The late-stage multi-centre, randomised, double-masked, placebo-controlled trial will evaluate the safety and effectiveness of ST-100 ophthalmic solution in patients with dry eye disease
ST-100 is based on Stuart’s proprietary synthetic polypeptide collagen mimetic peptide platform. (Credit: Marc Schulte on Unsplash)
US-based biopharmaceutical company Stuart Therapeutics has reported the First Patient First Visit (FPFV) for its Phase 3 clinical trial of ST-100 (vezocolmitide) in dry eye disease patients.
ST-100 is said to be the first drug candidate based on PolyCol, Stuart’s proprietary synthetic polypeptide collagen mimetic peptide platform.
The late-stage multi-centre, randomised, double-masked, placebo-controlled trial will evaluate the safety and effectiveness of ST-100 ophthalmic solution in patients with dry eye disease.
In the study, Stuart Therapeutics will enrol 320 volunteers to assess a single dose level against a placebo.
Stuart Therapeutics president and CEO Eric Schlumpf said: “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.
“In particular, our findings, coupled with the endpoint outcomes in our 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.”
According to Stuart Therapeutics, the PolyCol platform is made up of synthesised polypeptides that are designed to resemble important amino acid sequences present in the extracellular matrix (ECM) collagen in the body.
The technology enables quick restoration of disease-damaged helical collagen, resulting in ECM structural repair and restoration of normal cell signalling activity, which in turn reduces inflammation.
The biopharmaceutical firm said that the preclinical studies have demonstrated favourable effects on neural processes and epithelial cells, as well as repair of the corneal sub-basal nerve plexus.
Stuart Therapeutics oversees the global rights for the PolyCol technology platform in ophthalmology therapeutics.
In October last year, the company granted global rights to Glaukos to develop and commercialise its proprietary ST-113 drug candidate for neuroprotection in glaucoma.