Psychedelic industry making rapid inroads in treating neural disorders

Bright Minds Biosciences' (CSE:DRUG) BED and OUD candidates show robust efficacy in pre-clinical trials

In a bid to enhance neuropsychiatric treatment, US lawmakers across all the states are moving ahead to decriminalise psychedelics, such as plants and fungi, for therapeutic use. While lawmakers in Connecticut, Florida, California, New York, Virginia, Missouri, Hawaii and others are working on drug reform policy bills, Oregon has taken the lead by becoming the first state in the US to legalise psilocybin last year. Elsewhere, the Netherlands, Brazil, Jamaica, Peru and Portugal are a few psychedelic-friendly countries where one can easily acquire and consume magic truffles, mushrooms or Ayahuasca. In countries like Canada and the United Kingdom, the UN's Psychotropic Act 1971 continues to hold but vary in its implementation.

As countries gradually open up to the idea of meeting this vast unmet need following the ban in the 1970s, scientists and therapists have made significant progress in their quest to treat a range of psychiatric conditions such as depression, addiction, post-traumatic stress disorder and Alzheimer's.

The first-generation psychedelic drugs comprising Psilocybin, MDMA, LSD, or DMT proved effective in the past but failed to identify with some of the other mass-produced drugs by pharmaceutical firms.

For the drugs to find wide acceptance by the broader population and inspire traditional pharma giants to fund the research, there is an urgent need to innovate. These include addressing the daily drug usage by reducing them to periodic therapy, decreasing the trip time to reset the brain function, fixing issues related to severe side-effects and the option to take the drugs at home with remote monitoring. This is where Bright Minds Biosciences aims to play a critical role. The biotech firm has seven compounds in the pipeline to address various neurological conditions - three in early and four in late-stage pre-clinical trials. The drugs aim to cure disorders associated with the Dravet syndrome, Opioid use disorder, Binge eating disorder, Alzheimer's disease psychosis, PTSD, Depression, and Undisclosed Chronic Pain Disorder

Illustration of the mechanism, treatment and the current phase of the trials

Source: Bright Minds Bio website

Earlier this month, Bright Minds announced positive data from its late-stage pre-clinical trials to treat Binge Eating Disorder (BED) and Opioid Use Disorder (OUD). In the tests carried out at the Center for Addiction Research, the University of Texas Medical Branch, BMB's proprietary 5-HT2c agonists showed early positive results in rodent models. The BMB drug produced identical results to lorcaserin by suppressing food intake, especially high-calorie palatable foods. Higher doses resulted in a drop in binge eating by over 50%, followed by significant body weight loss with no noticeable side-effects during the 24-hour evaluation period.

WATCH the webinar where Dr Revathi Shreeniwas- CFO of Bright Minds Biosciences and Dr Kathryn Cunningham from the centre for addiction research- University of Texas Medical Branch share the data from the rodent model.

In another study, BMB's proprietary 5-HT2c candidate showed robust efficacy by suppressing fentanyl intake by more than 50% in rodents. The opioid self-administration model to investigate the neurobiology to study drug addiction in rodents is considered the 'Gold Standard' as the drug's ability to suppress fentanyl intake could reduce opioid use in humans. Dr Kathryn A Cunningham, the lead researcher from the Center for Addiction Research, the University of Texas Medical Branch, states that BMB's approach aims to reduce craving and promotes abstinence in patients suffering from this disorder.

WATCH the webinar of Dr Revathi Shreeniwas- CFO of Bright Minds Biosciences and Dr Kathryn Cunningham from the Centre for Addiction Research- University of Texas Medical Branch, where they share the data from the rodent model.

In the current context, drug overdose mortality has increased significantly in the US during the COVID-19 period to record the most significant overdoses in 2020. Based on 'The Lancet' report, as of July 2020, deaths from drug overdoses in the US rose by 13% year-on-year, with opioids contributing to more than two-thirds of the total deaths. Some of the reasons include increased stress, reduced access to life-saving treatment during the pandemic, lack of recovery support services and isolation.

Even typically, the World Health Organization believes that only about 10% of patients receive treatment, increasing their overdose risk. So, if successful, BMB's proprietary treatment for Opioid Use Disorder would also effectively reduce craving in patients addicted to tobacco-related products- the leading cause of preventable death and disability in the US.

Source: CDC.GOV

So, what is the market size to treat these various unmet disorders? According to Ian McDonald, the CEO of Bright Minds Biosciences, based on the US patient population and the existing treatment cost, the market potential is substantial. Among the neuropsychiatry disorders, the current annual treatment cost of generic drugs for Major Depressive Disorder (MDD) and Post Traumatic Stress Disorder (PTSD) runs into hundreds of billions of dollars.

Psychiatric market size for generic drugs in the US

Source: Stifel Healthcare Conference Presentation- March 2021

Bright Minds Biosciences is currently conducting pre-clinical trials on its innovative range of psychiatric compounds, and it could be a few years before they hit the markets. There are a few other biotech firms that are ahead in terms of their research. That said, BMB has an array of compounds that very few competitors can match, and the leadership team comprising scientists, medical practitioners, and drug makers are unmatchable in the industry.
As the competition heats up, Bright Minds is one of the leading candidates developing the next-gen psychedelic and non-psychedelic serotonin drugs with the added advantage of fully-granted patents for 5-HT2C and 5-HT2C/A

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