Alzamend Neuro Submits IND Application for a Phase IIA Clinical Trial in Major Depressive Disorder Patients of its Next‑Generation Lithium Therapeutic Drug Candidate AL001 - Seite 2

After receipt of a “study may proceed” communication from the FDA, Alzamend plans to initiate a Phase IIA study to characterize AL001 improvements of lithium levels in the brain compared to a marketed lithium salt in MDD patients. Alzamend anticipates that this program may, based on safety, qualify for a 505(b)(2) NDA pathway to FDA approval, which is available to new formulations of an approved drug.

“This IND submission represents the next key milestone for Alzamend as we further advance our proprietary pipeline,” said Stephan Jackman, Chief Executive Officer of Alzamend. “Being able to develop a next-generation lithium product (AL001) that would not routinely require TDM could positively impact the 21 million Americans afflicted with MDD. We look forward to providing more details regarding the study’s timeline and market opportunity in the near future.”

About Major Depressive Disorder

MDD, also known simply as depression, is a mental disorder characterized by at least two weeks of pervasive low mood, low self-esteem, and loss of interest or pleasure in normally enjoyable activities. Those affected may also occasionally have delusions or hallucinations. Introduced by a group of U.S. clinicians in the mid-1970s, the term was adopted by the American Psychiatric Association for this symptom cluster under mood disorders in the 1980 version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-III) and has become widely used since. The diagnosis of MDD is based on the person’s reported experiences and a mental status examination. There is no laboratory test for the disorder, but testing may be done to rule out physical conditions that can cause similar symptoms. The most common time of onset is in a person’s 20s, with females affected about twice as often as males. The course of the disorder varies widely, from one episode lasting months, to a lifelong disorder with recurrent major depressive episodes. MDD is believed to be caused by a combination of genetic, environmental, and psychological factors, with about 40% of the risk being genetic. Risk factors include a family history of the condition, major life changes, certain medications, chronic health problems, and substance use. It can negatively affect a person’s personal life, work life, or education as well as sleeping, eating habits, and general health. According to the World Health Organization, approximately 280 million people (3.8% of the world’s population) in the world suffer from MDD.