Stuart Therapeutics, Inc. Announces Successful Results of Phase 2 Clinical Trial of New Dry Eye Candidate ST-100
STUART, Florida, January 3, 2022 / PRNewswire / – Stuart Therapeutics, Inc. (STUART), an innovative clinical-phase ophthalmic therapy development company, today announced the first results of the first phase 2 human 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 multicenter, randomized, controlled, double-blind clinical trial to evaluate the acute and chronic efficacy of ST-100 topical eye drops on the signs and symptoms of dry eye. One hundred and sixty patients were included and received twice daily a dose of 20 mg / ml or 50 mg / ml of ST-100, or a placebo.
FDA pre-approved single primary endpoint met after 28 days & Improvement in total eye discomfort after 14 days
ST-100 (50 mg / ml) met a pre-approved primary endpoint, based on recent FDA guidelines, Schirmer’s test response rate (defined as a statistically significant difference between the percentage of patients reaching an increase of 10 mm 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 of the seventh day of treatment in both the intention-to-treat population as well as in the treated patient subpopulations. An overall improvement in ocular discomfort (Ora Calibra scale) was observed on day 14 of treatment (p = 0.0332).
ST-100 was well tolerated and the comfort scores of eye drops compared favorably to artificial tear products. There were no serious drug-related adverse events associated with the trial. The phase 2 trial was conducted by Ora®, Inc., a leading ophthalmic clinical development company.
“It is encouraging that the ST-100 achieved Schirmer’s difficult endpoint of response rate in just 28 days. STUART further studies on the mechanism of action (see below), it has the potential to directly affect the integrity of the neural process of the cornea and conjunctiva, which is believed to be an underlying cause of dry eye, impacting the health of the ocular surface and tear film production. The efficacy and comfort profile of ST-100 suggests the possibility of a revolutionary treatment for dry eye, a debilitating disease that affects more than 700 million patients worldwide, ”said Georges Ousler, first vice-president of Ora. “Ora is honored to partner with Stuart Therapeutics to assess this promising candidate, and we look forward to seeing this therapy move to the next stage in clinical development. “
“The Stuart Therapeutics team is proud to have taken this important step,” said Eric Schlumpf, President and CEO. “The Phase 2 trial gave us a better understanding of the efficacy and tolerability of ST-100 as a topical ophthalmic treatment, and provided us with a wealth of human data to further explore the details of the mechanism of action and the potential of ST-100 and our collagen mimetic platform technology, PolyColMT (PolyCol) in other indications of disease. “
“As a long-time ophthalmologist, I am satisfied with the speed of action, the comfort of the ST-100 formulation and the efficacy results,” said Robert baratta, MD, Chief Medical Officer and President of STUART. “We are delighted with the opportunity to advance the ST-100 into the Phase 3 program.”
About the ST-100
ST-100’s unique mechanism of action (MOA) works by restoring the structural and cellular signaling capacity of helical collagen damaged by disease. Preclinical results demonstrated epithelial restoration and neuronal protection, repair and regeneration in in vitro and in vivo models. Current results from the Phase 2 clinical trial appear to support the neural pathway for tear production and the role of ST-100 in repairing DED-damaged nerve pathways in the conjunctiva and cornea.
The active ingredient in ST-100 is part of the PolyCol platform of synthesized collagen mimetic peptides. STUART controls the worldwide rights to this patented technology in ophthalmic therapy. The active ingredient in ST-100 is a stable split synthetic single strand of human collagen. It acts as a direct repairer of damaged helical collagen in situ, and is directly applicable when disease or trauma affects important cells and the underlying collagen membranes and extracellular matrix.
About dry eye
An estimated 16 million American adults have been diagnosed with dry eye, a multifactorial condition of the ocular surface of the eye characterized by a rupture of the tear film. A healthy tear film protects and lubricates the eyes, removes foreign particles, contains antimicrobials to reduce the risk of infection, and creates a smooth surface that contributes refractive power for clear vision. Dry eye can have a significant impact on a person’s quality of daily life, as it can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision, and eye strain. Despite the high prevalence of dry eye and the burden of disease, there remains a significant unmet need for effective therapies.
About Ora®, Inc.
Ora is the global leader in the development of full-service ophthalmic drugs and devices with offices in United States, UK, Australia, and Asia. For over 40 years, we have proudly helped our customers achieve over 45 product approvals. We support 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 preclinical and clinical models, unique methodologies and global regulatory strategies have been refined and proven in thousands of global projects. We bring together the world’s largest and most experienced team of ophthalmology experts, R&D professionals and senior 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 provide unique solutions for difficult-to-treat eye diseases. STUART focuses on the research and development of ophthalmic therapeutics based on the PolyCol Collagen Mimetic Peptide (CMP) platform. STUART The first CMP drug in development is ST-100, targeting dry eye disease. ST-100 is expected to be widely applicable to the patient population and is expected to 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, particularly for the treatment of glaucoma and age-related dry macular degeneration.
For more information, please visit www.StuartTherapeutics.com.
SOURCE Stuart Therapeutics