- Open-label study will evaluate the safety and efficacy of chronic D-4517.2 dosing in patients with wet age-related macular degeneration (wet AMD) or diabetic macular edema (DME)
- Favorable safety and tolerability results from Phase 1 and Phase 2 single dose studies of D-4517.2 support initiation of chronic dosing study
- Preliminary data expected in 1H 2024
REDWOOD CITY, Calif., November 1, 2023 – Ashvattha Therapeutics (“Ashvattha”), a clinical-stage company advancing a new class of nanomedicine therapeutics that traverse tissue barriers to selectively target activated cells in regions of inflammation, today announced that the first patient has been dosed with D-4517.2, a subcutaneously administered anti-angiogenic therapeutic, in a Phase 2 chronic dosing study. The open-label study will evaluate the safety and efficacy of chronic D-4517.2 dosing in patients with wet AMD and DME.
“This study marks a significant step forward in advancing D-4517.2 as an at-home, maintenance treatment option for patients with wet AMD and DME. We believe that D-4517.2 will extend the time between anti-VEGF treatments, thereby reducing the anxiety patients typically experience with intravitreal injections and also lessening the burden of frequent office visits. Furthermore, subcutaneous administration of D-4517.2 doses both eyes at the same time, increasing the potential benefit for the 40-50% of patients with bilateral disease,” said Jeff Cleland, Ph.D., CEO, and chairman of Ashvattha Therapeutics. “We look forward to sharing preliminary results from this study in the first half of 2024.”
The Phase 2 open-label chronic dosing study will enroll at least 20 subjects with wet AMD or DME, with each acting as their own control. Participants will first be dosed with only aflibercept, an anti-VEGF agent administered via intravitreal injection (injected directly into the eye), to determine the time to return of fluid in each subject in a controlled setting. Following the return of fluid to baseline levels, subjects will be concurrently dosed with both aflibercept and D-4517.2. Subsequently, subjects will receive D-4517.2 by subcutaneous injection every two or four weeks for up to 40 weeks.
The primary objectives of the study are to evaluate the safety and tolerability of multiple D-4517.2 subcutaneous doses and the ability of different D-4517.2 dose regimens to maintain best corrected visual acuity (BCVA) and central subfield thickness (CST) following a single intravitreal aflibercept dose. An important metric for assessing the clinical benefit of D-4517.2 in this “treat-to-maintain” paradigm is the time to aflibercept rescue following the initial aflibercept dose.
To date, D-4517.2 has been well-tolerated in human and animal studies without observed off-target effects. The initiation of the Phase 2 chronic dosing study is supported by results from Phase 1 and Phase 2 single dose studies that demonstrated good safety and tolerability of D-4517.2. There were no concerning changes in laboratory measurements including liver enzymes that are known to be affected by systemic administration of tyrosine kinase inhibitors. This favorable human safety profile is consistent with chronic nonclinical toxicology studies for D-4517.2 and clinical studies with other product candidates utilizing Ashvattha’s hydroxyl dendrimer technology.
About Wet AMD and DME
Wet age-related macular degeneration (wet AMD) is a retinal disease that develops when abnormal blood vessels grow into the macula – a part of the retina at the back of the eye responsible for sharp central vision. These vessels leak blood or fluid leading to rapid loss of central vision. Diabetic macular edema (DME) is a retinal disease that develops when fluid accumulates in the macula due to leaking blood vessels. DME is a result of diabetic retinopathy, a disease that damages the blood vessels in the retina which if left untreated results in vision loss. Industry sources1 estimate that in the United States, there are nearly 2 million people who have been diagnosed with wet AMD and over 3 million diagnosed with DME. The current standard of care treatment for both conditions involves repeated intravitreal injections of anti-VEGF agents.
About D-4517.2
D-4517.2 (hydroxyl dendrimer VEGFR tyrosine kinase inhibitor) is a potent, subcutaneously administered anti-angiogenic nanomedicine that crosses the blood-retinal barrier and selectively targets activated microglia, macrophages, and hypertrophic retinal pigment epithelial cells in the eye. D-4517.2 has the potential to change the current treatment paradigm for neovascular age-related macular degeneration (wet AMD) and diabetic macular edema (DME) by extending the time between intravitreal anti-VEGF injections via a subcutaneous injection self-administered by the patient. Furthermore, subcutaneous administration of D-4517.2 has the potential to treat both eyes at the same time, a significant benefit for 40-50% of patients with bilateral disease. D-4517.2 is in a Phase 2 chronic dosing clinical trial in subjects with wet AMD or DME.
About Ashvattha Therapeutics
Ashvattha Therapeutics is advancing a new class of clinical-stage nanomedicine therapeutics that transverse tissue barriers to selectively target activated cells only in regions of inflammation. Our targeted nanomedicine approach seeks to redefine precision medicine, empowering a new standard of care across ophthalmology, neurology, and inflammation. For more information, visit: www.avttx.com
- Roche/Genentech in Pharma Day 2021 presentation
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