Joel Stanley, the founder and former CEO and chairman of Charlotte’s Web (TSX: CWEB) has entered the psychedelic space through a new company, Ajna BioSciences. Ajna, is a botanical drug development company focused on full-spectrum cannabidiol and natural psychedelic options for mental health and neurological disorders. The company’s mission is to improve lives by delivering botanical pharmaceutical solutions to the medical and research ecosystems.
Ajna seeks to make use of underutilized guidance from the FDA for the development of botanical drugs. According to the FDA, a botanical drug product consists of plant material such as algae, macroscopic fungi, or combinations thereof and can come in the form of a solution, powder, tablet, capsule, elixir, injection, or topical. Botanical drug products often consist of complex mixtures, lack a distinct active ingredient, and have substantial prior human use. To date, only two drugs have fulfilled this definition and are approved for marketing as prescription drugs: Veregen® (sinecatechins), an ointment made from green tea leaves that’s used for treating warts and Mytesi® (crofelemer) an antidiarrheal drug made from the sap of the Croton lechleri plant.
The US pharmacopeia contains many prescription drugs that are derived from botanical and other natural sources. However, the traditional approach to developing these drugs involves isolating the biologically active compound(s) from their natural source and eventually moving away from the source altogether. Biochemical or chemical techniques are then developed and eventually are used to synthesize the active compound(s) in a laboratory setting for a fraction of the cost. But this approach is often not suitable for botanical drugs that rely on many active compounds to produce their therapeutic effects. This symphony of often synergistic effects arising from multiple different compounds is sometimes called the “entourage effect” when referring to cannabis’ unique effects on human health.
Ajna has developed a library of proprietary cannabis and mushroom cultivars that produce a rich diversity of phytochemical concentrations and ratios. Ajna’s leading candidate is a full-spectrum cannabidiol drug that is progressing toward clinical trials which they hope will begin as early as 2023. The company is also prototyping candidates for an investigational new drug (IND) application based on psilocybin-containing mushroom species Psilocybe cubensis, Panaeolus cyanescens, and Psilocybe azurescens.
Ajna BioSciences is headquartered near Denver, Colorado in a 13,500 square foot DEA Schedule 1 manufacturing facility. This Schedule 1 license allows for the production of psilocybin containing mushrooms. The company has engaged experts from Harvard, NYU, Johns Hopkins, and the University at Buffalo to support their growth. Two UB Professors, Dr. Gene Morse, PharmD, FCCP, BCPS, and Jeff Lombado, PharmD, BCOP, serve the company in different capacities. Morse as a member of Ajna’s scientific advisory board and Lombardo as the vice president of pharmacology.
Charlotte’s Web, whose development lab was located in Buffalo, is the company responsible for igniting consumer interest in hemp-based CBD (cannabidiol) products.