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Stuart Therapeutics announces first patient, first visit in its Phase 3 clinical trial of vezocolmitide for dry eye disease
The company announced plans to enroll 320 volunteers in the study. Vezocolmitide is the first drug candidate based on PolyCol, Stuart Therapeutics' patented synthesized polypeptide collagen mimetic peptide platform.
(Image credit: Adobe Stock)
Stuart Therapeutics this week announced the first patient first visit (FPFV) for the company's Phase 3 clinical trial of ST-100 (vezocolmitide), in patients diagnosed with dry eye disease.
According to the company, the Phase 3 multi-center, randomly assigned, double masked, placebo controlled study to assess the safety and efficacy of ST-100 ophthalmic solution in subjects diagnosed with dry eye disease, will evaluate a single dose level versus placebo.
The company said in a news release it will enroll 320 volunteers in the study. Vezocolmitide is the first drug candidate based on PolyCol, the company's patented synthesized polypeptide collagen mimetic peptide platform.
“Since the completion of our Phase 2 trial with ST-100, we have significantly expanded our portfolio, based on new research results on our mechanism of action, and its applicability to a number of important indications in ophthalmology,” Eric Schlumpf, the company’s president and CEO, said in a news release.1
Schlumpf added the company’s findings, coupled with the endpoint outcomes in its Phase 2 trial suggest the potential for a fast acting, highly differentiated treatment for dry eye that can offer improved tear production, symptom relief, reduction in ocular surface damage and improvement in visual acuity.
“We believe that vezocolmitide has the potential to solve the major unmet need for a fast and effective topical therapeutic that treats a broad range of dry eye disease patients,” he added in the release.
According to the company, PolyCol is a platform technology comprised of synthesized polypeptides that mimic key amino acid sequences found in extracellular matrix (ECM) collagen in the body. The mechanism of action is the rapid restoration of disease-damaged helical collagen, resulting in ECM structural repair and restoration of normal cell signaling activity, including reduction in inflammation.1
Moreover, the company added in the release that its pre-clinical research has demonstrated a restoration of the corneal sub-basal nerve plexus, and a beneficial effect on nerve processes and epithelial cells, all of which are implicated in dry eye disease.
According to the news release, Stuart controls the worldwide rights for its PolyCol technology platform in ophthalmology therapeutics.
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