Karen Brunke

Acting CEO at Magdalena Biosciences, Inc.

Presenter

Filament Health (Filament) and Jaguar Health (Jaguar) joined forces in early 2023 to create Magdalena Biosciences, Inc. in order to leverage their mutual expertise in botanical drug development, plant sourcing and sustainable supply, scientific advisors, neuroscience capabilities, regulatory experience with FDA for botanical drug approval, benefit sharing with indigenous populations, expertise in clinical development, manufacturing, bioassay preparation and performance, and Jaguar’s knowledge-based library of plants and extracts. OneSmallPlanet (OSP), who made the seed investment in Magdalena, invests in programs where there is benefit sharing with indigenous populations, including drug development programs. The focus of Magdalena Biosciences, Inc. (Magdalena) is the development of botanical drugs under FDA Botanical Guidance, targeting the initial indications of schizophrenia, attention deficit hyperactivity disorder (ADHD), social anxiety disorder, and depression. In addition, Magdalena has prepared a dossier of safety information from the human experience for the Company's first IND-enabled botanical drug along with the clinical study protocol and drug master file (DMF) and will do so for additional botanical drugs for ADHD, schizophrenia, depression and anxiety, among other neuropsychiatric indications. With pre-IND discussion with FDA, any further in vitro testing or limited toxicology if needed will be performed and Magdalena will be ready to begin clinical studies with Series A funding. Two more botanical drugs will be IND-enabled in 2025. In some cases, the first clinical study will be a Ph 2 study based on centuries of safe use in humans by traditional healers and, sometimes, decades of non-clinical use as a supplement. This process of reaching a POC clinical study within 18 months of program commencement in contrast to the 6 years or more for small molecule drugs, saves time, risk, and money.