Psychedelic drugs, with a little push and encouragement from the FDA, have become one of the promising new directions in pharmaceutical R&D. After decades of abstinence, humanity is beginning to head back to its roots (pun intended!), as well as to mushrooms. Massive investments are being funneled into R&D towards finding innovative solutions to treat anxiety, depression, post trauma, and addiction. Israeli company PsyRx, led by former Associate Director General of the Ministry of Health, Prof. Itamar Grotto, is developing unique technologies for growing and producing these types of substances. Soon, the company will launch its first clinical trial, and (will likely) go public.
PsyRx’s main strategic direction is what is known as combination drugs, such as: the combination of Ibogaine, an active ingredient based on African iboga root, with existing SSRI-group medications (such as Prozac®, Cipralex®, and Recital®). The Ibogaine is meant to prevent and relieve some of the SSRI group’s known side effects, such as sleep disruptions, changes in appetite, and decreased libido. It can even potentially and drastically lower the “adjustment period,” before these drugs begin to have an effect on patients’ moods – from an average of six weeks to mere days.
The company will soon begin testing on mice, after which their first clinical trial will launch. The next stage will be to receive FDA approval. According to Prof. Grotto, as the company is working on a combination drug, approval is expected to be accelerated. “There’s no need to prove that the existing drug is safe, and Ibogaine has a rich and proven history as well. All that’s left to do is prove that they are still safe when used together and, of course, that our desired impact is achieved.” As such, the clinical trial will be equivalent to a Phase 2B trial, and the company will continue working on simultaneously submitting its Pre-IND to the FDA.
One particular regulatory challenge stems from the fact that, thus far, mostly synthetic materials have been used. Prof. Grotto indicates that extracting the active ingredient through a biological process enables the company to work with molecules in different forms, which, in turn, is accelerating their efforts towards finding the optimal solution. He compares this process to a key and a lock. Here, there is an additional benefit, which makes working with psychedelic substances simpler than, for example, working with medical cannabis. “We are able to precisely isolate the active ingredient – the molecule – and do not need the entire mushroom or root. It’s different from cannabis, which contains hundreds of chemical substances with reciprocal effects. There’s also a challenge linked to getting the same effect from each use – the plant’s famous reproducibility problem – and there are still quite a few questions yet to be answered.”
Unlike the way psychedelic substances were once used, this time, the goal is to provide them in very small doses, PsyRx’s CEO says. First, within the framework of the study, patients will consume the substance as an external substance to the drug, in the form of a separate powder-based capsule. Later, it might be added into anti-depressant drugs as one of their ingredients.
Great news for Crohn’s and Colitis patients
The combination drug is just one of PsyRx’s strategic directions. Another direction is growing and producing the substance itself – the Ibogaine, as well as Psilocybin, a chemical compound produced by mushrooms from the Psilocybe families (known as hallucinogenic mushrooms). The company completes this process using advanced technologies, as part of a collaboration with the Hebrew University of Jerusalem’s Faculty of Agriculture in Rehovot. Its innovative technology enables the company to save on growing the entire mushroom; they can produce the substance using the mushroom’s mycelium; the net that grows underneath it, just above the ground. In this way, costs can be cut, processes can be shortened, and a high level of reproducibility can be achieved.
Prof. Grotto indicates that the art of growing and producing these substances has already been mastered, and the company is now during formulating and licensing an official protocol. The challenge will be in transitioning from the laboratory to commercial use, as the intention is for these substances to be used in the same combination drug. The clinical trial should make use of those substances produced in-house. Later, they should be marketed as raw ingredients, to increase the company’s revenues.
A third direction is the use of psychedelic drugs to treat irritable bowel syndromes (IBD), such as Crohn’s or Colitis. “The assumption is that these diagnoses share a connection to psychological factors, as the intestine is home to Psilocybin receptors. Here too, there’s a desire to combine the substance with existing medications. The common denominator shared by all cases is, in essence, the fact that modern medicine doesn’t provide them with adequate solutions. As such, these combination drugs could be revolutionary for millions of people suffering from chronic illnesses.”
Prof. Grotto joined the company in March of 2022. The original concept that became PsyRx was conceived by the company’s CEO, Itai Hecht, an entrepreneur with vast experience in the private and public sectors. It was Itai who led the first-ever cannabis company IPO at the Tel Aviv Stock Exchange, and subsequently jumped on board biotech entrepreneur Dr. Kobi Buxdorf’s bandwagon, together with entrepreneur and physicist, Dr. Asher Holtzer. Thus far, 5.5 million NIS have been raised at a valuation of 20 million NIS. Soon, the company will kickstart another funding round, in the hopes of raising the same amount of money, at a valuation of 40 million NIS. Following the funding round, the company is expected to go public.
“The field of psychedelic drugs is growing at an accelerated rate,” Prof. Grotto says. “This growth is related to the rise in instances of anxiety and depression, brought on by Covid-19, as well as by increases in opioid addictions, which has already become a deadly plague in and of itself, in places like the US. Today, there are companies with 2.5 million dollars that produce synthetic psilocybin to treat depression and other nervous system issues. There’s a real thirst for a biological solution and our unique production technique, especially in the field of Ibogaine, which is less researched.” When will we be able to find this solution on pharmacy shelves? “Prescription drug approval tends to take at least 10 years. Thanks to our amassed knowledge and the FDA’s accelerated track to approval, I cautiously estimate that we’ll be there in 3-4 years.”
Partnered with PsyRx