Stuart Therapeutics, a clinical stage, ophthalmic therapeutic development company, has announced the topline results of the first in human Phase II clinical trial for its lead drug candidate, ST-100 in patients with dry eye disease.
The clinical trial, conducted between June and October 2021, was a multi-centre, randomised, controlled, double masked clinical trial to evaluate the acute and chronic efficacy of topical ST-100 eyedrops on the signs and symptoms of dry eye disease. One hundred and sixty patients were enrolled, and received twice daily dosing of either 20mg/ml or 50mg/ml of ST-100, or placebo.
ST-100 (50mg/ml) achieved a pre-approved, based on recent FDA guidance, primary endpoint – Schirmer’s Test Responder Rate (defined as a statistically significant difference between the percentage of patients achieving a 10mm increase or more in Schirmer’s tear test scores) at 28 days (p=0.0266).
ST-100 also demonstrated significant results in several symptoms and ocular surface staining scores as early as treatment day seven in both the intent to treat population, as well as the treated patient sub-populations. Overall Ocular Discomfort (Ora Calibra Scale) improvement was observed at treatment day 14 (p=0.0332).
ST-100 was well tolerated, and comfort scores for the eyedrops compared favourably with artificial tear products. There were no observed serious drug-related adverse events associated with the trial. The Phase II trial was conducted by Ora, a ophthalmic clinical development firm.
“It is encouraging that ST-100 met the challenging Schirmer’s Responder Rate endpoint in just 28 days. Based on Stuart’s other studies of the mechanism of action, it has the potential to directly affect the neural process integrity of the cornea and conjunctiva which is considered an underlying cause of dry eye, impacting ocular surface health and tear film production. The efficacy and comfort profile of ST-100 suggest the possibility for a breakthrough treatment for dry eye, a debilitating disease that affects over 700 million patients worldwide,” said George Ousler, Senior Vice President for Ora. “Ora is honoured to partner with Stuart Therapeutics to evaluate this promising candidate, and we look forward to seeing this therapy advance to the next stage in clinical development.”
Eric Schlumpf, President & Chief Executive Officer, said: “The Phase II trial has provided us with an important understanding of the efficacy and tolerability of ST-100 as a topical ophthalmic therapeutic, and provided us with a wealth of human data to further explore the details of the mechanism of action and the potential for ST-100 and our collagen mimetic platform technology, PolyColTM (PolyCol) in additional disease indications.”
“As a long-time practicing ophthalmologist, I am pleased at the speed of the onset of action, comfort of the ST-100 formulation, and efficacy outcomes,” said Robert Baratta, MD, Chief Medical Officer and Chairman of Stuart. “We are excited about the opportunity to move ST-100 forward into the Phase III programme.”