UncategorizedStuart Therapeutics Announces Receipt of Study May Proceed Letter from U.S. FDA for ST-100 Dry Eye Disease Phase 2 Clinical Trial

March 19, 2021

Stuart Therapeutics Announces Receipt of Study May Proceed Letter from U.S. FDA for ST-100 Dry Eye Disease Phase 2 Clinical Trial

Stuart Therapeutics (Stuart) announced today that the U.S. Food and Drug Administration (FDA) has completed its review of an Investigational New Drug (IND) application for Stuart’s investigational product ST-100, a topical drop formulation designed to treat ocular surface diseases, including dry eye disease, an indication that affects nearly 10% of the United States population. As a result of this review, the FDA has issued a No-Holds, Study May Proceed letter to Stuart, permitting the company to begin its Phase 2 clinical trial on ST-100.

Stuart is sponsoring the Phase 2 trial on ST-100, a drug candidate whose active ingredient is part of the PolyColTM (PolyCol) synthesized polypeptide platform. Stuart owns the exclusive worldwide rights to PolyCol for ophthalmic therapeutic use. The ST-100 Phase 2 trial, expected to begin before the end of the second quarter of this year, is a double-blind, multi-center trial, with two primary, and several secondary endpoints. The company expects to receive a full readout on the trial at or before the end of the third quarter 2021.

“We are very pleased that Stuart’s first IND has been favorably reviewed with no clinical holds or modifications”, said Robert Baratta, MD, Chief Medical Officer of Stuart. “Our Phase 2 study design provides us the opportunity to gain important insights about the effectiveness of ST-100 for a wide range of dry eye disease symptoms and signs.”

“We are excited about this major milestone for Stuart Therapeutics, and the chance to demonstrate the capabilities of the PolyCol platform,” said Eric Schlumpf, President & CEO of Stuart. “We are looking forward to successful execution of our Phase 2 trial and the ability to help patients that suffer from chronic ocular surface disease.”

About ST-100

ST-100 is a drop formulation based on the PolyCol family of collagen mimetic peptides. These peptides are designed to repair damaged collagen in disease-affected tissues, and to restore normal cell signaling behavior. PolyCol has been shown in numerous in vitro and in vivo pre-clinical studies to provide rapid healing and reduction in inflammation in ocular tissues. ST-100 has the potential to offer rapid relief from both signs and symptoms of dry eye disease, an indication with significant unmet need.

About Stuart Therapeutics, Inc.

Stuart Therapeutics, Inc. is a clinical-stage biopharmaceutical company conducting research and development of unique synthesized peptides as potential therapeutics for ophthalmic diseases. The company is focused on ocular surface diseases, neuroprotection for glaucoma, and age-related macular degeneration.

Contact: Eric Schlumpf, President & CEO, 772-678-7307, [email protected], https://www.stuarttherapeutics.com