Key takeaways:
- ST-100 achieved statistically important week 1 enhancements in fluorescein staining and visible operate.
- Stuart Therapeutics is planning to conduct an extra medical trial.
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A section 3 medical trial investigating ST-100 for the therapy of dry eye illness didn’t meet its major endpoint however demonstrated fast-acting therapeutic of the ocular floor, based on a press launch from Stuart Therapeutics.
ST-100 achieved statistically important week 1 enhancements in fluorescein staining and visible operate.
The randomized, double-masked, vehicle-controlled trial investigated ST-100 (vezocolmitide), a collagen mimetic peptide, over 29 days, with the first endpoint being “a big enhance within the proportion of sufferers exhibiting a better than 10 mm enchancment from baseline within the Schirmer’s tear take a look at rating,” the discharge mentioned. Whereas ST-100 confirmed enchancment over its section 2 outcomes in Schirmer’s responder charge, it didn’t obtain statistical significance within the present research, with higher automobile efficiency than in section 2.
Nevertheless, the answer achieved statistically important fluorescein staining enchancment of greater than 20% on day 4. Moreover, it confirmed statistically important visible operate enchancment in contrast with placebo on day 2, based on the discharge.
“The week 1 magnitude of stain enchancment vs. automobile on this section 3 trial was better than any reported consequence for any authorized DED therapeutic or product,” the corporate mentioned within the launch.
Stuart Therapeutics goals to conduct an extra medical trial primarily based on these outcomes.
“Whereas further research is required, the underlying knowledge and the clinically significant outcomes from this trial strongly recommend that ST-100, as the primary drug candidate in a novel therapeutic class, can deal with the crucial unmet wants in dry eye illness: a quick, efficient and comfy dry eye topical drop that provides sufferers fast aid they’ll discover and admire,” Eric Schlumpf, president and CEO of Stuart Therapeutics, mentioned within the launch.
