Taking a Chemistry-Led, Patient-Centric Approach to Psychedelic Medicine
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After decades of prohibition, psychedelic research is going through a modern renaissance. Powered by technologies that did not exist during the original psychedelic science boom of the mid-20th century, today’s scientists are on a mission to create new, next-generation psychedelic medicines that can better serve patients’ needs.
Psilera Bioscience is one of these young biotechnology firms taking a novel approach to psychedelic science. Led by experienced natural products chemists, Psilera takes its inspiration from natural psychedelics and combines this with cutting-edge computational modelling on its mission to identify new psychedelic analogs and chemical entities that might revolutionize the psychedelics space.
Centering patient experience and sustainability
A core aim of Psilera’s is to create new psychedelic drug formulation that can be administered in novel ways, which would allow patients undergoing psychedelic-assisted psychotherapy to access a greater range of treatment options. For example, a transdermal patch could give patients the option to receive sub-psychedelic doses of a drug, potentially avoiding the need for extended inpatient visits to psychedelic clinics.
“The focus is for it to be very patient-friendly and for it to be something that a patient will want to do and not be afraid to do. I think that that’s not necessarily the approach a lot of other companies are taking,” Dr Jackie von Salm, co-founder and chief scientific officer of Psilera Bioscience, told Analytical Cannabis.
“There’s sort of this bubble that people get into and assume that everybody wants to take a psychedelic and be hallucinating and having a great time, whereas there’s a lot of people that are going to be dubious.”
“From the beginning, we have always kept that in mind. Especially someone with PTSD or anxiety, like veterans, who aren’t going to sit in a room blindfolded for six hours with a stranger. We really wanted to make [psychedelic medicine] so that it was much more open access and much more patient-friendly.”
As a team led by experienced natural products chemists, Psilera’s co-founder and CEO Dr Chris Witowski says that they were drawn to naturally-occurring psychedelic compounds as the starting point for their research. However, since many of these natural psychedelics can also be synthesized in a laboratory, this focus shifted to optimizing synthetic formulations of these compounds so that they are suitable for patient use and also easily fit within current regulatory regimes.
“More than 60 percent of current FDA approved drugs are derived from natural products, so it’s always a pretty good starting point,” said Witowski. “For us, we’re looking at it from more of a biotechnology play and having patients have access to [these medicines] through insurance practices that are very regimented, very reproducible for specific indications so that they can get reimbursement from insurance agencies.”
“One of the things that makes [plants] so amazing is that they can adapt and they’re diverse,” von Salm added. “But that adaptation and diversity leads to a lot of variability in the chemistry, and then when you’re trying to make medicine that’s going to treat someone regularly and consistently [...] it’s hard to always get that from a natural source, unfortunately.”
Focusing on synthetic psychedelics inspired by nature can also be a far more sustainable approach than directly using natural plants, von Salm explains.
“Usually [psychedelics] are less than one percent of the overall mass [of the plant]. With something like DMT, we don’t want to start going around and destroying all of the plants or vines or things that it would take for us to even try and come up with the smallest amount of DMT when that synthetic route for DMT is one step,” von Salm said. “It’s a very straightforward molecule, it just would be silly to start going out and pillaging the rainforest for all this DMT if you don’t have to.”
Using computational chemistry to understand psychedelics
Psilera Bioscience is a member of the University of South Florida Connect Incubator program, which gives the company access to laboratories and collaborations within the university to progress the development of commercialized products.
“That allows us to work with the substances, develop compounds and formulations,” explained Witowski. “We’re just now starting to get into pre-clinical studies and testing some of these new psychedelic compounds and derivatives in animals and testing to see whether or not they’re psychedelic, and that’s something that we’ve already done some initial computational analysis with.”
Although the serotonin 5-HT2A receptor is the main receptor where psychedelic activity is seen, Psilera is also focused on other receptors, such as the serotonin receptors or sigma-1 receptors that are important targets for traditional antidepressants. By examining the activity of different chemical entities across this broader range of receptors – computationally, and then with further experimental studies – the team hopes to develop new patient-friendly drugs that may not carry the same psychedelic trip as DMT or psilocybin, but which could still be effective for use in therapy.
“We get asked all the time how we’re any different than any of the pharmaceutical and biotechnology companies that have been trying to do this for the last 20 or 30 years. [We want to] reduce 5-HT2A activity whilst still maintaining a lot of these other antidepressant or anti-anxiolytic activities,” said von Salm. “We are looking at the entire activity profile and comparing that back to not only known psychedelics, but also known psychoactive compounds that have been FDA approved that are already antidepressants, and really homing in on compounds that have unique activity profiles across many receptors.”
“It kind of goes back to trying to make patient-friendly delivery devices and drugs so that you don’t have to go into a clinic and have a four-to six-hour trip. This is looking at the next generation of psychedelic drug therapies, if you want to call it that. These types of tools are going to be invaluable as we start to move forward and innovate these types of therapies.”
“Computational screening isn’t full-proof, but it’s a great tool,” Witowski added. “We’ve done a lot of the early validation work and have gotten extremely good results. That’s a really good foundation for as we continue to innovate new chemical entities, we can continue to bring in new compounds and publish literature and patents that identify some of these compounds which would have the unique activity that we’re looking for.”
Psilera Bioscience is currently in the process of filing an Investigational New Drug (IND) application with the US Food and Drug Administration for its DMT transdermal patch, with a view to enrolling the first group of patients for an initial trial in 2022. A DMT nasal gel is also currently going through pre-IND filing studies, including pharmacokinetic analysis on animals to determine appropriate dosages before human trials can begin, with its IND filing expected to follow next year.