Stuart Therapeutics has reported that its first-in-human Phase II clinical trial of its drug candidate, ST-100, in dry eye disease patients met the primary goal.
With a unique mechanism of action, the drug works by reinstating the structural and cell signalling ability of helical collagen damaged by the disease.
The multicentre, controlled, double-masked, randomised trial analysed the acute and chronic efficacy of topical ST-100 eyedrops on dry eye disease signs and symptoms.
Carried out by ophthalmic clinical development company Ora between June and October last year, the trial enrolled a total of 160 subjects who were given a 20mg/ml or 50mg/ml dose of ST-100 twice a day or placebo.
Findings showed that 50mg/ml ST-100 attained the US Food and Drug Administration pre-approved primary endpoint of Schirmer’s Test Responder Rate at 28 days.
A statistically substantial variation between the percentage of subjects attaining a 10mm rise or more in Schirmer’s tear test scores is the Schirmer’s Test Responder Rate.
In order to treat subjects and the treated participant sub-populations, the topical drug candidate was found to offer substantial results in various symptoms, as well as ocular surface staining scores as early as day seven of the therapy.
On day 14 of the therapy, an improvement in overall ocular discomfort (Ora Calibra Scale) was reported.
Furthermore, ST-100 demonstrated to be well tolerated with its comfort scores in line with artificial tear therapies.
No serious treatment-associated side effects were reported in the trial.
Stuart Therapeutics president and CEO Eric Schlumpf 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, PolyCol in additional disease indications.”
A multifactorial ailment of the ocular surface of the eye, dry eye disease is characterised by tear film disruption.
Last December, Aldeyra Therapeutics reported that its 0.25% reproxalap ophthalmic solution (reproxalap) failed to meet the primary goal in the Phase III TRANQUILITY trial for dry eye disease treatment.