Enrollment underway in phase 2 study of subcutaneous anti-VEGF wet AMD, DME candidate
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The first patient has been enrolled in a two-stage phase 2 study of D-4517.2 for the treatment of wet age-related macular degeneration or diabetic macular edema, according to a press release from Ashvattha Therapeutics.
The clinical study will evaluate the safety and efficacy of the subcutaneously administered treatment candidate, a hydroxyl dendrimer therapeutic with potent anti-VEGF activity, at different dose levels compared with intravitreal aflibercept.
The first stage of the study will include 30 participants with wet AMD or DME who will be monitored for adverse events for up to 12 weeks after drug administration. The double-masked, sham- and placebo-controlled, noninferiority second stage of the study will evaluate efficacy of the different dose levels for up to 9 months in wet AMD.
“A subcutaneously administered treatment offers an at-home option that patients can administer themselves,” Jeffrey Cleland, PhD, chairman, CEO and president of Ashvattha Therapeutics, said in the release. “We are proceeding into phase 2 based on positive results from our phase 1 study in healthy subjects that we presented at ARVO demonstrating D-4517.2 has an exceptional safety and tolerability profile at varying dose levels and has been efficacious in animal models of choroidal neovascular disease.”
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