Local pharmaceutical company wins FDA approval for study of Alzheimer's and dementia drug

TAMPA —Alzamend Neuro has received permission from the U.S. Food and Drug Administration to move forward with a Phase 1 clinical study of AL001, a treatment for patients with Alzheimer’s disease and dementia.

In a statement released to investors Wednesday afternoon, CEO Stephan Jackman thanked the FDA for its expediency and says, “We are advancing the process and expect that the first patient will be dosed in September 2021.”

The company says AL001 is a lithium-based ionic cocrystal oral therapy for patients with dementia related to mild, moderate and severe cognitive impairment associated with Alzheimer’s disease. The first-in-human study is to determine “potential clinically safe and appropriate AL001 dosing in future studies.”  

Once the initial study is done, Alzamend say that it will start a Phase 1/2a clinical trial aimed at gauging the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of the drug in patients with Alzheimer’s.

Subsequent studies before final approval will look at dosing as well as the effectiveness and safety of the drug. The company say AL001 treatment has shown in preclinical studies to prevents cognitive deficits, depression and irritability in mice.

The company has said AL001 may wind up being able treat illnesses other than Alzheimer’s and dementia, including PTSD, bipolar disorder and depression.

Alzamend (Nasdaq: ALZN) is a Tampa-based preclinical stage biopharmaceutical company that is working on products to treat Alzheimer’s disease and dementia.

The company went public in June and is now listed on the NASDAQ Capital Market under the ticker symbol ALZN.

Alzamend announced June 17 that it raised $14.4 million from the IPO.