Stuart Therapeutics begins patient enrollment in Phase 2 study of dry eye disease therapeutic option

Stuart Therapeutics Inc. today announced the start of patient enrollment for the company's Phase 2 study of ST-100, in dry eye disease patients.

The Phase 2 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 two different dose levels versus placebo.

The company, a clinical stage biopharmaceutical company conducting research and development of unique peptide therapeutics for ophthalmic diseases, will enroll 150 volunteers in the study, which is being conducted with the support of Stuart's strategic partner and CRO, Ora Clinical. ST-100 is based on PolyCol, the company's synthesized polypeptide tissue reparative platform.

George Ousler, Ora's senior vice president, Anterior Segment, noted in a statement that ST-100's novel mechanism of action has the potential to rapidly address both signs and symptoms of dry eye disease across several patient subtypes, currently suffering from this debilitating condition.

“We look forward to working with Stuart Therapeutics to conduct this comprehensive first in human study that evaluates safety and efficacy endpoints over a 28-day treatment period,” he added.

Eric Schlumpf, president and CEO of Stuart, pointed out that the announcement represents a significant milestone in the development of the PolyCol platform.

“We are thrilled to have the opportunity to explore what ST-100 can do in patients in our Phase 2 trial,” he said in a statement. “We believe PolyCol, a next generation tissue reparative technology, has the potential to solve the major unmet need for a fast and effective topical therapeutic that treats a broad range of dry eye Ddsease patients.”

According to the company, PolyCol is a platform technology comprised of synthesized polypeptides that mimic key amino acid sequences found in extra-cellular matrix collagen in the body.

They act as a rapid direct reparative to disease damaged collagen and are applicable where disease or trauma impacts vital cells and their underlying collagen-containing structures. Based on Stuart's pre-clinical research results, PolyCol appears to improve and accelerate the recovery and repair of the cellular structures dependent upon collagen and reduce inflammation. 

Stuart controls the worldwide rights for the technology platform in ophthalmology therapeutics.

Robert Baratta, MD, Stuart's chief medical officer and chairman, noted that the initial enrollment for the Phase 2 trial for ST-100 is a milestone for the company.

“We appreciate the contributions of our partners and the Stuart team, as well as the clinical investigators and the patient volunteers, to bring us here,” he concluded. “We look forward to the results of our trial."