Pharmaceutical

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 COVID-19, epilepsy, anxiety, insomnia, and muscle inflammation.

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 as being free of THC and banned substances by informed Choice, NSF and INRS (a WADA certified lab)
  • NSF certified