AJNA BioSciences' Strategy For Market Leadership In Botanical Drug Development With Magic Mushrooms And Cannabis

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Consumers are increasingly demanding natural health solutions, with recent surveys demonstrating that a majority of consumers believe products with natural ingredients are healthier and that botanical supplements are effective. Many people believe that "food should be medicine." Littleton, Colorado-based AJNA Biosciences says it is aiming to build a bridge "between what people want, and physician advocacy they can trust."

AJNA’s Pharmaceuticals Come From Nature Backed By Science

AJNA is focused on developing a new class of drugs derived from botanicals. The company is exploring plant and fungi species with therapeutic compounds that address specific conditions.

"The future of medicine is actually millions of years old," says Joel Stanley, CEO of AJNA. 

This ethos is guiding AJNA's development of two drug candidates focused on treating conditions that it estimates today affect more than 80 million people. The company's research team, led by scientists from Harvard, Johns Hopkins and New York University, are working on botanical drugs to treat or support people with Autism Spectrum Disorder and Generalized Anxiety Disorder.

Today, there is no FDA-approved natural remedy for either of these conditions, reports AJNA. They can both be treated with synthetic compounds engineered by big pharmaceutical companies, but those drugs can come with a number of unpleasant side effects.

AJNA distinguishes itself by participating in the evolving field of botanical drug development and is pioneering a new regulatory pathway to produce drugs from plant medicine that are ultimately approved by the U.S. Food and Drug Administration (FDA).

AJNA has advanced the development of two prescription drug candidates by standardizing botanical raw materials to meet strict FDA guidelines. The first drug candidate, CBD for Autism Spectrum Disorder (ASD), is preparing to enter phase 2 clinical trials with an upcoming Investigational New Drug (IND) filing, while the second candidate, Psilocybin for Generalized Anxiety Disorder (GAD), is approaching phase 1.

The two drugs in development are a full-spectrum cannabis-derived drug and a psilocybin-based antidepressant. AJNA says it will look to expand indications for these products beyond autism and anxiety to also include post-traumatic stress disorder, various sleep disorders, attention-deficit/hyperactivity disorder and chronic pain.

A Holistic Approach Based On Ethics And Sustainability

AJNA believes it is tapping into rising consumer demand for holistic treatment options that include natural remedies. The company says that demand has never been higher. As part of the company's ethos, it is committed to sustainable methods in its research and development processes. It is also committed to reducing its ecological footprint.

AJNA follows Stanley’s previous venture, a company he founded with his brothers called Charlotte's Web Holdings CWBHF. It started out as a mission not a company, giving away an extract to those who could benefit, then gained public recognition after the CBD oil was being used to treat seizures in 5-year-old Charlotte Figi. 

The company prioritizes minimizing the use of unnecessary and potentially harmful chemicals. AJNA’s psilocybin drug is processed using only the water from the fungi itself, without any added agents or artificial chemicals. If this drug gains FDA approval, it could be one of the few organic options available on the market. Additionally, the company’s commitment to environmental sustainability results in a largely organic waste stream, which is repurposed as compost and used as a soil amendment throughout the Denver area.

AJNA Could Be Poised To Benefit From Significant Shifts In Perception

The demand for psychedelic-assisted therapy is increasing at a time when the FDA is defining new drug development pathways for botanical drugs to get approved. This is helping AJNA build a bridge between what people want and the physician advocacy necessary to gain wider public trust.

The company's Chief Medical Advisor, Orrin Devinsky, is one of the first clinicians to research cannabinoids. His work as principal investigator led to the development of Epidiolex, the only FDA-approved cannabis-derived drug currently on the market.

"It is important for us to provide a [botanical] option that has clinical science behind it, so doctors can get behind it, so insurance can cover it for people in the future," said Stanley about AJNA's research and development and pending clinical trials.

AJNA also gains an advantage from unique intellectual property regulations that protect botanical drugs. Plant variety patents provide 20 years of protection, significantly longer than the five to seven years typically granted to synthetic drug compounds.

Big Pharma May Look To Botanicals For Future Growth

AJNA believes that major pharmaceutical and biotechnology companies will increasingly recognize the therapeutic and commercial potential of botanical drugs. Cannabinoids and psychedelics could be part of future opportunities for large players to acquire or merge with smaller botanical drug companies.

This is part of an established playbook in the biotech industry. A small company's successful drug development platform creates potential liquidity for investors. This may include the acquisition of a single drug candidate or the entire company. In many cases, these acquisitions take place before the target company begins to generate revenue.

In AJNA's case, the company is working with Wefunder to help it raise capital. Wefunder is a public benefit corporation with a goal to "fix capitalism" in addition to helping companies create shareholder value.

More information is available on the Wefunder website.

Featured photo courtesy of AJNA BioSciences.

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