Ashvattha Therapeutics Announces First Patient Enrolled in a Phase 2 Study of D-4517.2 for the Treatment of Wet AMD and DME

– First patient was enrolled as part of a two-stage Phase 2 study evaluating Ashvattha’s subcutaneous (SC) anti-VEGF wet AMD and DME candidate, D-4517.2 –

– The first stage of the study will evaluate the safety and relative pharmacodynamic effect of different doses of subcutaneously (SC) administered D-4517.2 compared to intravitreal (IVT) injection of aflibercept, an approved therapy, in both wet AMD and DME patients up to 12 weeks –

– The second stage of the study will compare the relative efficacy of two dose regimens of D-4517.2 to IVT aflibercept in wet AMD patients up to 9 months –

Excerpt from the Press Release:

REDWOOD CITY, Calif., Sept. 07, 2022 (GLOBE NEWSWIRE) — Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company developing novel hydroxyl dendrimer therapeutics (HDT), today announced that the first patient has been enrolled in a two-stage Phase 2 clinical study of D-4517.2, an HDT with potent anti-VEGF activity. This study aims to evaluate the safety and efficacy of a subcutaneous (SC) injection of D-4517.2 at different dose levels in comparison to intravitreal (IVT) injection of aflibercept, an approved therapy, in patients suffering from wet age-related macular degeneration (wet AMD) or diabetic macular edema (DME). 

“We are excited to initiate the first stage of our Phase 2 study evaluating our subcutaneous anti-VEGF wet AMD and DME candidate, D-4517.2. We believe in its potential to not only treat neovascular retinal diseases but also reduce the burden of treatment often associated with invasive IVT injections into the eye. A subcutaneously administered treatment offers an at-home option that patients can administer themselves,” said Jeffrey Cleland, Ph.D., Chairman, CEO and President of Ashvattha Therapeutics. “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.”

Jeffrey Heier, MD, Director of Retina Research at Ophthalmic Consultants of Boston, added, “The potential of HDT treatment for wet AMD and DME is in the systemic administration combined with the high degree of selectivity for inflammatory cells in the back of the eye, targeting diseased cells, potentially reducing the VEGF levels to normal while minimizing or eliminating entirely off-target effects. We look forward to further exploring D-4517.2’s potential to improve the current treatment paradigm for patients.”

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