Stuart Therapeutics’ dry eye disease drug has failed to demonstrate that it can increase tear production in a phase 3 test.
The ophthalmic solution, called ST-100 or vezocolmitide, is a collagen mimetic peptide that is designed to repair disease-damaged collagen and improve cell health. ST-100 failed to demonstrate a significant rise in the proportion of patients who saw a more than 10mm increase in tear production after 29 days when compared to vehicle, missing the study’s primary endpoint.
The rate of tear production was still higher than seen in ST-100’s successful phase 2 study in 2022, but it didn’t reach statistical significance in today's phase 3 readout due to a better performance in the vehicle cohort, Stuart noted in the June 24 release.
The Stuart, Florida-based company pointed to the trial’s secondary endpoints, where it claimed ST-100 had demonstrated “industry-leading results.” This included a clinically meaningful improvement in fluorescein staining—a way to examine eye damage—on Day 4, as well as a statistically significant improvement in vision relative to placebo on Day 2.
Despite the primary endpoint miss, Stuart’s CEO Eric Schlumpf insisted that he was “very pleased” with the trial’s outcome. The biotech is now planning to get the FDA’s feedback for the design of a further phase 3 study that could keep ST-100 in with a shot at approval.
“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,” Schlumpf added.
ST-100 was developed with Stuart’s synthesized polypeptide therapeutic platform, which is designed to heal specific areas of collagen damage involved in chronic diseases of the eye. Glaukos has picked up the rights for another asset produced by this platform in the form of Stuart's glaucoma candidate ST-113.