The psychedelic revolution, albeit not the first, is indeed in full swing. Though the results will not be felt for a few years, but academic institutions like Johns Hopkins and Yale, have established departments to study psychedelic materials. Compass Pathways, a company founded to treat problems like depression using compounds found in hallucinogenic mushrooms, is being traded on the Nasdaq at a value of nearly $1.4 billion.
This revolution is not bypassing Israel; it has drawn a number of serial entrepreneurs, some of them with background in cannabis. “Compass Pathways has essentially written a treatment protocol for treatment-resistant depression; the patient goes to psychiatrists or psychologists who were trained by them, and after a few preparatory sessions, they undergo treatment with consciousness-altering mushrooms accompanied by the therapist,” explains Dr. Kobi Buxdorf, a biotech entrepreneur.
The U.S. Federal Drug Administration recognized these treatments, pushing the industry forward. It permitted the company to submit a fast-track request for approval, Buxdorf says. Since then, many companies have been launched that are trying to treat depression, PTSD, and phobias using psilocybin, a psychoactive component found in mushrooms from the Psilocybe family, which are known to be hallucinogenic.
Among the companies that Buxdorf has founded is CannaDorf, a biotechnology company that develops tech for growing and enhancing cannabis plants. He is also one of the founders of Biomilk, which develops technology to produce cultured milk in a laboratory. Around 18 months ago, Buxdorf joined up with two other entrepreneurs with a wealth of experience – Itay Hecht, who comes from the cannabis industry, and Dr. Asher Holzer, the founder of UroGen, a Nasdaq-traded company that develops treatments for cancers and urologic diseases.
The three of them launched PsyRX, whose goal is to produce consciousness-altering components that will meet pharmaceutical regulations – essentially, biological molecules. “The regulator doesn’t do so well with biological molecules and prefers to work with synthetic molecules. The technology we’re developing takes the biological world and adjusts it to the standard of the pharmaceutical industry,” says Hecht, who serves as the company’s CEO.
The company works with two consciousness-altering molecules, psilocybin and ibogaine, the latter of which comes from the African iboga shrub. “For decades, ibogaine has served as a substance to wean people from addictions, even with one-time use,” says Hecht. “It’s a bit of a problematic substance, and has a terrible user experience. People don’t take iboga and go to parties, or to the beach to be inspired, but it has enormous medical advantages.”
While the three mapped out a plan that would be effective and feasible – at least in theory – they brainstormed and consulted with psychedelic experts around the world. They finally decided to work on two fronts: The first is to produce raw material for the pharmaceutical industry made from psilocybin. This is a particularly complex process due to the industry and regulators’ demand for high uniformity, which is easier to achieve synthetically.
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“We are using technologies that probably no other company uses to grow the fungi,” Buxdorf explains. PsyRX is working with the Hebrew University’s Faculty of Agriculture, Food and Environment in Rehovot. There, under the direction of Dr. Maggie Levy, the company funded an experiment in which the psilocybin fungus is grown in what is known as a bioreactor – a facility designed for biological activity.
This technology allows them to control the fungi's growing conditions, so that the material will always meet the required standards. Buxdorf explains that it also lets them grow the fine film of threads that the mushroom sprouts from rather than the entire mushroom, and cause it to produce psilocybin. "This way, we shorten the process, make it less expensive, and reach a high level of uniformity.”
The company’s second project, the one using iboga root, is even more ambitious. The iboga root is also expected to be processed in Levy’s bioreactor in Rehovot. In this case, however, the company isn’t seeking to produce raw material for drug companies to use, but to improve an existing antidepressant and anxiety drug.
The idea, which is being patented, is to combine ibogaine with a drug from the selective serotonin reuptake inhibitors family (SSRIs) like Prozac or Lexapro. This would help reduce the side effects of existing drugs, like reduced sex drive and sleep and appetite changes, and to significantly reduce the time it takes until the drug starts to work. Generally, SSRIs need to be taken between three to six weeks until they start working, while with ibogaine, researchers expect the patient to feel the effects in less than 72 hours.
Hecht says that the company wanted to take an out-of-the-box approach rather than get into the clinical world: "We preferred to enter the field through prescription drugs. We have a reasonable basis to believe that the combination of antidepressants and ibogaine can be very effective.” He also notes that this is not a wholly new concept: a subsidiary of Novartis produced an ibogaine-based antidepressant from the 1930s to the late 1970s.
At a later stage, PsyRX plans to speak to the major pharmaceutical companies, after they decide which drug they want to work with. As far as the FDA is concerned, the approval process will be relatively simple because they will be working with an existing drug, compared to the labyrinthine process usually required of drugs that contain plant components.
The company hopes to begin animal testing in the coming weeks. At the same time, they recruited consultants for regulations and the active ingredients they are working with in order to launch the approval process in about a year. To date, the company has raised 6 million shekels ($1.87 million) from angel investors, which is being used to fund the research at the agriculture faculty in Rehovot and to begin the regulatory process. The next step will be a public offering via an IPO on the Tel Aviv Stock Exchange or in Canada.