PSYRX's Innovative Next-generation Plant Based Solution for Depression

Depression is an epidemic of our times, according to Itay Hecht, cofounder and business development manager of PsyRx, the Rehovot-based company that is developing natural pharmaceutical-grade psychedelics for a new generation of mental health therapeutics.

"US studies show that one in every four people treated for depression receives some kind of additional treatment when pharmaceutical solutions are insufficient or take too long to work," he says. "Not only are existing antidepressants of limited efficacy, their side effects are often very problematic — from weight gain to sleep problems to lowered libido. A large proportion of patients with depression, as many as 35 to 40 percent, don't respond to common SSRI [selective serotonin reuptake inhibitors] treatment, and improve only partially or not at all.

PsyRx was established in 2020, and last year, Prof. Itamar Grotto was appointed executive chair of its board of directors. His is a well-known face in Israel, having appeared regularly on TV during the COVID-19 outbreak. An expert and researcher in epidemiology and public health, Prof. Grotto is former deputy CEO and director of public health services for Israel's Health Ministry and a former member of the World Health Organization's executive committee. He is teamed in PsyRx with Nobel Chemistry laureate, Prof. Aaron Ciechanover, who serves on PsyRx's advisory committee, and company CEO Yoav Elishoov, formerly CEO of Tarima Pharmaceuticals Ltd. and founder and manager of Novartis Oncology in Israel and Eastern Europe. Together, the three are ushering PsyRx along important new paths to treating depression and other mental health problems.

Ibogaine, a mind-expanding substance derived from the root of the Tabernanthe Iboga plant, is one. PsyRx cites research which shows that ibogaine and noribogaine, which it manufactures, are extremely effectively in detoxing from addictive substances such as heroin, cocaine, morphine, methamphetamine, nicotine and alcohol — so much so that the US Food & Drug Administration has approved a clinical study of ibogaine in opiate withdrawal. Studies also indicate that ibogaine and noribogaine impact positively on psychological symptoms related to depression and post-trauma.

Combining the new with the approved The innovative medication which PsyRx is developing combines ibogaine with an approved SSRI anti-depressant, explains Prof. Grotto. "The ability of the ibogaine molecule to combat depression is recognized. Based on global studies, we expect that combining it with an existing antidepressant will impact positively within days, in contrast to existing antidepressants, which take several weeks to work — and thus becomes critical in disease development. We also believe that an ibogaine-based drug may significantly reduce negative side effects." "In tandem with creating this new medication, we're developing innovative ways of producing rare costly ibogaine molecules," says CEO Yoav Elishoov. "We're currently using them in pre-clinical trials, and later they'll go into the combination drug we're creating, as well as into other medications based on active psychoactive substances in development in the pharmaceutical industry. We expect this to become a significant source of income for PsyRx." The iboga plant is native to West Africa and micro-doses of its psychedelic derivative, ibogaine, were historically given to tribal warriors to bolster their courage. Ibogaine, notes Elishoov, is not new to pharma. It was registered in France as an antidepressant and stimulant, but its excessive use among athletes led to its banning and labeling as a dangerous drug..

"Our approach with ibogaine is unique," says Elishoov. "It's based on micro-dosing, as among the warriors, not on the 800 mg dose which triggers a major 'trip.' Combining micro-doses of ibogaine with existing SSRI drugs is expected to improve treatment of depression and substantially reduce its side effects." A significant advantage, according to Hecht, is that SSRI medications are already approved for treating depression. "This gives us regulatory advantage, an accelerated regulatory approval process," he says. "All we need show is that a drug which combines ibogaine with accepted medications is safe." Prof. Grotto adds: "There's enough known about ibogaine to ensure safe dosage."

With Health Ministry approval and a collaboration agreement with the Hebrew University's Robert H. Smith Faculty of Agriculture, Food & Environment in Rehovot, PsyRx has begun pre-clinical research and is planning future clinical trials. It has also has applied for patents for its combined ibogaine/antidepressant medication in several countries — one has already been granted by South Africa — bestowing significant competitive advantage.

Psilocybin 'magic' mushrooms The company is also investigating the therapeutic potential of another psychoactive substance — psilocybin, sourced mainly from hallucinogenic (so-called, magic) mushrooms. Its positive effect on depression, anxiety and addiction has been demonstrated, and it has been proposed as a treatment for obesity, PTSD and more. Collaborating here, too, with the Smith Faculty of Agriculture as well as with the University of Athens, PsyRx bioreactor technology is enabling production of psilocybin from these mushrooms at Active Pharmaceutical Ingredient (API) level, and it is currently growing tissue cultures.

Series C Financing A Series C financing round for PsyRx is now being conducted through the online equity-based crowd-investing platform ExitValley, with millions of shekels raised from private investor groups in the two previous rounds. One major investor is TrippyVC, the decentralized psychedelic therapy impact fund governed by a limited series of NFTs, whose founders include Bob Marley's son Rowan and NBA All-Star Amar'e Stoudemire. According to Hecht, funding is coming in at a rate of 500 percent of what was anticipated. In early October, the company will open funding to the general public. PsyRx's business model comprises five stages, explains Elishoov. First is the development and marketing of an improved antidepressant. Second, licensing agreements for production and sale of psychiatric medications. Third, selling raw psilocybin and ibogaine API for research and drug development. Fourth, exchanging technology usage rights (bioactors) for royalties. And, fifth, joint ventures with companies developing psilocybin- and ibogaine-based medications. "The medical cannabis revolution is being followed by the medical psychedelic revolution!" asserts Hecht.

in collaboration with PsyRx