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The CBD-based pharmaceutical drug market is growing rapidly, powered by increasing scientific research indicating the positive therapeutic potential of CBD actives in a wide variety of health areas including central nervous system diseases, pain disorders, cancer, insomnia, anxiety and more.
Research and Trial Opportunities
Acknowledging the critical opportunities and gaps in cannabinoid research and data, Brains has undertaken to provide evidence to support the efficacy and safety of phyto-cannabinoid in the treatment of major diseases, partnering with numerous companies and institutions conducting pre-clinical research and clinical trials in various jurisdictions.
As one of the world’s few registered GMP-grade natural CBD API’s, Brains Bio’s CBD API is in increasing demand and is currently being utilized in 15 clinical trials around the world, exploring the effects of CBD on treating epilepsy,
psychosis, anxiety & depression and PTSD.
Brains is the exclusive supplier of pharmaceutical-grade natural CBD API to Prati Donaduzzi, for their Phase III clinical trial on refractory epilepsy. Marketing Authorization is anticipated 2022.
Evidence-Based Approach
Brains Bio has a multi-pronged, capital-light approach to invest in early-stage preclinical and clinical proof of concept pharmaceutical initiatives with multiple opportunities for monetization. The identification of pharmaceutical investment opportunities by Brains Bio will include identifying indications based on the Company’s judgement of a high probability of clinical success, clear regulatory pathways and commercial attractiveness.
Brains Bio’s market leading position is further enhanced by its regulatory package, which includes
- An actively maintained EU Active Substance Master File (ASMF).
- A US Drug Master File (DMF) filed with the US Food and Drug Administration (FDA),
- Drug Substance (DS) section of the Investigational Medicinal Product Dossier (IMPD)
- German DAC monograph compliant.
- Drug Product (DP) section of the IMPD available from a third party partner company
- 36-Month stability data.
- Over 350 commercial batches manufactured with resulting batch consistency and standardization data.
- Approved IND filings with the US FDA. Non-GMO, Kosher, Halal
- Tested for the absence of THC and banned substances by informed Choice, NSF and INRS (a WADA certified lab)
- NSF certified
Brains continues to support the development of clinical trials worldwide.
Brains Bioceutical is an exclusive supplier of natural pharma grade CBD API to Prati Donaduzzi & Cia Ltda, Brazil for their ongoing clinical research and clinical trials. One of their prime studies currently at phase-3 stage is to Evaluate the Efficacy and Safety of Cannabidiol as an add-on Therapy for the Treatment of Refractory Epileptic Crisis in Children and Adolescents. Reference
Prati Donaduzzi also received CBD sanitary authorisation from ANVSA (Brazil) in Apr2020 using Brains CBD API, as the first product approved under revised regulatory changes occurred in Brazil for CBD in in Dec-2019. Reference
MHRA approved Clinical Trial being undertaken by a Brains Bio joint venture being conducted at King’s College, London, assessing the enhanced bioavailability of a proprietary oral formulation against ordinary CBD. In human PK Study.
An approved investigational new drug (IND) for a PK study to use as a precursor in an Opiate addiction study with Icahn School of Medicine at the Icahn School of Medicine at Mount Sinai in New York, NY. API. . Reference
In human Schedule 3 Therapeutic Goods Administration (“TGA”) approved Proof of
Concept Study using CBD as a treatment for Insomnia, undertaken by BTT Life Sciences at Swinburne University of Technology, Australia Reference
In human, double arm Schedule 3 and Schedule 4 TGA approved Proof of Concept Studies using CBD as a treatment for muscle inflammation, undertaken by BTT, determining the effects of short-term oral CBD use on inflammation, muscle damage and functional recovery following downhill running. The study is being undertaken at Swinburne University, Australia and is due to be read out in Q4 2022. Reference
A clinical research team from the University of São Paulo, Brazil performed clinical research trials using Brain’s CBD in children having refractory epilepsy. The preliminary evidence has confirmed the effective role of CBD in epilepsy treatment. Also, these studies have reiterated the importance of sourcing pure CBD material to find out actual research findings. The findings from this study are published in Frontiers in
Pharmacology. Reference
The research team from the University of São Paulo, Brazil, using Brain’s CBD, conducted research on humans for the dose-dependent responsive effect of CBD on anxiety. The trials had shown that the subjects with CBD at low doses also shown significant attenuation of anxiety and it increased with the dose increments. Reference
A research team from the Federal University of Parana, Brazil had performed a trial in rats using Brains CBD and confirmed the anti-depressant activity of CBD in Rats, and a similar hypothesis is being proposed to act in Humans. Thereafter human studies are underway. Reference
Studies performed at the University of São Paulo, Brazil, using Brains CBD in pregnant rats have proven the role of CBD in promoting anti-inflammatory effects and these studies were published in the Brazilian Journal of medical and biological research. Reference
A clinical trial from the National Institute of Science and Technology for Translational Medicine, Brazil, using Brains CBD had shown that CBD could restore the epigenetic modulations of mitochondria in the hippocampus and may be directly involved in neuroprotective properties. Reference
A research study conducted in Zebrafish using Brains CBD at the University of São Paulo, Brazil, assayed the neurological toxicity of CBD exposure. These trials confirmed that CBD does not induce any neurotoxicity, thus not affecting any developmental process. Reference
A research team from The Australian Centre for Cannabinoid Clinical and Research Excellence (ACRE), Australia, has performed clinical trials in humans using Brains’ CBD and published their findings in the journal of Cannabis and Cannabinoid Research (2018). This study had shown that prolonged use of CBD in Cannabis users appears to have a promising improvement in psychological symptoms and cognition function. These preliminary studies are being further investigated and validation studies are ongoing. Reference
The same research team from Australia also performed another trial using Brains CBD again in humans to find out whether prolonged administration of CBD would reverse the damages that occurred in the brain in chronic cannabis users. The findings from this study are also published in Cannabis and Cannabinoid Research (2018), and the result surprisingly has shown that CBD may be useful in treatments for Cannabis dependence patients and could support in treating such patients with characterized hippocampus pathology. Reference
A 12-week pilot study, “The Cannabidiol youth anxiety pilot study (CAPS)”, performed in young male and female participants of age 12-25 years using Brains CBD at Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia has shown therapeutic effects of CBD on anxiety in youth. These basic study results are used to perform a detailed study further. Reference
An investigation team from Austria performed in-vitro studies using Brain’s CBD in an artificially simulated gastric fluid has concluded that orally consumed CBD would not get converted into THC in the human gastric system. These findings have nullified many arguments about the conversation of CBD into THC in normal oral consumption scenarios. Reference
