Sage is focused on developing transformative medicines, and bringing hope for conditions with limited treatment options.
Our proprietary compounds target the GABA and NMDA receptor systems, critical regulators of nerve signaling in the brain. Dysfunction in these systems is known to be at the core of numerous disorders.
Our drug candidates are wholly-owned, internally-developed molecules designed to restore CNS balance by improving receptor sensitivity to natural nerve signals. Our lead program, brexanolone, is in Phase 3 clinical development for postpartum depression. We are developing next generation modulators, including SAGE-217 and SAGE-718, in various CNS disorders.
Postpartum depression is a biological complication of pregnancy that is estimated to affect 10-20% of new mothers in the U.S.1 During pregnancy, levels of certain hormones rise and then rapidly fall after giving birth.2 These hormone shifts may put some women at risk for developing postpartum depression.
Postpartum depression may have devastating consequences for a woman and for her family, which may include significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. There is no FDA-approved therapy specific for postpartum depression.3
Our Phase 3 Hummingbird Program includes clinical trials evaluating the safety and effectiveness of brexanolone injection in women with moderate to severe postpartum depression.
Major depressive disorder is a common but serious mood disorder, often affecting how a person feels, thinks, and handles daily activities. Approximately 16 million people in the U.S. suffer from major depression each year.4 While antidepressants are widely used for treatment, results from large scale studies suggest the need for additional options.5,6
GABA modulation is being explored as a different mechanism of action for treating major depressive disorder.7−9 Sage is testing SAGE-217 as an oral therapy for this disorder in a Phase 2 clinical trial.
Essential tremor is the most common movement disorder − 8 times more prevalent than Parkinson’s disease.1 It is a progressive, often inherited condition that causes rhythmic trembling of the hands, head, voice, or legs. Researchers think it may be caused by electrical fluctuations in the brain that send abnormal signals out to the muscles.2
For millions of people, essential tremor makes the simplest activities of daily life difficult, if not impossible. Tremors usually worsen with stress, fatigue and stimulant use.4
Essential tremor has been associated with reduction in GABA receptor activity.3,4 Our Phase 2 clinical trial is evaluating SAGE-217, a positive modulator of GABAA receptors, as a potential treatment for essential tremor.
Parkinson’s disease is a chronic and progressive movement disorder that affects approximately 700,000 people in the U.S.5 In this disease, nerve cells in the brain slowly stop producing dopamine, the neurotransmitter responsible for coordinating movement.6 As Parkinson’s disease progresses, dopamine produced in the brain decreases, leaving patients less able to direct their movement.
Parkinson’s disease may cause tremors, stiffness, slow movement and balance trouble, as well as mood changes and sleep difficulties. Current treatments for Parkinson’s disease focus on dopamine replacement, and are effective in reducing symptoms initially, but lose effectiveness over time.
GABA receptors may be a possible therapeutic target for patients with Parkinson’s disease. GABA signaling is known to help regulate the nerve cells that produce dopamine. Researchers have also found decreased levels of allopregnanolone, a naturally-occurring GABA modulator, in patients with Parkinson’s disease.7,8 Our Phase 2 clinical trial is evaluating SAGE-217 for its potential to treat the symptoms of Parkinson’s disease.