Bright Minds Biosciences’ (Nasdaq:DRUG) NCEs to progress into clinical trials

A majority of psychedelics firms are here for one simple reason, to support innovative therapies for the largely unmet neurological needs of patients grieving from Depression, Bipolar disorder, Drug addiction, Suicidal ideation, PTSD, Schizophrenia, Anxiety & Eating disorders. However, others are more focused on building a portfolio of clinics for psychedelics-assisted therapy and have partnered with MAPS and other non-profits to run patient trials from their sites.

According to the World Health Organization (WHO), about 280 million people worldwide were affected with some form of depression in 2019. The onset of Covid in late 2019 has undoubtedly caused a further spike in patient numbers. With the existing drugs unable to make a meaningful impact, there’s a lot of hope that this new class of psychedelics- the naturally occurring and the second-gen compounds would change the way patients respond to treatment.

Drug discovery-

But, are psychedelics safe, patentable and what’s the probability of growth for these biotech firms?
The hallucinogenic effects of psychedelics alter an individual’s consciousness differently from other drugs to the extent that it represents a ‘new’ state of realisation to many people. From the ongoing studies, it’s clear that classic psychedelics cause hallucinations, which may or may not be pleasant. The other adverse effects could include nausea, sensory experiences, panic, paranoia, loss of appetite & bizarre behaviours. However, the biggest problem with classic psychedelics is their affinity to the serotonin 2B receptor, the leading cause of heart valve diseases.

Several biotechs using classic psychedelics have been granted patents, with some even receiving a ‘Breakthrough Therapy’ designation for their molecules. For instance, Compass Pathways has 10-granted patents, but the nature of the IPs are unclear. Naturally occurring psychedelics are not patentable, so a ‘product’ or a ‘new chemical entity’ patent is out of the question. At best, Compass & the other biotechs testing classic psychedelics as potential therapies could receive a ‘process or method of use’ patent, which may not be a solid IP acceptable to Big Pharma. Even if these firms intend to provide the therapies themselves or partner with other firms operating wellness clinics and therapeutic centres, the scope to expand is limited, especially with the kind of competition we’re already witnessing.

The case for Bright Minds Biosciences-

Unlike most biotechs developing drugs from naturally occurring psychedelics, Bright Minds is creating novel compounds that retain the therapeutic benefits of psychedelics while minimising side effects like heart valve diseases & hallucinations. We can draw parallels to the discovery of the anti-inflammatory drug ‘Aspirin’ in the 1800s, despite the existence of the naturally occurring pain reliever found in willow bark and used for centuries. The only probable difference is that we have prevailing drugs to treat depression and other neuro ailments. But these are effective only against mild-moderate cases and lead to severe side effects in some instances.
Bright Minds is creating a much-advanced version of the decades-old medicines to treat even severe neurological diseases. All this with a lower trip time and negligible side effects of the naturally occurring psychedelics and the first generation SSRIs.

The following chart highlights the progress of the various drugs undergoing research at Bright Minds Biosciences

Patents-

Bright Minds has two granted patents on variants of the psilocybin molecule - the second generation of refined psychedelics. The firm has also applied for additional patents, and these should be awarded later this year. The granted patents are held in Japan, US, Canada and Europe.

The key features include

• Validity of the licensed/granted patents upto 2036.
• Guarantees complete patent protection & refinement.
• Allows the firm to generate revenue premiums.

The granted patents can be modified for

• Faster metabolisation through the body.
• Decline in respiratory/cardiac issues/symptoms.
• Safer and efficient use with fewer side effects.
• Oral consumption.

Patient population-

Bright Minds is creating novel drugs that target the 5HT2A, 5HT2C receptors individually and in combination. The purpose is to offer targeted treatment for neuropsychiatric disorders, epilepsy and pain, which together account for a massive patient population globally.

The US patient population for the drug pipeline at Bright Minds Biosciences

Conclusion-

The drug pipeline at Bright Minds Biosciences aims to treat seven disorders by targeting the 5HT2A & 5HT2c receptors. With the treatment cost for each indication running into thousands of dollars/year/patient, the market potential based on the patient population & patent protection is significant if these drugs make it to the market.
In a recent interview with the Midas Letter, the CEO of Bright Minds Biosciences, Ian McDonald, was delighted with the rapid progress in drug discovery. According to him, Bright Minds is carrying out the largest and the most advanced psychedelic drug discovery program in the history of the world, with over 25 chemists working round the clock to develop completely novel psychedelics. He believes that outside of ergotamines (drugs like LSD), these are the best psychedelics that have ever been created.
A strong statement from the CEO, but Bright Minds has put together a very experienced team of drug developers, scientists and chemists in the industry. Their current focus and earlier achievements in developing new therapies and bringing them to the market clearly distinguishes them from the competition.