Stuart Therapeutics, Inc. (“Stuart“), a clinical stage biopharmaceutical company conducting research and development of unique peptide therapeutics for ophthalmic diseases, today announced that it has completed patient enrollment in its Phase 2 clinical trial to evaluate the efficacy of its drug candidate ST-100, administered topically to Dry Eye Disease (DED) patients. DED is a common indication affecting 20 million people in the United States alone, and 344 million worldwide.
It is a multifactorial disease, with a significant unmet need. The multi-center, randomized, double masked, placebo-controlled study, assessing the safety and efficacy of ST-100 ophthalmic solution in subjects diagnosed with DED, will evaluate two different dose levels versus placebo. The company has enrolled 150 volunteers in the study, which is being conducted with the support of Stuart’sstrategic partner and CRO, Ora, Inc. ST-100 is based on PolyColTM (PolyCol), the company’s synthesized polypeptide tissue reparative platform.
“Today’s ‘Last-Patient-In’ announcement is a major milestone for our company,” said Stuart’s President and CEO, Eric Schlumpf. “This is another important step in the development of the PolyColTM (PolyCol) platform for ophthalmic indications. We are pleased to share this news with our investors and stakeholders.”
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 PolyColtechnology platform in ophthalmology therapeutics.
“We are deeply grateful to the team at Ora, and the three clinical trial centers that have worked diligently to enroll and treat patients in this study, and to our three investigators, Drs. Torkildsen, Jordan, and Evans. We also thank our participating patients for their commitment of time and energy to this study,” said Bob Baratta, MD, Stuart’sChairman and Chief Medical Officer.
ST-100 is a topically administered drop formulation based on the PolyCol family of collagen mimetic peptides. These peptides are designed to repair damaged collagen in disease-affected tissues, and to restore normal cell signaling behavior. PolyCol has been shown in multiple in vitro and in vivo pre-clinical studies to provide rapid healing and reduction in inflammation in ocular tissues. ST-100 has the potential to offer rapid relief from both signs and symptoms of dry eye disease.