Oligomerix announced that it has received a $1.9 million NIH Fast-Track Phase II award from the National Institute on Aging of the National Institutes of Health.
The grant will support clinical development of OLX-07010, an orally administered investigational drug designed to target pathological tau aggregates that drive the progression of Alzheimer’s disease.
Oligomerix said it achieved the goals required for the NIH Fast-Track award, enabling the Phase II component to support safety studies needed for three-month dosing in Alzheimer’s disease patients. These studies are intended to support a planned Phase 1b study evaluating OLX-07010.
OLX-07010 is a small molecule inhibitor of tau protein self-association. The company said the drug has shown a favorable safety profile to date and has demonstrated the ability to prevent tau protein accumulation in multiple transgenic animal models. OLX-07010 has also completed Phase 1a human testing.
The NIH-supported work includes a 13-week dosing study in a non-rodent species. This study is designed to complement an already completed rodent study and help enable a safety study in Alzheimer’s patients of the same duration.
Oligomerix said the FDA requires animal safety studies to help determine dosing levels and treatment duration limits for investigational drugs before they are evaluated in healthy volunteers and patients.
The company is developing OLX-07010 as a potential oral, self-administered, once-daily treatment option for Alzheimer’s disease and other neurodegenerative diseases. Oligomerix said currently approved Alzheimer’s treatments are antibody-based and target amyloid through infusions or injections, leaving a need for disease-modifying therapies that are easier to administer.
The company said the program could have a significant impact given the growing prevalence and cost of Alzheimer’s disease. More than 7.4 million Americans currently have Alzheimer’s disease, a number projected to reach 13.8 million by 2060, according to the Alzheimer’s Association’s 2026 Alzheimer’s Disease Facts and Figures cited by the company.
Oligomerix is a clinical-stage biotechnology company focused on developing small-molecule inhibitors of proteins that accumulate in Alzheimer’s disease and rare neurodegenerative diseases, including progressive supranuclear palsy and frontotemporal dementia. The company is headquartered at the Ullmann Research Center for Health Sciences within the Albert Einstein College of Medicine.
KEY QUOTES:
“The prevalence of AD is increasing worldwide. While some new products have been FDA approved in recent years, they are all antibody-based treatments requiring infusions or injections targeting amyloid. There remains an urgent need for disease modifying drugs for AD that are cost-effective and easy to administer orally. OLX-07010 is progressing to fill this need with an economical, disease-modifying small molecule investigational drug that is stable and can be self-administered as a pill. Our goal is to ease some of the patient burden of AD by bringing a new, and potentially complementary, treatment option to the tens of millions of patients suffering from AD and other neurodegenerative diseases globally.”
James Moe, Ph.D., MBA, President and CEO of Oligomerix
