US-based biopharmaceutical company Stuart Therapeutics has begun a Phase III clinical trial of the drug candidate vezocolmitide (ST-100) to treat patients with dry eye disease.
The randomised, placebo-controlled trial aims to evaluate the efficacy and safety of one dose of the ophthalmic solution compared with a placebo. It will enrol 320 subjects.
Vezocolmitide is based on the company’s patented synthesised polypeptide collagen mimetic peptide platform, PolyCol.
It is designed to repair disease-damaged collagen, potentially reducing inflammation and restoring normal cell function.
The PolyCol technology consists of synthesised polypeptides that replicate essential amino acid sequences seen in extracellular matrix (ECM) collagen.
The approach can rapidly reinstate helical collagen impacted by the disease, leading to structural repair of the ECM and normalisation of cell signalling, including inflammation reduction.
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In pre-clinical research, it was observed that vezocolmitide offered a restoration of the corneal sub-basal nerve plexus and a beneficial effect on nerve processes and epithelial cells. All of these are implicated in dry eye disease.
Stuart Therapeutics holds the worldwide rights for the PolyCol technology platform in the ophthalmology therapeutics sector.
Stuart Therapeutics president and CEO Eric Schlumpf said: “Since the completion of our Phase II 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.
“In particular, our findings, coupled with the endpoint outcomes in our Phase II 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.”