Stuart Therapeutics, Inc. Announces Completion of Patient Enrollment in Phase 2 Clinical Trial for Dry Eye
STUART, Florida, September 8, 2021 / PRNewswire / – Stuart Therapeutics, Inc. (“Stuart“), a clinical-stage biopharmaceutical company conducting research and development of unique peptide therapies for ophthalmic diseases, today announced that it has completed patient enrollment in its Phase 2 clinical trial to assess the efficacy of its drug candidate ST-100, administered topically to Dry Patients with Eye Disease (SOD). United States alone, and 344 million worldwide. It is a multifactorial disease, with a significant unmet need. The multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of ST-100 ophthalmic solution in subjects diagnosed with DED will evaluate two different dose levels compared to placebo. The company recruited 150 volunteers for the study, which is being conducted with the support of that of Stuart strategic partner and CRO, Ora, Inc. ST-100 is based on PolyColMT (PolyCol), the company’s synthesized polypeptide tissue repair platform.
“Today’s announcement of the ‘last patient received’ is an important milestone for our business,” said that of Stuart President and CEO, Eric Schlumpf. “This is another important step in the development of PolyColMT (PolyCol) platform for ophthalmic indications. We are delighted to share this news with our investors and stakeholders. ”
PolyCol is a technology platform comprised of synthesized polypeptides that mimic key amino acid sequences found in the body’s extracellular matrix collagen. They act as a rapid direct repairer of disease-damaged collagen and are applicable when disease or trauma affects vital cells and their underlying structures containing collagen. Based on that of Stuart preclinical research results, PolyCol appears to improve and accelerate the recovery and repair of collagen-dependent cellular structures; and reduce inflammation. Stuart controls the global rights of PolyCol technological platform in ophthalmological therapy.
“We are deeply grateful to the Ora team and the three clinical trial centers who worked diligently to recruit and treat patients in this study, as well as 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, that of Stuart President and Chief Medical Officer.
About the ST-100
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 several in vitro and in vivo preclinical studies to provide rapid healing and reduction of inflammation in eye tissue. ST-100 has the potential to provide rapid relief from the signs and symptoms of dry eye.
About Ora, Inc.
Ora is the global leader in full-service ophthalmic research with offices in United States, UK, Australia, and Asia. For over 40 years, Ora has helped clients achieve 48 product approvals. Ora supports a wide range of organizations, from start-ups to global pharmaceutical and device companies, to effectively bring their new products from concept to market. Ora’s unique global regulatory models, methodologies and strategies have been refined and proven in thousands of global projects. Ora brings together the world’s largest and most experienced team of ophthalmology experts to maximize the value of new product initiatives. For more information visit oraclinical.com.
About Stuart Therapeutics, Inc.
Stuart Therapeutics, Inc. is a clinical-stage biopharmaceutical company engaged in the research and development of unique synthesized peptides as potential therapies for ophthalmic diseases. The company is developing the PolyCol platform for several major indications of chronic eye diseases, including dry eye, glaucoma and age-related macular degeneration.
Contact: Eric Schlumpf, President and Chief Executive Officer, 772-678-7307, [email protected], stuarttherapeutics.com
SOURCE Stuart Therapeutics