Stuart Therapeutics has reported initial findings from its 29-day randomised Phase III trial of the ST-100 (vezocolmitide) ophthalmic solution for treating dry eye disease (DED).
The vehicle-controlled, double-blind trial’s primary endpoint includes a significant increase in the proportion of subjects showing >10mm improvements from baseline in Schirmer’s tear test scores.
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While ST-100’s Schirmer’s Responder Rate (SRR) showed improvement from its Phase II finding, it did not achieve statistical significance, due to the vehicle’s better-than-expected performance.
Despite this, the solution showed statistically significant fluorescein staining improvements in week one in several eye areas of trial subjects, with onset and meaningful improvement observed on day four.
In addition, the company noted that the week one magnitude of stain improvement, compared with the vehicle in the Phase III trial, was greater than the reported outcomes for any DED therapeutic/product currently approved.
ST-100 is derived from the company’s PolyCol technology platform and represents a new class of drugs called collagen mimetic peptides.
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By GlobalDataThe solution targets and repairs damaged collagen, a crucial factor in DED pathophysiology. Damage to collagen can trigger an inflammatory cycle and disrupt tissue integrity, leading to impaired function and cell signalling, particularly in the epithelium of the cornea and the conjunctiva.
The ST-100’s ability to repair ocular collagen helped to restore normal function on the ocular surface, providing relief from DED symptoms.
Stuart Therapeutics CEO and president Eric Schlumpf said: “While additional study is required, the underlying data and the clinically meaningful results from this trial strongly suggest that ST-100, as the first drug candidate in a novel therapeutic class, can address the critical unmet needs in dry eye disease: a fast, effective, and comfortable dry eye topical drop that gives patients rapid relief they can notice and appreciate.”
Stuart is preparing for an additional trial, based on the current Phase III outcomes, and plans to consult with the US Food and Drug Administration (FDA) to confirm the design of the forthcoming trial and clarify the regulatory pathway for ST-100’s approval.
