Brazil will test psychedelic mushrooms to create medicine

RIO DE JANEIRO, BRAZIL – A pioneering study for the development of medicines derived from psychedelics will be carried out by a public laboratory in Brazil, according to researchers from the Laboratory for Evaluation and Development of Biomaterials in the Northeast (Certbio) of the Federal University of Campina Grande (UFCG).

Due to its enormous technological potential, the laboratory, which has become known as the Silicon Valley of the countryside, has just received authorization from the National Health Surveillance Agency (Anvisa) to test psilocybin, the active principle present in the so-called magic mushrooms.

The research will evaluate the quantity and psychoactive components and test the potency (level of psilocin and psilocybin) of the psychedelic for end-use in patients in Brazil. Other important measurements will also be performed, such as observing the absence of heavy metals, pesticides, and contaminants and stability studies to determine the substance’s shelf life.

The researchers state that the project opens the way for developing drugs that may soon be available to the population. Shortly, it is believed that these products derived from psychedelic mushrooms may be indicated for serious conditions or those with a significant impact on public health, such as depression, anxiety, chemical dependency, and trauma, among others.

“This authorization allows the collection and extraction of psilocybin from mushrooms and the preparation of extracts for in vitro and animal tests to then begin clinical trials,” says Professor Suedina Silva, a UFCG researcher who is part of the coordination of the Psilocybin Project, a partnership between UFCG, Certbio, and the company Biocase Brasil, which also works with medicinal cannabis.

“It is the first step towards having a laboratory specialized in these finer and more technological measurements,” says physician Cesar Camara, CEO of Biocase Brazil. He adds that this is also the first public-private partnership for developing a psychedelic product for medical use in the country.

“This authorization inaugurated a cycle that should place Brazil within a virtuous wave that is already happening around the world and seeks a new look for ancestral treatments,” comments the doctor.

ADVANCES IN PSYCHEDELIC RESEARCH

Although it is still the beginning of a long way, the project of developing medicines derived from psychedelic mushrooms seems to have found fertile ground for it. The UFCG led the list of patent applications for invention in the country in 2020, according to the latest ranking of the National Institute of Industrial Property (Inpi).

According to Marcus Fook, a UFCG professor who is also leading the Psilocybin project, the laboratory is the only one in the country to produce medical-grade chitosan, a natural biopolymer obtained from the shells of crustaceans, such as shrimp, which has different applications for human and animal health and is currently one of the most researched in the world.

“It is this compound that will be tested in the nanoencapsulation of psilocybin for sublingual administration,” explains the researcher.

The goal is to move forward with patent development by the end of the year, says Biocase’s CEO. “This is more to show what we are doing to the world rather than impose restrictions; after all, it is a natural product,” says Camara. The objective, according to him, is to advance in the stages until a final product for clinical use in Brazil is achieved.

After the research with psilocybin by Certbio, when the product is ready or very close to it, Biocase is the one that takes over the clinical studies in phases 1 (with healthy people to determine safety), 2 (with patients to define dosage), and 3 (to verify efficacy), which is crucial to request registration.

“But none of this will happen without additional authorizations from Anvisa and Conep [National Commission of Ethics and Research, of the National Health Council],” points out the doctor.

BENEFITS OF PSILOCYBIN

The psychedelic therapy allows a long-lasting treatment with immediate effects, comments physician Romeu Fadul, scientific director of Biocase Brazil.

“In the case of psilocybin, a single session every six months or a year may be enough to treat, for example, severe depression, addictions, suicidal ideation in adolescents and adults, trauma, and the fear of death in patients with advanced oncological diseases.”

“It’s a complete paradigm shift,” Camara adds. According to the doctor, if the bets on psilocybin and psychedelic therapies, in general, are confirmed, they represent the most significant advance in mental health since Prozac (the most widely used antidepressant on the planet).

“In addition to the quality of life provided to patients, the impact on the world economy is estimated to be up to US$2 trillion per year.”

But there is still a lot of ground ahead, the doctor acknowledges. “According to our calculations, we will need four more licenses before applying for registration of a new drug,” Camara explains. And this, according to him, may take up to five years.

“Each stage will be a battle because we will have to show the need and the documented scientific results that justify this new product,” explains the doctor.

After the phase conducted by UFCG and Certbio researchers, clinical studies with psilocybin within research protocols will be conducted by the Alma Viva Institute, Biocase’s arm, to develop psychedelic therapies in Brazil. According to the company’s CEO, this stage should begin later this year in São Paulo.

The first research that Alma Viva is to conduct with Brazilian patients is scientifically based on a study authorized by the FDA (the U.S. Food and Drug Administration), which marked about a decade ago the resumption of research on these substances, opening the way for the current phase, known as the psychedelic renaissance.

Researchers at the Center for Psychedelic and Consciousness Research at Johns Hopkins University (USA), coordinated by scientist Roland Griffiths, administered psilocybin to patients with existential anxiety (fear of death) in the terminal stages of cancer.

“The study demonstrated an 80% positive response in controlling this type of anxiety in the group of patients studied,” comments Camara.

PSYCHEDELICS OUT OF THE CLOSET

One of the main hurdles is that psilocybin, like other psychedelics, is still on Anvisa’s list of psychotropic substances, notes lawyer Konstantin Gerber.

“This means that only registered drugs can be prescribed with these substances, and special authorization is required to research and manipulate them.”

So it’s still too early to probe whether a psilocybin-based drug will ever make it to Brazil’s Unified Health System (SUS) or predict when it will be available outside of research protocols.

But, especially in private clinics, other psychedelic therapies are already a reality—for example, treatments with ketamine, which in Brazil are already authorized. Treatments with ibogaine (derived from iboga, an African plant with psychedelic properties) have also been available in the country for some time.

Although there is no regulatory provision, therapies with the drug are not illegal here, says lawyer Emílio Figueiredo. “As there is no specific regulation, they are under the cloak of anomie [absence of rules].”

A novelty in the Brazilian scenario is the admittedly psychedelic clinics. It is the case, for example, with the Bienstar clinic, run by businessman Marco Algorta.

The idea, according to him, is to combat the prejudice that still exists concerning these substances. “We want to come out of the closet, show that we are really psychedelic,” says Algorta.

The businessman intends to create, in partnership with doctors, a network of psychedelic-assisted psychotherapy clinics in Brazil. “Our clinics are already functioning, and we have received our first patients for treatment with ibogaine, in Ourinhos, in the interior of São Paulo.

Algorta also predicts that his clinic will also be providing services in the city of São Paulo with ketamine in less than a month. “Our goal is to expand the treatments using other substances, always within the regulatory framework.”

With information from UOL