- Subcutaneous administration generally safe and well-tolerated across multiple doses
- >80% reduction in anti-VEGF intravitreal injection burden in wet AMD and DME study eyes and >75% total reduction in fellow eyes
- Maintenance of vision and anatomical improvements in study eye and fellow eye of patients previously treated with intravitreal anti-VEGF
- First-in-class dendrimer nanomedicine that treats both eyes simultaneously with monthly at-home subcutaneous dosing
REDWOOD CITY, Calif., May 07, 2025 (GLOBE NEWSWIRE) -- Ashvattha Therapeutics ("Ashvattha"), a clinical-stage company advancing a new class of nanomedicine therapeutics that traverse tissue barriers to selectively target and reprogram activated cells in regions of inflammation, today announced positive interim Phase 2 results for migaldendranib (MGB), a novel subcutaneously administered nanomedicine treatment for retinal vascular diseases. Updated results were presented in a poster session at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting taking place May 4 – May 8, 2025, in Salt Lake City, UT.
The Phase 2 chronic dosing, open-label study evaluated the safety and efficacy of subcutaneous (subQ) MGB in 27 subjects (16 with wet AMD and 11 with DME) who were previously treated with anti-VEGF intravitreal injections (IVT) and met responder criteria. MGB is a VEGF receptor tyrosine kinase inhibitor delivered via a hydroxyl dendrimer platform. SubQ-administered MGB selectively targets activated cells in the retina, reducing VEGF expression and fluid production in both eyes simultaneously. This approach targets the source of fluid leakage rather than the need for therapies that remove the fluid after an anti-VEGF injection in the eye. Subjects received a single anti-VEGF IVT and subQ MGB at baseline, followed by subQ MGB every 2 or 4 weeks for 40 weeks. The interim analysis focuses on 24-week data from 8 wet AMD and 6 DME subjects. The last patient completed the 40-week study in early May.
In subjects completing 24 weeks of treatment, updated results presented at ARVO show:
- 79.9% reduction in wet AMD subjects and 80.0% reduction in DME subjects compared to the 24 weeks prior to Day 1, representing a 5.0-fold decrease in anti-VEGF treatment burden for both indications
- Bilateral treatment effect with 66.7% reduction in fellow eye IVT injections for wet AMD subjects and 85.8% reduction for DME subjects
- Mean best corrected visual acuity improved by 3 letters in study eye of wet AMD subjects (from baseline to week 24) and improved by 4.5 letters in study eye of DME subjects (from baseline to week 24)
- Mean central subfield thickness improved by 45.5 microns in wet AMD subjects and by 69.1 microns in DME subjects
- No serious adverse events or ocular adverse events related to MGB were reported. Injection site reactions were reported in 5 subjects (3 wet AMD, 2 DME), with only 26 reactions across 302 total subcutaneous injections (8.6%), mostly Grade 1 (mild)
"These updated Phase 2 results demonstrate MGB’s potential to address a significant unmet need in retinal vascular diseases," said Jeff Cleland, Ph.D., CEO of Ashvattha Therapeutics. "A monthly subcutaneous injection that effectively treats both eyes simultaneously while improving vision and reducing retinal fluid addresses a significant unmet need. We look forward to advancing this promising therapy into late-stage clinical development.”
About Ashvattha Therapeutics
Ashvattha Therapeutics is advancing a new class of clinical-stage nanomedicine therapeutics that traverse tissue barriers to selectively target and reprogram 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. Ashvattha Therapeutics was founded by Kannan Rangaramanujam, Sujatha Kannan, and Jeff Cleland and incubated by Natural Capital. For more information, visit: www.avttx.com
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