow us to develop products that can actually reverse the condition without suppressing the immune system. Developing these compounds takes money, time, and research, but the result will genuinely change the lives of millions.”

Saeed adds, “This is a very exciting time to be in biopharmaceuticals. With our experienced team and recent technological advances, we are on the verge of developing treatments that weren’t previously possible.”

Breakthroughs and new technologies are resulting in a boom in the biopharmaceutical sector. Developments have made it possible for biotech firms like FSD Pharma to develop multiple life-changing compounds at the same time. Consequently, the industry is growing rapidly, with total brain health within reach. The result will be transformative for millions of people.

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