Entrepreneurship Tech Apr 06, 2016

The Answer to Pharmaceutical Cannabis May Be Olive Oil

You will often hear medical marijuana enthusiasts talk about the wonders of the endocannabinoid system: a series of receptors in the human body that regulate the human body’s activities, from the creation and recycling of cells to pain perception and recovery.  Though it is fundamental to human health, the endocannabinoid system was actually discovered only recently in the mid-1990’s by Dr. Raphael Mechoulam, who was studying THC, the main active ingredient in marijuana, at Hebrew University in Israel.   It’s this system that reacts to cannabinoids and endocannabinoids, which are the healing compounds that naturally occur not only in the human body, but also in cannabis.  In fact, there are over 60 cannabinoids found in marijuana, and there are varying levels of those cannabinoids of each of the more than one thousand strains that exist.  

As a result of cannabis’ complexity, Dr. Mechoulam and his team at Hebrew University have worked to isolate and synthesize a variety of molecules that act like the same cannabinoids found in marijuana.  This makes them easier to study, test, and quantify the effects.  Kalytera, a clinical stage pharmaceutical company, aims to take two of these molecules to the mass market by developing them as FDA-regulated drug therapies.  The company, which got its start in 2014 just outside of Los Angeles, California, will replicate some of the same benefits you might find in cannabis, but will engineer the molecules to treat specific ailments.  This means patients will one day be able to ingest individual cannabinoids without experiencing marijuana’s psychoactive side effects.

seth photo

Seth Yakatan, co-founder of Kalytera

Right now, the two molecules Kalytera is developing are KAL671, which is a candidate for treating osteoporosis and a rare genetic disorder called Prader-Willi Syndrome, and KAL436, which may be used to treat bone fractures and obesity.  Surprisingly, KAL671 is derived from olive oil.  The Mediterranean diet staple contains a molecule that is analogous to anandamide, which is a master regulator of the endocannabinoid system.  KAL436, on the other hand, is a synthetic analog to cannabidiol (CBD), a non-psychoactive cannabinoid found in cannabis.

Though Kalytera’s mission is to develop these synthetic compounds as drug therapies, co-founder Seth Yakatan does not deny that the marijuana plant as found in nature could be more effective in treating illness.  “I believe that the plant is extremely efficacious,” he said.  “The reason I decided to create Kalytera in the way that I did is because we know so little about the plant and about how it works and its mechanism of action and all of its constituent parts, that it’s really difficult [to use the plant] in a clinical setting.”  Kalytera is not founded on the principle that synthetic compounds are better than using natural marijuana, and does not reject “whole plant medicine” theory, which is the idea that ingesting the full plant has health benefits thanks to unique synergies between its cannabinoids. Rather, Yakatan believes that it will be easier to develop one individual molecule and test it for quantifiable results than it would be to try to capture and quantify all of the effects of the marijuana plants for the purposes of acquiring FDA approval and a pharmaceutical patent.

“I believe that the plant is extremely efficacious,” he said.  “The reason I decided to create Kalytera in the way that I did is because we know so little about the plant and about how it works and its mechanism of action and all of its constituent parts, that it’s really difficult [to use the plant] in a clinical setting.”

Yakatan expects that because of the approach they have taken, Kalytera’s two drugs will face little to no challenge from the FDA once they are fully developed.  However, the process could take quite a while: though development at Kalytera has been well underway for a little over a year, it typically takes at least seven years to bring a pharmaceutical drug to market.  If successful, KAL671 and KAL436 will likely be available sometime next decade as prescription drugs that you would purchase at a pharmacy.  In the meantime, Yakatan says that that one of his biggest challenges is the media attention that comes from Kalytera’s association with cannabis.  “I’m used to walking around and begging people for meetings,” he told me. “With this, we’re very out front.”