Stuart Therapeutics, Inc. Announces Successful Phase 2 Clinical Trial Results of its Novel Dry Eye C

Stuart Therapeutics, Inc. Announces Successful Phase 2 Clinical Trial Results of its Novel Dry Eye Candidate ST-100

- Achieved FDA Pre-Approved Single Primary Endpoint After 28 Days of Administration

- Improvement in Total Ocular Discomfort after 14 Days

STUART, Fla., Jan. 3, 2022 /PRNewswire/ -- Stuart Therapeutics, Inc. (STUART), a clinical stage, innovative ophthalmic therapeutic development company, today announced the topline results of the first in human Phase 2 clinical trial for its lead drug candidate, ST-100 in patients with dry eye disease. The clinical trial, conducted between June and October 2021, was a multi-center, randomized, controlled, double masked clinical trial to evaluate the acute and chronic efficacy of topical ST-100 eyedrops on the signs and symptoms of dry eye disease.  One hundred and sixty patients were enrolled, and received twice daily dosing of either 20mg/ml or 50mg/ml of ST-100, or placebo.

ST-100 (50mg/ml) achieved a pre-approved, based on recent FDA guidance, primary endpoint – Schirmer's Test Responder Rate (defined as a statistically significant difference between the percentage of patients achieving a 10mm increase or more in Schirmer's tear test scores) at 28 days (p=0.0266).  ST-100 also demonstrated significant results in several symptoms and ocular surface staining scores as early as treatment day seven in both the intent to treat population, as well as the treated patient sub-populations.  Overall Ocular Discomfort (Ora Calibra Scale) improvement was observed at treatment day 14 (p=0.0332).  

ST-100 was well tolerated, and comfort scores for the eyedrops compare favorably with artificial tear products.  There were no observed serious drug-related adverse events associated with the trial.  The Phase 2 trial was conducted by Ora^®, Inc., a leading ophthalmic clinical development firm.

"It is encouraging that ST-100 met the challenging Schirmer's Responder Rate endpoint in just 28 days.  Based on STUART's other studies of the mechanism of action (see below), it has the potential to directly affect the neural process integrity of the cornea and conjunctiva which is considered an underlying cause of dry eye, impacting ocular surface health and tear film production.  The efficacy and comfort profile of ST-100 suggest the possibility for a breakthrough treatment for dry eye, a debilitating disease that affects over 700 million patients worldwide," said George Ousler, Senior Vice President for Ora. "Ora is honored to partner with Stuart Therapeutics to evaluate this promising candidate, and we look forward to seeing this therapy advance to the next stage in clinical development."

"The Stuart Therapeutics team is proud to have accomplished this important milestone," said Eric Schlumpf, President & Chief Executive Officer. "The Phase 2 trial has provided us with an important understanding of the efficacy and tolerability of ST-100 as a topical ophthalmic therapeutic, and provided us with a wealth of human data to further explore the details of the mechanism of action and the potential for ST-100 and our collagen mimetic platform technology, PolyCol^TM (PolyCol) in additional disease indications."

"As a long-time practicing ophthalmologist, I am pleased at the speed of the onset of action, comfort of the ST-100 formulation, and efficacy outcomes," said Robert Baratta, MD, Chief Medical Officer and Chairman of STUART. "We are excited about the opportunity to move ST-100 forward into the Phase 3 program."

About ST-100

ST-100's unique Mechanism of Action (MOA) acts by restoring structural and cell signaling capability of disease damaged helical collagen . Pre-clinical results have demonstrated epithelial restoration, and neuronal protection, repair and regeneration in in vitro and in vivo models.  The current Phase 2 clinical trial results appear to support the neuronal pathway for tear production, and ST-100's role in repairing DED-damaged nerve pathways in the conjunctiva and cornea.

About PolyCol

ST-100's active ingredient is part of the PolyCol platform of synthesized collagen mimetic peptides.  STUART controls the worldwide rights for this patented technology in ophthalmology therapeutics.  The active ingredient in ST-100 is a stable fractional synthetic single strand of human collagen.  It acts as a direct reparative to damaged helical collagen in situ, and is directly applicable where disease or trauma impacts important cells and the underlying collagen membranes and extracellular matrix. 

About Dry Eye Disease

An estimated 16 million U.S. adults have been diagnosed with Dry Eye Disease, a multifactorial condition of the ocular surface of the eye, characterized by disruption of the tear film.  A healthy tear film protects and lubricates the eyes, washes away foreign particles, contains antimicrobials to reduce the risk of infection, and creates a smooth surface which contributes refractive power for clear vision. Dry Eye Disease can have a significant impact on a person's day-to-day quality of life, as it can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision, and eye fatigue. Despite the large prevalence of dry eye and the burden of the disease, there remains a significant unmet need for effective therapies.

About Ora^®, Inc.

Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 40 years, we have proudly helped our clients earn more than 45 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 pre-clinical and clinical models, unique 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, R&D professionals, and management executives to maximize the value of new product initiatives. For more information, please visit www.oraclinical.com

About Stuart Therapeutics, Inc. 

Stuart Therapeutics' mission is to offer unique solutions for difficult-to-treat eye diseases. STUART is focused on the research and development of ophthalmic therapeutic products based on the company's proprietary PolyCol Collagen Mimetic Peptide (CMP) platform. STUART's first CMP drug in development is ST-100, targeting Dry Eye Disease. ST-100 is expected to be broadly applicable to the patient population and should have therapeutic applications in patients regardless of the underlying cause of their dry eye disease. Stuart continues to focus on global expansion and the development of additional product candidates and technologies in ophthalmology, including for the treatment of glaucoma and dry age-related macular degeneration,.

For more information, please visit www.StuartTherapeutics.com.

Media contact:

Eric Schlumpf

206-228-2781

[email protected]

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SOURCE Stuart Therapeutics