Stuart Therapeutics gives Initial Results of Phase III Clinical Trial for ST-100 Ophthalmic Solution

Overview

Stuart Therapeutics, Inc., a clinical-stage drug platform company developing novel therapies for ophthalmic diseases, today announced the initial results of its Phase III clinical trial evaluating ST-100 (vezocolmitide) ophthalmic solution for the treatment of Dry Eye Disease (DED), which affects more than 30 million U.S. adults.

About the randomized trial

• The 29-day randomized, double-blind, vehicle-controlled trial assessed a variety of endpoints, including a primary endpoint of a significant increase in the proportion of patients exhibiting a greater than 10mm improvement from baseline in the Schirmer's tear test score (the Schirmer's Responder Rate, or SRR). 
• ST-100's SRR performance exceeded that of its Phase II outcome2 but did not reach statistical significance, as vehicle performed better than in the Phase II trial.

On several additional important endpoints commonly used to evaluate DED, ST-100 demonstrated industry leading results. ST-100 achieved statistically significant Week 1 fluorescein staining improvement in multiple regions of the eyes of trial subjects, with onset and clinically meaningful (>20%) improvement on Day 4. The Week 1 magnitude of stain improvement vs. vehicle in this Phase III trial was greater than any reported result for any approved DED therapeutic or product. Statistically significant visual function improvement relative to placebo was achieved on Day 2, further reinforcing ST-100's potential to provide fast-acting resolution of dry eye signs and symptoms.  

Comments from the CEO: Stuart Therapeutics

• We are very pleased with the outcome of the trial,"" said Stuart Therapeutics President and CEO Eric Schlumpf. 
• While additional study is required, the underlying data and the clinically meaningful results from this trial strongly suggest that ST-100, as the first drug candidate in a novel therapeutic class, can address the critical unmet needs in dry eye disease: a fast, effective, and comfortable dry eye topical drop that gives patients rapid relief they can notice and appreciate.""

The collagen mimetic peptides: ST-100

• ST-100 is part of a novel drug class of collagen mimetic peptides derived from the company's patented and proprietary PolyCol™ technology platform, which have a unique mechanism of action. 
• Unlike other DED therapeutics, ST-100 works by targeting and repairing damaged collagen. 
• Collagen plays a key role in DED, and collagen damage during the development of DED is part of an inflammatory cycle and loss of tissue integrity that interferes with normal function and cell signaling, particularly in the epithelium of the cornea and conjunctiva. 
• ST-100's ability to repair this ocular collagen restores homeostatic function on the ocular surface, thereby alleviating the effects of DED.

Statement from the CMO: Stuart Therapeutic

• As a practicing ophthalmologist, I am impressed by the clinical achievements and speed of onset of the therapeutic effects of ST-100 in Stuart's Phase III trial, which suggest rapid ocular surface healing and treatment effects that appear to be considerably greater than those seen with currently approved dry eye disease therapeutics,"" said Jodi Luchs, MD, Stuart Therapeutics chief medical officer. 
• Based on these study results, I believe ST-100 has the potential to greatly enhance the treatment of dry eye disease and has significant promise in treating other debilitating diseases affecting the cornea.""

Further plans

•  Stuart Therapeutics is finalizing a plan for an additional clinical trial using the results from the present Phase III trial to help guide the trial design. 
• The Company also intends to engage with the U.S. Food and Drug Administration (FDA) to confirm the design of this additional trial, and the regulatory path to approval of ST-100.

About Dry Eye Disease

Dry Eye Disease (DED) is a multifactorial ocular disorder suffered by millions of patients worldwide which involves ocular surface damage, inflammation, and damage to corneal nerves, resulting in patient discomfort, blurred vision, and difficulty with activities of daily life.

About ST-100 (Vezocolmitide)

• ST-100 is a patented formulation of vezocolmitide, a collagen mimetic peptide that selectively repairs disease-damaged collagen in the eye. 
• This repair of the ocular collagen matrix restores homeostatic cell signaling, particularly in the ocular epithelium. 
• In its preclinical research, Stuart Therapeutics showed that collagen memetic peptides induce improvements in cell health and function in epithelial, neuronal and endothelial cells and tissues containing such cells,3-6 and reductions in inflammation and oxidative stress. 
• These factors are critical in DED and other ophthalmic indications.

About Stuart Therapeutics, Inc.

• Headquartered in Stuart, Florida, Stuart Therapeutics, Inc. is a clinical-stage drug platform company addressing DED, Glaucoma, Myopia and Retinal Diseases, such as Diabetic Retinopathy. 
• The company is the leader in the research and development of therapeutics targeting the ocular extracellular matrix.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!