Magdalena has developed a paradigm shift in drug development with project initiation to start of POC trials in 12-24 months. The focus is novel, natural prescription medicines derived from plants for mental health indications including treatment of executive dysfunction in attention-deficit/hyperactivity disorder (ADHD) and cognitive deficits in schizophrenia (MB2500: its first botanical drug candidate). A second drug candidate has the potential to treat both positive and negative symptoms as well as the cognitive impairment of schizophrenia and the underlying MOAs to do this are understood.

Many commonly used neuropsychiatric medications have side effects such as personality changes or sedation. With centuries of use by indigenous healers and traditional psychiatrists, plant-derived medicines offer potential new MOAs for treating mental health disorders while being potentially safer than the small molecule drugs that may have “off target” effects.

ADHD and Executive Dysfunction

Magdalena has identified candidates in Jaguar’s plant library that may prove beneficial for addressing the executive dysfunction characteristic of ADHD

Once considered a childhood disorder with 9% of children in the US affected, ADHD is now acknowledged to persist into adulthood in approximately 50–65% of individuals and impacts an estimated 5.2% of U.S. adults aged 18–44.

Treatment of ADHD remains challenging. An estimated 20-50% of adult patients either are non-responders to stimulants or cannot tolerate the adverse effects of current therapeutics.

New therapeutics in development for the global ADHD market, which is projected to reach a value of US$18.69 billion by 2030 according to a report by Grand View Research, show promise but continue to have significant side effects.

Magdalena looks forward to developing a potential plant-based alternative drug for ADHD that is both safe and efficacious, especially with respect to executive function, the cognitive skill deficit found in almost all pediatric and adult ADHD patients.

Schizophrenia (afflicts almost 1% of people on the planet)

Cognitive deficit in patients with schizophrenia afflicts almost all patients with schizophrenia, part of the $7.5 billion-and-growing market for drugs to treat schizophrenia. Despite the number of antipsychotic medication options available for the treatment of schizophrenia, management of cognitive and negative symptoms is a largely unmet clinical need. There are currently no FDA-approved treatment options for management of cognitive and negative symptoms of schizophrenia, although there are potential medications in phase II and phase III trials in third-party pipelines.