Natural psilocybin: Biocase raises R$ 10 million from FINEP for depression
R$ 10 million support from FINEP boosts study with natural psilocybin to treat treatment-resistant depression. Read more and check out the details of the study!
Natural psilocybin for the treatment of major and treatment-resistant depression is the focus of a promising new scientific advance in Brazil. Pharmaceutical company Biocase was awarded nearly R$ 10 million in non-repayable funds in the 2nd round of the FINEP Saúde Mais Inovação program.
The million-dollar funding will be allocated to Phase 1 and 2 clinical trials. The goal is to enable the regulation of a compound-based medication for managing treatment-resistant depression and other mental disorders backed by scientific evidence.
It is worth noting that Phase 3 is not covered by this initial contribution. The project, which features broad academic collaboration, now advances to a decisive phase to forge new paths in mental health.
“This support allows us to transform years of scientific development into clinical research and advance the development, in Brazil, of new paths for mental health,” states César Câmara, CEO of Biocase.
[READ MORE: Understand how psychedelic compounds work in modern medicine]
What is FINEP and how does the FINEP Saúde Mais Inovação program work?
The Brazilian Innovation Agency (FINEP) is a public company linked to the Ministry of Science, Technology and Innovation. Its primary function is funding research, innovation, and scientific and technological development in Brazilian companies, universities, and institutes.
Through the 2nd round of the FINEP Saúde Mais Inovação call for proposals, the institution grants non-repayable financial resources to boost strategic projects in the country.
The program's goal is to strengthen the production and research of cutting-edge technologies and innovative health solutions across the national territory.
Next steps in clinical research and ANVISA's role
The project now enters a decisive phase for its practical execution. By late August, Biocase is expected to submit the Investigational New Drug Dossier to the National Health Surveillance Agency (ANVISA).
The goal of the submission is to request the Special Notice for the formal start of the Phase 1 clinical study. This research protocol has already been duly approved by the CEP/CONEP system.
[READ MORE: How the clinical research approval process works in Brazil]
According to Biocase, the preclinical stages have been completed, with adjustments to occur during clinical studies (in humans) to improve storage conditions for the API.
Thus, by the end of August, the dossier will be filed with Anvisa requesting the document regulating the conduct of the phase 1 study, which is already backed by official ethical approval in the CEP/CONEP system.
Biocase is part of Latin America's largest Health Innovation Hub, Inova-HC, with prospects of conducting these studies within the HCFMUSP complex.
Scientific evidence and the potential revolution in treating treatment-resistant depression
The use of the substance is backed by well-founded studies in renowned publications, such as Nature, JAMA, and The New England Journal of Medicine (NEJM). The compound's efficacy is also evaluated by leading global university centers, such as UCSF, Harvard, Johns Hopkins, and Royal College London.
Based on this body of evidence, the medical community notes that there is a huge possibility for this therapeutic class to represent a true revolution in the treatment of mental disorders.
Many experts compare the potential impact of this innovation to the historical milestone brought by the arrival of Prozac in psychiatry in the 1980s.
Bibliographic References
Biocase / FINEP: Official announcement regarding the award of non-repayable funds from the 2nd round of the FINEP Saúde Mais Inovação program for a clinical study with natural psilocybin.
CEP/CONEP System & ANVISA: Approved protocol and guidelines for the submission of the Investigational New Drug Dossier and Special Notice.
Scientific and Academic Studies: Reference publications and research on psilocybin in journals (Nature, JAMA, NEJM) and universities (Harvard, Johns Hopkins, UCSF, Royal College London).