Oligomerix Awarded $1.9 M NIH Phase II SBIR Fast-Track Grant to Conduct Safety Studies Required for Clinical Studies of OLX-07010 in Alzheimer’s Patients

-- Oligomerix achieves goals for NIH Fast-Track award supporting awarding the Phase II component to conduct the safety studies needed for 3-month dosing in Alzheimer’s disease patients for a planned Phase 1b study to evaluate OLX-07010, a small molecule inhibitor of tau protein self-association--

BRONX, N.Y.--(BUSINESS WIRE)--Oligomerix, Inc., a privately held clinical stage company pioneering the development of oral, small molecule therapeutics targeting Alzheimer’s (AD) and rare neurodegenerative diseases, announced an NIH Fast Track Phase II award of $1.9 million from the National Institute on Aging of the National Institutes of Health. This grant supports clinical development of OLX-07010, an orally administered investigational drug, targeting pathological tau aggregates that drive the progression of AD.

Description of study. To ensure the safety of investigational drugs for clinical trials, the FDA requires the performance of safety studies in animals that are used to determine the limits of dosing levels and duration in healthy volunteers and patients. To date, OLX-07010 has had a favorable safety profile in such studies. This 13-week dosing study in a non-rodent species compliments the already completed study in rodents and will enable the first safety study in Alzheimer’s patients of the same duration.

“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," said James Moe, Ph.D., MBA, President & CEO at Oligomerix. "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.”

This program has the potential to have a tremendous impact on the more than 7.4 million Americans who currently have AD (projected to be 13.8 million by 2060) and their caregivers. It holds the promise to help reduce the current cost of AD ($409 billion projected to be $1 trillion by 2050) to our nation (Alzheimer's Association 2026 Alzheimer's Disease Facts and Figures). The World Alzheimer Report projects there will be 288 million AD patients by 2050 driving an estimated cost of $2.8 trillion.

Research reported in this publication was supported by the National Institute on Aging of the National Institutes of Health under Award Number 4R44AG091987-02. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About Oligomerix’s Lead Program
OLX-07010 is a highly differentiated investigational drug that is an oral, self-administered, once-per-day medication that has demonstrated an ability to prevent the accumulation of tau protein in multiple transgenic animal models and has completed Phase 1a human testing. Given the recent approvals of new treatments for AD, Oligomerix is excited for the potential of its small molecule inhibitor targeting tau accumulation and at the possibility of offering patients a new therapeutic option.

About Oligomerix, Inc.
Oligomerix is a clinical-stage biotechnology company focused on discovering and developing novel, small-molecule inhibitors of proteins that accumulate in AD and rare neurodegenerative diseases such as progressive supranuclear palsy (PSP) and frontotemporal dementia (FTD) discovering inhibitors of protein self-association. The company’s headquarters and research laboratories are located at the Ullmann Research Center for Health Sciences within the Albert Einstein College of Medicine.

Oligomerix is seeking strategic partners and investors to support the acceleration and advancement of these important programs. For more information about Oligomerix, please visit our website at https://oligomerix.com/ and follow us on LinkedIn.