Stuart Therapeutics, Inc. announced the launch of its phase 3 trial on vezocolmitide—a potential dry eye disease (DED) treatment—with the first patient first visit (FPFV).
Let’s start with the company.
Founded in 2017 and based in Stuart, Florida, the clinical-stage biopharmaceutical company is working to address chronic ocular disease indications, including:
- Dry eye disease (DED)
- Glaucoma
- Age-related macular degeneration (AMD)
Currently under development is a synthesized polypeptide therapeutic called PolyCol.
And PolyCol is…
The therapeutic platform tackles specific areas of collagen damage that can be affected in chronic eye diseases with the added benefit to potentially heal these ocular tissues.
It operates as a direct tissue reparative for extracellular matrix (ECM) helical collagen membranes and structures in the eye—effectively the first technology to target damaged collagen in eye diseases.
PolyCol is specifically designed to bind or intercalate into the key damaged areas of cellular tissue, “restoring cell signaling and the structural role collagen plays in healthy tissues,” for diseases such as
- DED (ST-100… we’ll get to that in a moment)
- Glaucoma (ST-113)
- AMD (ST-109)
Per Stuart, quick work, rapid restoration of tissue health, and reduced inflammation are the key metrics.
Gotcha. Now talk about ST-100.
ST-100 (vezocolmitide)— the company’s first candidate based on the PolyCol platform—is formulated as an eye drop with the intended effect of providing rapid improvement in DED signs and symptoms.
What did previous clinical data find?
Back in January 2022, the company reported positive topline data from a multicenter, double-masked, randomized first-in-human (FIH) phase 2 study (NCT05241470) that evaluated ST-100 in two doses (20 mg/mL [low] and 50 mg/mL [high]) against a placebo.
ST-100 met its pre-approved primary endpoint of achieving a statistically significant difference between the percentage of patients achieving a +10 mm in Schirmer’s tear test score at 28 days (p = 0.0266).
The formulation also demonstrated significant results in several symptom and ocular surface staining scores as early as Day 7 of treatment. See here for more details.
And this phase 3 trial?
The multicenter, randomized, double-masked placebo-controlled study (NCT06178679) is evaluating the safety and efficacy of ST-100 ophthalmic solution in 320 participants (aged 18+) diagnosed with DED.
Patient criteria can be found here.
And the dosings?
A single dose level of ST-100 will be compared against a placebo:
- ST-100 (vezocolmitide) ophthalmic solution 60 μg/mL
- Dosed bilaterally twice daily for 7 weeks (49 days)
- Vehicle ophthalmic solution
- Dosed bilaterally twice daily for 7 weeks (49 days)
What’s being measured?
The primary outcome measure is comparing the efficacy of ST-100 against vehicle using the Schirmer’s test, as measured by the number of participants with ≥ 10mm improvement from baseline at Day 29.
A total of nine secondary and 10 other outcome measures can be viewed here.
And the significance?
Based on phase 2 data, Stuart President and CEO Eric Schlumpf shared the company’s belief that ST-100 has the potential to solve a significant unmet need in DED treatment—with this upcoming phase 3 data a major milestone in its quest for regulatory approval.“
Our findings, coupled with the endpoint outcomes in our phase 2 trial suggest the potential for a fast acting, highly differentiated treatment for dry eye that can offer improved tear production, symptom relief, reduction in ocular surface damage and improvement in visual acuity,” he stated.
When can we expect results?
Per Clinical Trials, the study is slated to conclude by July 2024.