People have been using plants as medicine for thousands of years, all the way back to Neanderthal days by some accounts. Innovations such as synthetic chemistry have taken their turn in the spotlight, but with some 300,000 species of plants on Earth, scientists often look back to basics for new drug discoveries. It’s called different things in different regions – i.e. Chinese traditional medicine (TCM), “botanical drug” (U.S.), “natural product drug” (Korea), “herbal medicinal product” (Europe) – but, by whatever name, there is an accelerating trend towards plant-based medicine to tackle historically difficult diseases and conditions.
This trend is evidenced by BCC Research forecasting the global market for botanical and plant-derived drugs to grow from $29.4 billion in 2017 to around $39.6 billion by 2022.
Botanical drugs are entrenched in the mission statement of American BriVision (Holding) Corporation (OTCQB:ABVC). The California-based company leverages its deep connections in Asia Pacific to source promising drug candidates, subsequently moving them through the pipeline via relationships with leading medical centers in the U.S. to target areas of intense medical need.
Amongst its robust portfolio, American BriVision’s lead experimental drugs are ABV-1504 and ABV-1505, which are being evaluated in clinical trials for Major Depressive Disorder (MDD) and Adult Attention Deficit Hyperactivity Disorder (ADHD), respectively. Clinical trials have delivered impressive data so far, showing the drugs to be efficacious and safe.
Both drugs utilize the active ingredient PDC-1421, a product of the Polyhala tenuifolia plant. This plant, also called “Yuan Zhi,” has long been recognized for producing powerful compounds in its root system that have a litany of therapeutic effects. Taken by many as an over-the-counter herbal extract, it is believed to support neuroplasticity, promote brain health and improve some cognitive functions, amongst other things. Like many other extracts, most evidence has traditionally been anecdotal, with a dearth of clinical trials to support claims.
That is where ABVC is starting to shine by conducting those human trials to validate the clinical benefit and broad-spectrum potential of PDC-1421.
A Phase 2 clinical trial for MDD conducted in 2019 by Stanford University and five major medical centers in Taiwan hit its primary endpoints for efficacy and safety. Patients receiving ABV-1504 demonstrated a 13.2-point reduction in depression versus a 9.2-point drop for those in the placebo group.
Currently, American BriVision is preparing for an end-of-phase-2 meeting with the FDA to align with the agency regarding design and goals for a pivotal Phase 3 trial.
With more than 300 million people worldwide suffering from clinical depression – with many dependent on serotonin reuptake inhibitors like Prozac, Zoloft and Lexapro - the value of ABV-1504 should increase exponentially if Phase 3 trials can hit the mark.
Many anti-depressive drugs, including the household brands Prozac (fluoxetine) and Xanax (alprazolam), are known to have some potentially serious adverse side effects, not to mention the risk of addiction.
Data from the trials showed ABV-1504 performing more effectively in treating MDD than Prozac (fluoxetine), as measured by the Montgomery-Asberg Depression Rating Scale, with zero serious adverse effects. Better than a blockbuster like Prozac with no side effects? That has “company maker” potential.
Company maker needs to be reiterated here. Consider that Johnson & Johnson’s (NYSE:JNJ) ketamine-derived nasal spray esketamine (branded as Spravato™) was approved last year by the FDA in combination with other antidepressant medicines for patients with Treatment-Resistant Depression. Analysts are calling for Spravato to be a blockbuster and reach $2.4 billion in sales in 2024.
New drugs for depression are quite an anomaly. The last one approved by the FDA for the indication before Spravato was 36 years ago. In a similar lane, the FDA last year approved Sage Therapeutics’ (NASDAQ:SAGE) Zulresso™ injection for postpartum depression.
One last nugget to share on the potential of American BriVision. Historically, big pharma in North America didn’t show a great deal of interest in incorporating botanicals as part of drug development portfolios. However, that changed drastically during the past decade, as drug makers have turned some attention to active ingredients that frequently have a wider therapeutic index while carrying a better safety profile than small molecules and immunotherapies.
A couple of cases to this point include Sanofi (NYSE:SNY) acquiring BMP Sunstone in 2010 for $520 million and Bayer (OTC:BAYRY) buying Dihon Pharmaceuticals in 2014 for $586 million. With all of American BriVision’s products in its pipeline, and it’s strategy as a biotech incubator / accelerator, there is a growing body of evidence that the lead products have the potential to one day capture share in large markets, something that could attract the interest of a major biotech company.
Shifting focus elsewhere, American BriVision last month completed enrollment in part one of a Phase 2 trial of ABV-1505 for adult ADHD. A small, quick study at the University of California San Francisco, six patients will receive a low dose of ABV-1505 three times a day for 28 days, followed by a higher dose three times per day for another 28 days. Management will then look to add to the growing database on PDC-1421 with a larger part two portion of the trial with expanded sites in Taiwan.
Shares have been channeling around $2.90 for most of 2020 before suddenly jumping to a six-month high in the couple of weeks, touching $3.85 on July 27th. All this underscores that investors are starting to take notice of this still largely undiscovered biopharma stock.