Earlier this month Biocase secured a licence from the Brazilian Ministry of Education, to train psychedelic-assisted therapists at Alma Viva Institute in São Paulo City. It was the first in Brazil to receive such a licence, and also the first to receive approval to conduct clinical trials with psilocybin.
Biocase’s postgraduate training will run alongside its Phase II trials with psilocybe cubensis, for the treatment of end-of-life anxiety in cancer patients.
PSYCH spoke to Dr Cesar Camara, CSO at Biocase, regarding the trials and psychedelic healthcare in Latin America.
‘Treating end-of-life anxiety is so important as almost everybody will suffer from it someday,’ explained Dr Camara. ‘Doctors are not prepared to treat patients with the condition as they don’t have the tools to assist patients through this period of life.
‘In my clinical practice, when a patient gets cancer – even if they recover – they live in the shadow of the cancer reappearing. They not only have the fear of the cancer reappearing, but also having to go through treatments like chemotherapy and radiotherapy, which are incredibly hard on the system.
‘If you’re in a good economic situation you can afford an extended course of psychotherapy, but it’s not normally something doctors prescribe and you have to look for it yourself.
‘Instead, patients are given anti-anxiety medication which only suppresses symptoms. Anti-anxiety medications typically do not only suppress feelings of anxiety, but suppress feelings. Life is passing them by without feeling and that is not good.
‘This is why psilocybin-assisted therapy could be such a game changer, as you may only need it once or twice. Psychedelic medicine could offer a different approach as patients may be able to look at life differently and look at their condition differently.
‘It is about being able to process feelings. When patients receive news that their condition is life threatening, they could live for another four or five years with the illness hanging over them. That could be a very long five years for the mind, for the body and for the soul.’
The company’s clinical trials reflect those designed at Johns Hopkins University. However, Biocase will use dried psilocybin-producing mushrooms instead of synthetic psilocybin. PSYCH asked Dr Camara about the approval process.
‘Licensing took two weeks as the protocol was well designed. As doctors we are used to producing clinical trials and federal agencies are open to well designed projects involving academics. People are sick and we have to bring alternatives to society.’
‘Government approval to conduct the clinical trial was important as it pushed people to think about the potential of psychedelic medicines, in addition to pushing the government to think about their regulation.e. If we can change things in Brazil, we might be able to change things across Latin America.’
In addition to Phase II clinical trials with whole fungi, Biocase has embarked on a huge psilocybin and psilocin extraction project, funded by two state agencies, leveraging its licence to cultivate psilocybe cubensis.
The extracted psilocin will be administered through nano encapsulation, PSYCH asked Dr Camara about the innovation.
‘Our intention was to produce something with fast action and also a short duration. With a duration between two and three hours we hope to deliver a treatment that is more affordable for patients.
‘If treatments require doctors or psychologists for five or six hours they can be very expensive. However, if the psychedelic experience lasts two hours and requires only one health practitioner, treatments can be delivered much cheaper. So our intention is to produce a faster onset and shorter duration through sublingual psilocin administration.
‘We began developing our nano-encapsulation technology at the beginning of this year and the intention is to submit a patent by July 2023. It may not be possible, but that is the ambitious timeline we’re working towards.
‘We intend to extract the psilocin from the psilocybin-producing mushrooms we cultivate to build that chain of knowledge. We have the expertise to produce psilocin in a lab, so we know that is a possibility, but we want to train people in natural extraction and create this chain of knowledge within the company.
‘We are involving two state agencies for funding, from the State of São Paulo and the State of Paraíba. The University of São Paulo will assist in the project to extract psilocin, and the state itself will help fund clinical trials. In Brazil, some state agencies have more money than federal agencies to fund these specific projects and it’s a big plus that Biocase has this level of support.’
With approval from federal and state agencies in Brazil, PSYCH questioned whether this support would help the organisation attract capital.
‘Absolutely,’ stated Mr Fadul – Biocase’s CEO. ‘However, we do not need any more investment for now. We have all the financial support we need for the next two or three years to develop clinical trials and register new drugs, but this is the very beginning. After that, we will need to conduct new clinical trials and new research.
‘At the moment we are focussing on a single product, nanoencapsulated psilocin. When the product reaches Phase II clinical trials and the efficacy of the innovation becomes apparent, I am pretty sure companies from the traditional pharmaceutical space will try to buy or licence the product.’
To facilitate international investment in Biocase, the company has developed a cryptocurrency. PSYCH was interested to learn about the purpose behind BIOTRIP.
In Brazil it’s much harder to list a company on the stock exchange than in North America, as it’s so tightly regulated. This is why we developed a cryptocurrency, as it enables investment outside of the stock market and enables any person around the world to invest a small amount of money to support the project.
‘We intend to market the BIOTRIP cryptocurrency at the MAPS congress in Denver, Colorado, with the aim to raise US$25m. The cryptocurrency will be backed by our psilocybin and psilocin products, instead of gold or silver(or nothing). All Biocase products will be sold through this cryptocurrency, so if the government wants to buy Biocase products they will have to invest in BIOTRIP tokens or adjust purchases based on it.
‘This may be the first time a cryptocurrency has been used to raise funds for psychedelic research, but it’s not the first time a cryptocurrency has been used to generate capital for healthcare startups.
‘Through the cryptocurrency everybody has the opportunity to invest in Biocase and support our research, whether they are students in Brazil or companies across North America and Europe. It really opens the company up to the world.’
Looking ahead to the future, PSYCH asked Mr. Fadul about Biocase’s ambitions.
‘As a Brazilian company we feel it is important to first produce, test and register our products in Brazil,’ declared Fadul. ‘We do intend to create a worldwide business, but we will start in Brazil under Brazilian regulations. The regulations in Brazil are strict in comparison to other Latin American countries, so we could expand into Argentina, Columbia and even into Central America.
‘Our intention is to produce all psychedelic medicines, maybe the next step will be ayahuasca. We originally chose psilocybin-producing mushrooms as there are no traditional populations involved in its use. It was simpler from that point of view and had already been tested by Johns Hopkins University and other academic institutions.
‘To use ayahuasca we would need to hold discussions with the players to understand how these could impact shamanic practices in Brazilian Amazonia. We would have to be careful to protect this community and learn if it’s possible to do something that is good for both us and them.
‘There are lots of economic opportunities here in Brazil, especially with a product that is affordable for the local population. We have the courage to be innovative and the courage to face the regulations. Regulators can only talk when the research has been presented, so we’re showing something concrete.’