Botanical Pharmaceutical Co. Enters Psychedelic Space

Jaguar makes one of the two FDA approved Botanical Drugs

A few weeks ago, I read a press release about a company launching an entheogenic drug development project based on a library of natural products derived from Africa and South America.

One name on the Scientific Advisory Board stood out.

Wade Davis.

Davis is a prominent author and anthropologist who has studied indigenous cultures, medicines, and primitive ways of life, including psychedelic and entheogen use among South American tribes.

He's the kind of scientist who no longer has to publish drab academic papers or perish but rather books that get turned into movies and articles for places like Outside Magazine and National Geographic.

He might be considered a hero to a certain breed of nerds and will likely be the subject of an Indiana Jones-type film someday.

The company in question is Jaguar Health, and they are notable for reasons beyond Davis' involvement.

In April, I wrote:

"In 1984 the FDA started getting applications for new drugs that did not fit the classic synthetic, single active agent model that they were used to.

They started getting so many botanical applications that they created guidelines for applicants developing Botanical Drugs.

Most of the botanical drug candidates were for Cancer and derived from traditional uses like Chinese Medicine and Ayurveda.

Here's the problem:

The FDA doesn't approve many Botanical Drug applications:

“The United States FDA has received over 800 botanical investigational new drug applications (IND) and pre-IND meeting requests (PIND) in the years preceding 2018… Despite increasing global interest in the investigation of botanical mixtures as drug products, only two botanical new drug applications (NDA) have been approved in the U.S.: Veregen in 2006 and Fulyzaq (also known as Mytesi) in 2012. Given botanicals' chemical and biological complexity, efforts in characterizing their pharmacology, demonstrating therapeutic efficacy, and ensuring quality consistency remain scientific and regulatory challenges.”

Jaguar Health created Mytesi— one of only two Botanical drugs ever approved by the FDA, making Jaguar that rarest of breeds—a plant-based pharmaceutical company.

We've covered the topic of Botanical Drug Development a few times here.

Botanicals are products manufactured from naturally occurring starting materials without a single active ingredient but rather a mixture of collectively active compounds and have a horrendous track record of gaining FDA approval.

I feel that many psychedelic companies that started with plans of creating natural, plant-based, FDA drugs are hoping for policy change instead, and now here’s Jaguar entering the fray.

From the September 16th Press Release:

"Jaguar Health, Inc. (NASDAQ:JAGX) announced today the formation of a scientific strategy team (SST) to support the company's recently launched mental health Entheogen Therapeutics Initiative (ETI), which aims to discover and develop groundbreaking, novel, natural medicines derived from psychoactive plants..."

CEO Lisa Conte:

..we believe the same competencies and multi-disciplinary scientific strategy that led to the development of crofelemer will support collaborative efforts to discover and develop novel first-in-class prescription medicines derived from psychoactive plants. I am particularly excited to bring back so many members of the original SST that led to the discovery and development of Mytesi, our plant-based, FDA-approved drug product."

Jaguar, one of two developers to have slain the ultimate dragon of FDA approval of a botanical, is entering the psychedelic space.

So you're telling me there's a chance

Mytesi is approved to treat diarrhea caused by HIV medications and is derived from the Sangre Grado tree sap, a longstanding ingredient in indigenous medicine.

I know what you're thinking, "If they can do it, surely we can do it."

Here's the problem - it took them over 20 years.

From a 2011 Forbes article:

"Conte's saga began in 1989 while she was working as an analyst covering biotechnology companies for a venture capital firm in San Mateo, Calif.

During a vacation climbing Mount Kilimanjaro, she watched a fellow climber quell altitude sickness by ingesting a plant-based concoction he bought at a trailside pharmacy.

Inspired, but without any savings, Conte decided to launch Shaman Pharmaceuticals (Napo's precursor) to fashion prescription drugs from plants."

Since then, the company has been through three iterations. First, they were Shaman Pharmaceuticals, then Napo, and now Jaguar health.

They IPO'd at least twice, raised over $300 million, and appear to have had a challenging relationship with indigenous groups in the areas they harvest the tree sap.

It hasn't just been a long road but a bumpy one as well.

With the regulatory landscape as it is, Jaguar must be thinking that they are either positioned to get another plant-based product through the FDA gauntlet or can take advantage of anticipated changes in drug policy.

On Friday, they announced plans to develop Alstonine for the treatment of Schizophrenia:

"Jaguar Health... announced today that the company's recently launched mental health Entheogen Therapeutics Initiative (ETI), aimed at developing groundbreaking, novel and natural medicines derived from psychoactive plants, is targeting the plant-based compound alstonine for possible schizophrenia and psychoses indications...

Alstonine is a heteroyohimbine-type alkaloid that occurs naturally in a variety of plant species, including a species of West African plant contained in Jaguar's proprietary library of plants with medicinal properties..."

Schizophrenia is the condition that everyone else is staying away from; meanwhile, Jaguar is going after it.

It took 25 years to get the first one done, and if they're at it again, they must think they've got a pretty good shot.

Thanks for reading; see you on Wednesday with a roundup of the news.

Best,

Zach