Encouraging Results from a Phase 2 Study of IL-2 to Treat Alzheimer’s Patients

BioSpace recently published a press release discussing the interim results highlighting a Coya Therapeutics’ study. The study evaluates the safety, tolerability, and biological activity of LD IL-2 in 38 patients with mild to moderate Alzheimer’s disease (AD). Dr. Alireza Faridar and Dr. Stanley Appel at the Methodist Hospital in Houston, Texas led the study. It is to be noted that IL-2 had been initially FDA-approved to treat skin cancer.

Dr. Faridar’s team conducted preliminary studies using mice models that were genetically engineered. The Alzheimer’s-like models indicated that Interleukin-2 (IL-2) may improve Tregs activity and restore the original function of suppressing inflammation of the brain.

In addition, cerebrospinal fluid and blood biomarkers plus neuroimaging results and any changes in cognitive performance will be assessed across various patient populations.

Further details from the Phase 2 trial highlighting the significant improvement in cognitive function compared to baseline from an earlier trial will be forthcoming in mid-2024.

Dr. Fred Grossman is President of Coya Therapeutics. The doctor stressed the importance of this study which will expand the company’s pipeline. He is looking forward to the release of data and the anticipated top of the line results.

About the Immune System

The immune system in the brain serves to maintain healthy immune cells. One of its lesser-known roles is associated with Tregs (regulatory T cells). Previous studies have identified Tregs and their protective role in the suppression of brain inflammation.

Researchers have discovered that people with AD have increased levels of inflammation in their brains. One of the goals of the Phase 2 trial is to establish whether a chemical compound could have an impact on brain inflammation as a treatment for AD.

Prior research by Dr. Faridar and his colleagues indicates that people with AD may no longer be able to block the inflammation caused by their immune system. The researchers also observed that IL-2 appeared to have made improvements in participants’ cognitive function.

About the Phase 2 Trial

The Phase 2 trial involved 38 participants who were randomly treated with subcutaneous (beneath the skin) LD IL-2 or matching placebo for 21 weeks. After the last dose, patients participated in a nine-week follow-up. In an ongoing Phase 1 clinical trial the researchers administered IL-2 in a small number of individuals with mild to moderate Alzheimer’s. The preliminary results showed that IL-2 could be safe and tolerated by the participants. Additionally, the researchers observed that IL-2 may have significantly improved cognitive function in these participants. Dr. Faridar’s team will be exploring its use as a potential treatment for Alzheimer’s.

About Alzheimer’s

Dementia is an “umbrella” term for memory loss, while Alzheimer’s disease is the most commonly reported cause of dementia. Alzheimer’s represents approximately 80% of known dementia cases affecting about 5.7 million people in the U.S. Over 90% of people diagnosed with Alzheimer’s do not experience symptoms of dementia until they reach the age of 65. Then the symptoms begin to double every five years. According to the National Institute of Health, Alzheimer’s is the sixth cause of death in the U.S. and for people over age 65 it is the fifth leading cause.

Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia (AML) six years ago. During this period of partial remission, Rose researched investigational drugs to be prepared in the event of a relapse. Her husband died February 12, 2021 with a rare and unexplained occurrence of liver cancer possibly unrelated to AML.

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