Novel Alzheimer’s Disease Treatment Enters Phase 2b Study

ADvantage Therapeutics, Inc. today announced that the U.K.'s Medicines and Healthcare Products Regulatory Agency granted the Company's lead compound AD04™ an Innovation Passport for treating Alzheimer's disease (AD) under the Innovative Licensing and Access Pathway (ILAP).

ILAP was established in 2021 to reduce the time to market innovative medicines in the U.K.

A Phase 2b trial for AD04™ in the ILAP application will be a randomized, placebo-controlled, double-blind study to confirm proof of concept and establish the safety and efficacy of AD04™ in mild AD patients.

A 2mg dose of AD04™ served as a control in a prior study of another compound, where it demonstrated a statistically significantly slower decline in outcomes (cognition, function, and quality of life) than other arms of that trial.

In addition, the AD04™ control group showed a slower decline in MRI-measured hippocampal volume as a biomarker of AD progression.

To date, preclinical studies have shown that AD04™ decreased the number of inflammatory microglial cells in the hippocampus of mouse models. Inflammation and hyperproliferation of microglial cells are pathological immunological events in the brain of Alzheimer's patients.

Dr. Rudolph Tanzi, who serves as Chair of the Scientific Advisory Board at ADvantage, stated in a press release on April 5, 2023, "The democratization of AD treatments that are safe, effective, and affordable for all are of utmost importance."

"We hope this AD04 trial with ILAP designation will bring us one step closer," he concluded.

ADvantage is located in Miami, Florida, and is developing potentially paradigm-changing therapies to treat AD in its labs at the Vienna BioCenter.

Additional AD vaccine and treatment news are posted at Precision Vaccinations.

Updated on April 11, 2023, with related links.