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Psilocybin's Potentially Revolutionary Ability To Treat Depression Hinges On FDA Approval – AJNA BioSciences Is Standardizing Raw Materials To Meet Guidelines

By: News Direct

October 02, 2024 at 08:25 AM EDT

--News Direct--

By Anthony Termini, Benzinga

More than $4 million have already been raised from institutional and individual investors, and there are just a few days left to participate in AJNAâs crowdfunding offering.

Results of research conducted at Emory University, the University of Wisconsin-Madison and UC Berkeley estimate that more than five million Americans suffering from depression could benefit from psilocybin-assisted therapy. This first-of-its-kind peer-reviewed study is scheduled to be published in the scientific journal Psychedelics on September 24, 2024.

How Psilocybin Can Deliver Rapid And Sustained Antidepressant Effects

This latest research report is not the first to look into the use of psilocybin to treat depression. There is a body of research showing that it can potentially deliver quick and continuous antidepressant effects.

For example, results of randomized clinical trials have been published in the Journal of the American Medical Association and by the University of California San Francisco. In fact, psilocybin’s therapeutic properties had been researched as early as the 1950s by Swiss drugmaker Sandoz Group (OTC: SDZNY) as part of specific psychiatric studies.

A Pioneering Drug Development Company Focused On Botanical Therapies

All of this seems to support the work of AJNA BioSciences, based in Littleton, Colorado. The company could be strategically poised to lead and create value in this emerging category of pharmaceuticals. AJNA is currently developing a full-spectrum psilocybin “novel antidepressant.”

AJNA believes that a standardized botanical medicine made from psilocybin will be in high demand. It reports that in 2020, doctors prescribed nearly $19 billion worth of drugs to treat depression. Researchers have estimated that the market for psychedelic drugs will grow annually by more than 12% through at least 2027. AJNA believes it can capture a high single-digit percentage of that market.

What is significant about AJNA’s drug development work is that it is standardizing botanical materials to meet strict FDA guidelines. AJNA reports that it is the first biotech company working with botanicals under a DEA Schedule-1 license.

AJNA is developing a daily-use anti-depression treatment through what it intends to be a fully characterized and FDA-approved formulation. AJNA has advanced the development of two prescription drug candidates: its CBD-based Autism Spectrum Disorder drug is anticipating a phase 2 trial in late 2024, and its psilocybin-based antidepressant drug has a phase 1 trial scheduled for early 2025.

The company’s research team, led by scientists from Harvard, Johns Hopkins and New York University, is conducting clinical trials in the same manner as large drug manufacturers. However, AJNA is working to transform the pharmaceutical industry by pioneering a new regulatory pathway to produce drugs from plants.

Why AJNA Is Focused On FDA Approvals

Authors of the research to be published by Emory University, the University of Wisconsin-Madison and UC Berkeley say that their “projections are highly contingent on…precise FDA approval parameters.” In other words, how broadly or narrowly the FDA defines this new class of drugs.

AJNA seems to have anticipated some of this. It reports that it has distinguished itself as one of the leaders in the evolving field of botanical drug development and has paid strict attention to how the FDA is defining the pathways for botanical drugs to get approved.

Joel Stanley, AJNA’s CEO, says that FDA approval is a critical component of bringing new drugs to market. Federal law requires that a manufacturer show that the drugs they produce are safe and effective.

Stanley also notes that without the FDA’s stamp of approval, a drug is unlikely to be considered for reimbursement by health insurance carriers. For botanical drugs to be an accepted component of a physician’s and patient’s routine treatment options, they must be approved by the FDA.

AJNA is committed to producing natural botanical drugs that have undergone rigorous laboratory and clinical scrutiny to demonstrate that they deliver “nature, backed by science.”

AJNA is currently raising capital in a crowdfunding round through Wefunder. Stanley says that “by investing in AJNA, you’re helping to change the healthcare paradigm to include optionality that none of us have ever had.”

With less than a week before the current financing/investment opportunity closes, interested investors can find more information on the Wefunder website.

Featured photo by Monika Schröder on Pixabay.

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