Major Depressive Disorder
Depression is a serious medical illness and a global public health concern that can occur at any time over a person's life. While most people will experience a depressed mood at some point during their lifetime, major depressive disorder (MDD) is different. MDD is the chronic, pervasive feeling of utter unhappiness and suffering, which impairs daily functioning. Symptoms of MDD include diminished pleasure in activities, changes in appetite that result in weight changes, insomnia or oversleeping, psychomotor agitation, loss of energy or increased fatigue, feelings of worthlessness or inappropriate guilt, difficulty thinking, concentrating or making decisions, and thoughts of death or suicide and attempts at suicide. Currently available FDA-approved medications available in the multi-billion-dollar global antidepressant market often fall far short of satisfying the unmet medical needs of millions suffering from the debilitating effects of depression.
ACCORDING TO THE WORLD HEALTH ORGANIZATION (WHO), DEPRESSION IS THE LEADING CAUSE OF DISABILITY WORLDWIDE
SUFFER FROM DEPRESSION1
ONE MAJOR DEPRESSIVE EPISODE2
In a small peer-reviewed published exploratory Phase 2A clinical trial (n=30), PH10 was well-tolerated and, at a 6.4 microgram dose, demonstrated rapid-onset antidepressant effects (p=0.022), as measured by the Hamilton Depression Rating Scale (HAM-D-17), without systemic psychological side effects or safety concerns. PH10 is a potential new generation stand-alone antidepressant with a mechanism of action that is fundamentally different from all current antidepressants. PH10 has potential for multiple applications in global depression markets.
We are currently preparing our U.S. Investigational New Drug (IND) application to enable further clinical development of PH10 as a potential stand alone treatment for MDD in the U.S. We are currently planning to initiate a small Phase 1 study of PH10 in the U.S. in 2022 to facilitate potential Phase 2B development of PH10 beginning in 2023.
We may also have potential opportunities to develop PH10 for other depression-related disorders.