Aramis Biosciences Announces FDA Clearance of IND Application for A197, a Novel Immunomodulatory Agent for the Treatment of Dry Eye Disease
Aramis Biosciences plans to initiate a Phase II clinical trial in Q1 2022
Boston, MA (January 11, 2022) – Aramis Biosciences, Inc., a clinical-stage immuno-ophthalmology biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for A197 enabling the company to proceed with a Phase II proof of concept clinical trial.
“We are pleased that FDA has cleared A197 to move into Phase II clinical trials in dry eye patients. We believe that A197, with its novel mechanism of action targeting the immunopathogenesis of the disease and clean tolerability profile, has the potential to significantly improve the standard of care in dry eye disease,” said David S. Tierney, M.D., Aramis Biosciences’ President and CEO. “With less than 5 percent of dry eye patients satisfied with available treatments, we look forward to moving this promising investigational therapy into the clinic.”
About Dry Eye Disease
Dry eye disease is an extremely common, chronic, immune-mediated disease driven and perpetuated by a distinct subset of pro-inflammatory T helper cells, resulting in epithelial cell damage and ocular discomfort. While 17.8 million Americans have been diagnosed with dry eye disease, fewer than 1 million (1 in 20) are currently being treated with an FDA-approved product; presumably due to questionable efficacy and tolerability limitations. There are many risk factors including advanced age, female gender, autoimmune disorders, diabetes, certain medications, increased screen time, LASIK, contact lens use and environmental factors such as pollution.
Dry eye disease is best characterized as an immunological response originating from an imbalance in the protective immunoregulatory versus pro-inflammatory pathways of the ocular surface. Chronic dry eye is believed to be the result of a ‘vicious cycle’ of inflammatory responses perpetuated by the resistance of a pathogenic subset of pro-inflammatory T helper cells to suppression by regulatory T cells (Treg).
About Aramis Biosciences
Aramis Biosciences is a clinical-stage immuno-ophthalmology biopharmaceutical company committed to the development of disease-modifying therapy for ocular surface disease. Founded by leading experts in the fields of corneal disorders, ocular inflammation and immunology from The Schepens Eye Research Institute of Mass Eye and Ear and Department of Ophthalmology at Harvard Medical School, and with support from Safar Partners, Dompé farmaceutici S.p.A., and a global leader in ophthalmic pharmaceuticals, Aramis Biosciences is advancing its lead product candidate, A197, a novel, first-in-class, topical immunomodulatory agent into Phase II clinical proof of concept for the treatment of dry eye disease. For more about Aramis Biosciences, visit https://www.aramisbio.com.
David S. Tierney, M.D.
President and CEO