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Biologics are medications that are produced from living organisms and are used to treat a wide variety of conditions.
In recent years, the field of mental health has become more widely recognized as a critical facet of human health and wellbeing, spurring global attention, discussions and research. But while progress has been made to understand and treat various neuropsychiatric conditions, there remains a substantial unmet need, particularly for neuropsychiatry disorders like General Anxiety Disorder (GAD). These conditions affect millions of individuals worldwide and pose significant challenges to our healthcare systems and society at large.
F-Prime Capital and Eight Roads recently announced our investment in Engrail Therapeutics, a clinical-stage pharmaceutical company aspiring to become a leader in neuroscience. Their purpose is to deliver transformational therapies that improve the lives of patients with neuropsychiatric and neurodevelopmental disorders.
The Landscape of Neuropsychiatric Disorders
Neuropsychiatric disorders include a broad spectrum of conditions that involve disturbances in brain function, affecting cognition, emotion, behaviour, and social interaction. These disorders are often chronic and multifaceted, which complicates diagnosis, treatment, and management. In addition, the heterogeneity of symptoms and underlying neurobiological mechanisms make early diagnosis a formidable task and further underscores the importance of multidisciplinary and long-term sustainable approaches to care. In the past decade, both Medicare and private payors have improved coverage for psychiatric treatments, which enables faster adoption of novel branded psychiatric therapeutics.
Understanding General Anxiety Disorder (GAD)
GAD is a prevalent psychiatric chronic disorder characterized by chronic and uncontrollable worry and anxiety about everyday events and activities. Individuals with GAD often experience persistent anxiety and find it challenging to manage their concerns, leading to significant distress and impairment. The symptoms of GAD include restlessness, irritability, difficulty in concentrating, insomnia, muscle tension, gastrointestinal disturbances, and social withdrawal, to name a few. These can vary in severity and may manifest differently from person to person, however, for most, the symptoms can be debilitating and interfere with various aspects of life, including work, relationships, and overall well-being. Despite being one of the most prevalent mental health disorders, GAD is often under-diagnosed and effective treatment options remain limited.
In the US alone, there are more than 5M patients being treated with GAD as their primary psychiatric diagnosis, and over 60% are not adequately treated with current first- and second-line therapies.
Benzodiazepines are a class of medications that have shown strong efficacy and are commonly prescribed for the management of anxiety disorders, including GAD. These medications work by enhancing the activity of the neurotransmitter GABA, which has a calming effect on the brain. While benzodiazepines can provide rapid relief of anxiety symptoms, they are typically recommended for short-term, as needed treatment, but more chronic use of benzodiazepines is limited by titration requirement, cognitive impairment, sedation, interactions with alcohol and other drugs, abuse potential and withdrawal risks.
Engrail Therapeutics (Engrail): developing transformational therapies to improve the lives of patients
Engrail has developed a diverse portfolio with its lead asset (ENX-102) already in Phase 2 trials for GAD with a potential to expand to other related disorders. The company also has a rare neurological disease asset (ENX-103) in an ongoing named patient study, and a diverse portfolio with other neuropsychiatry assets that have demonstrated favourable pre-clinical profiles and present further upside in depression/anhedonia, PTSD/mood disorders.