Stuart Therapeutics Announces Start of Patient Enrollment in its Phase 2 Clinical Trial of ST-100 for Dry Eye Disease

STUART, Fla., June 11, 2021 /PRNewswire/ -- Stuart Therapeutics, Inc. ("Stuart"), a clinical stage biopharmaceutical company conducting research and development of unique peptide therapeutics for ophthalmic diseases, today announced the start of patient enrollment for the company's Phase 2 study of ST-100, in Dry Eye Eisease patients. The Phase 2 multi-center, randomized, 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 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^TM (PolyCol), the company's synthesized polypeptide tissue reparative platform.

"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," stated George Ousler, Ora's Senior Vice President, Anterior Segment.

"Today's announcement represents a significant milestone in the development of the PolyCol platform," said Eric Schlumpf, President & CEO of Stuart. "We are thrilled to have the opportunity to explore what ST-100 can do in patients in our Phase 2 trial.  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 Disease patients."

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 PolyCol technology platform in ophthalmology therapeutics.

Robert Baratta, MD, Stuart's Chief Medical Officer and Chairman, said, "The start of enrollment for our Phase 2 trial for ST-100 is an exciting moment for our company, and 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.  We look forward to the results of our trial."

About Ora, Inc.
Ora is the world's leading full-service ophthalmic research organization with offices in the United States, United Kingdom, Australia, and Asia. For over 40 years, we have helped our clients earn 48 product approvals. We support a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently bring their new products from concept to market. Ora's unique models, methodologies, and global regulatory strategies have been refined and proven across thousands of global projects. We bring together the world's most extensive and experienced team of ophthalmic experts to maximize the value of new product initiatives. For more information, please visit oraclinical.com.

About Stuart Therapeutics, Inc.
Stuart Therapeutics, Inc. is a clinical-stage biopharmaceutical company conducting research and development of unique synthesized peptides as potential therapeutics for ophthalmic diseases.  The company is developing the PolyCol platform for several major chronic eye disease indications.

Contact:  Eric Schlumpf, President & CEO, 772-678-7307, [email protected], stuarttherapeutics.com.

SOURCE Stuart Therapeutics