Topline proof of concept data anticipated by Q1 2023
Boston, MA (February 28, 2022) – Aramis Biosciences, Inc., a clinical-stage immuno-ophthalmology biopharmaceutical company, today announced that the first patient has been dosed in its Phase II proof of concept clinical trial evaluating A197, a novel, first-in-class, topical immunomodulatory agent for the treatment of dry eye disease.
“This is an important milestone for Aramis Biosciences and a hopeful moment for dry eye patients given the suboptimal efficacy and tolerability limitations commonly associated with available treatments,” said David S. Tierney, M.D., Aramis Biosciences’ President and CEO. “We are thrilled with the study team assembled for this clinical trial, from our contract research organization to our clinical investigators, and look forward to topline proof of concept data by the first quarter of 2023.”
The Phase II, multicenter, double-masked, randomized, vehicle-controlled, parallel-group clinical trial (NCT05238597) is designed to evaluate the safety and tolerability as well as explore the efficacy of two doses of A197 ophthalmic solution in approximately 200 patients with dry eye disease. The primary endpoint of the trial measures the change from baseline in corneal fluorescein staining with a key secondary endpoint evaluating eye dryness symptoms using the visual analog scale (VAS). The clinical trial will be conducted across approximately 20 centers in the United States.
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 evaluating its lead product candidate, A197, a novel, first-in-class, topical immunomodulatory agent in a 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