Oligomerix Announces First-in-Human Dosing of Tau Self-Association Inhibitor OLX-07010
-- Phase 1a study will evaluate the safety and tolerability of OLX-07010 in healthy volunteers --
WHITE PLAINS, N.Y.--(BUSINESS WIRE)--Oligomerix, Inc., a privately held company pioneering the development of small molecule therapeutics targeting tau for rare neurodegenerative and Alzheimer’s diseases today announced the dosing of its first subjects in the company’s Phase 1a clinical trial evaluating lead candidate OLX-07010. This lead compound is a novel oral, small molecule inhibitor of tau self-association being assessed for the treatment of Alzheimer’s disease and other neurodegenerative disorders.
The objective of the Phase 1a study is to evaluate the safety and tolerability of OLX-07010 in single-ascending and multiple-ascending dose regimens in healthy volunteers, followed by the evaluation in a cohort of healthy elderly volunteers, the intended population.
“With its targeted safety and efficacy profile, OLX-07010 has the potential to fill a significant void in treatment options for patients suffering from devastating neurodegenerative diseases,” said James Moe, Ph.D., MBA, CEO and Head of Discovery and Strategy at Oligomerix. “I am proud of the entire Oligomerix team and excited to be part of this major milestone as we start our first-in-human clinical trial.”
In non-clinical, pharmacodynamic studies, OLX-07010 demonstrated robust efficacy across two different mouse models of neurodegeneration. Data from OLX-07010 non-clinical studies have been presented at world-class conferences and published in leading peer-reviewed neurology journals. In preclinical, IND-enabling studies, OLX-07010 was demonstrated to be an excellent candidate for clinical research.
“It is critical the neuroscience community continue its efforts to develop better treatment strategies for serious neurological disorders,” said William Erhardt, M.D., President and Head of Development & Operations at Oligomerix. “Over the last two years, Oligomerix has made significant progress in demonstrating how inhibiting tau self-association can have remarkable effects in preclinical models of AD and neurodegenerative conditions. With the start of this Phase 1a study, we look forward to working closely with our stakeholders, from patients to caregivers to regulatory officials, as we characterize the clinical profile of OLX-07010.”
Research reported in this publication was supported by the National Institute on Aging of the National Institutes of Health under Award Number 1R01AG076565-01. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
OLX-07010 is an oral, small molecule inhibitor of tau self-association that targets the beginning of the tau aggregation cascade, a process believed to be implicated in the development of Alzheimer’s disease and other neurodegenerative disorders. Oligomerix’s lead candidate has demonstrated efficacy in multiple animal models of tau-mediated neurodegeneration. OLX-07010 is currently being evaluated in a Phase 1a clinical trial in healthy subjects. For more information, please visit clinicaltrials.gov.
About Oligomerix, Inc.
Oligomerix is a clinical-stage biotechnology company focused on developing disease-modifying therapeutics for neurodegenerative diseases characterized by aberrant tau protein ranging from rare tauopathies such as progressive supranuclear palsy and frontotemporal dementia to Alzheimer’s disease.
Oligomerix discovers and develops differentiated, oral, small molecule inhibitors of tau self-association that are potentially easy to administer and cost-effective. Oligomerix’s portfolio of compounds is expected to provide a potentially lower-cost treatment alternative or complement the newly emerging high-cost therapeutic options such as monoclonal antibody products.
Oligomerix is headquartered at the Westchester Park Center in White Plains, New York and has lab facilities at the Ullmann Research Center for Health Sciences within the Albert Einstein College of Medicine. Follow Oligomerix on LinkedIn.
Oligomerix is seeking strategic partnerships to support the acceleration and advancement of these important programs. For more information about Oligomerix, please visit our website at https://oligomerix.com/.
Chief Commercial Officer
William Erhardt, M.D.
President & Head of Development & Operations
James Moe, Ph.D., MBA
CEO, Head of Discovery & Strategy