FSD Pharma Announces Its Australian Entity Receives Approval to Proceed With Phase 1 Clinical Trial of Lucid-201, a Candidate for the Potential Treatment of Major Depressive Disorder

24 March 2023

FSD Pharma Inc. a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative, inflammatory and metabolic disorders, today announced that its Australian entity, FSD Pharma Australia Pty Ltd. received the certificate of approval from The Alfred Ethics Committee in Australia to proceed with a Phase 1 clinical trial of Lucid-201 (“Lucid-Psych”) as a novel drug candidate for the potential treatment of Major Depressive Disorder (“MDD”). Lucid-Psych is being developed outside of Australia by Lucid Psycheceuticals, Inc., a wholly owned subsidiary of FSD Pharma, and in Australia by FSD Pharma Australia Pty Ltd

Lucid-Psych is a psychoactive molecule selected as a potential therapeutic for MDD based upon the compound’s pharmaceutical and metabolic properties including employing machine learning algorithms, as well as for its potential proprietary position.

“Psychoactive molecules as new therapeutics for depression and other mental disorders represent some of the most exciting areas of clinical research in healthcare today,” said Dr. Lakshmi Kotra, CEO of FSD Pharma Australia Pty Ltd. “Today’s standard of care is prescribing antidepressants that merely mask the symptoms and are well documented to have a bevy of potential negative side effects. Hundreds of millions of people globally need new, safer, accessible and more effective options to redefine the front-line approach by getting to the root of the disorder and how it is currently treated. As we initiate the clinical stage for Lucid-Psych, our clinical team is optimistic that our novel drug candidate in a unique dosage form will be safe and tolerated.” Dr. Kotra further added, “We are also very cognizant of mental health challenges faced by those suffering from neurodegenerative disorders, such as multiple sclerosis, Alzheimer’s among others. As a company pursuing total brain health, we see Lucid-Psych a strategic fit for clinical development with our other pipeline programs.”

Major Depressive Disorder, sometimes called clinical depression, is a serious mental health disorder categorized by feelings of sadness or worthlessness, depressed mood, lack of motivation, and anhedonia, or reduced interest in activities once considered enjoyable. MDD can be a chronic condition with multiple periods of regression and relapse over a lifetime. Different types of MDD include Seasonal Affective Disorder (SAD), Postpartum depression, psychotic depression, melancholic depression, and catatonic depression. Broadly speaking, the National Institute of Health considers depression one of the most common mental disorders in the United States.1 An estimated 21.0 million adults in the U.S. had at least one major depressive episode in 2020, representing 8.4 percent of the country’s adults. In the same year, an estimated 4.1 million adolescents aged 12 to 17 in the U.S. had at least one major depressive episode, representing 17.0 percent of people in the age group. According to Allied Market Research, the global antidepressant drugs market size was valued at $15.65 billion in 2020 and is projected to reach $21.0 billion by 2030.2