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of D-4517.2 for the Treatment of Wet AMD and DME","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase II"},{"orgOrder":0,"company":"Ashvattha Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ashvattha Therapeutics to Present Preclinical Data at the AACR and ARVO 2023 Annual Meetings","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Preclinical"},{"orgOrder":0,"company":"Ashvattha Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not 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Find Clinical Drug Pipeline Developments & Deals by Ashvattha Therapeutics
D-4517.2 (hydroxyl dendrimer VEGFR tyrosine kinase inhibitor) is a potent, subcutaneously administered anti-angiogenic nanomedicine. It is in phase 2 cliniclal studies for treatment of neovascular age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
Ashvattha will present preclinical data at ARVO on its oral formulation of D-4517.2, a potent anti-angiogenic nanomedicine, in a laser-induced choroidal neovascularization (CNV) mouse model, and compare its efficacy with intravitreal aflibercept.
First stage of study will evaluate safety and relative pharmacodynamic effect of different doses of subcutaneously administered D-4517.2 (hydroxyl dendrimer) compared to intravitreal (IVT) injection of aflibercept,in both wet AMD and DME patients up to 12 week.
Data showed OP-101 (N-acetyl Cysteine) delivered intravenously may have the potential to treat systemic inflammation and neuronal injury, reducing morbidity and mortality in hospitalized patients with severe COVID-19.
Preclinical data demonstrate its hydroxyl dendrimer-based therapeutics reduce toxicity in targeted delivery to plexiform neurofibroma, a slow growing tumor associated with neurofibromatosis type 1 (NF1).
Lead Product(s):
Hydroxyl Dendrimer Based Therapeutics
In animal toxicology studies, D-4517.2 demonstrated no evidence of genotoxicity and showed local reversible changes at the injection site when administered at dosages several times higher than the effective dose range determined for humans.
Proceeds will support Ashvattha’s pipeline of hydroxyl dendrimer therapeutics, including OP-101 and multiple clinical stage programs. Ashvattha launched a Phase 2 study in severe COVID-19 and in 2022 plans to launch a Phase 2 study in wet AMD/DME and Phase 1/2 study in ALS.
Under the terms of the exclusive licensing agreement, Huadong will advance research and development costs for Ashvattha’s hydroxyl dendrimer clinical candidates, OP-101, D-4517.2 and OP-801, and for additional preclinical candidates.
A single subcutaneous or oral dose of D-4517, a sunitinib analog, resulted in comparable or better inhibition of CNV to a single intravitreal (IVT) dose of aflibercept.
Ashvattha has developed a novel hepatocyte targeted hydroxyl dendrimer therapeutic which enables selective targeting of farnesoid X receptor agonists on hepatocytes through the asialoglycoprotein receptor mediated uptake after systemic administration.