SilkTech completes enrollment in trial of biological dry eye treatment candidate
SilkTech Biopharmaceuticals has completed enrollment in a phase 2b clinical trial of SDP-4, its eye drop formulation for the treatment of the signs and symptoms of dry eye disease, according to a press release.
The randomized, double-masked, vehicle-controlled, multicenter trial is evaluating the safety and efficacy of SDP-4 at 0.1%, 1% and 3% concentrations in 305 patients at 25 U.S. sites.
SDP-4, a biotherapeutic naturally derived from silk protein, is designed to utilize a dual mechanism of action to physically improve tear film stability and reduce inflammation to treat dry eye. It also inhibits kinase activation of the NF-kB gene transcription pathway.
“Our team has accomplished a significant milestone in reaching full enrollment of our first-in-human ophthalmic study for a silk protein-derived biotherapeutic,” Brian Lawrence, PhD, SilkTech CEO, said in the release. “The trial enrolled 6 weeks ahead of projected schedule indicating the significant and growing need for new therapeutic approaches to this debilitating disease.”
Topline data are expected to be reported by the end of this year’s fourth quarter.