• Multiple subcutaneous doses safe and well-tolerated
  • >69% reduction in anti-VEGF intravitreal (IVT) treatment burden in study eyes
  • >67% reduction in anti-VEGF IVT treatment in fellow eyes of bilateral disease patients
  • Maintenance of BCVA and reduction of CST in these previously treated patients
  • Migaldendranib therapy obviates or reduces the need for more invasive in-the-eye injections

REDWOOD CITY, Calif., Feb. 10, 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 Phase 2 data for Migaldendranib (MGB; D-4517.2), a novel subcutaneously (subQ) administered nanomedicine treatment for retinal diseases. SubQ administered MGB selectively targets and reduces fluid production in the retina of both eyes to reduce the need for therapies that remove the fluid after an injection in the eye.  Over 50 subjects have been treated to date across three clinical trials. The interim results of the chronic subQ MGB dosing Phase 2 study for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) were presented at the Angiogenesis, Exudation, and Degeneration 2025 virtual meeting on February 8, 2025.

The data were presented by Michael Singer, M.D., Clinical Professor of Ophthalmology at the University of Texas Health Science Center San Antonio and Director of Clinical Research at Medical Center Ophthalmology San Antonio.

The ongoing Phase 2 study includes 25 patients (16 wet AMD and 9 DME), previously treated with anti-VEGF IVT injections, and is evaluating the novel, proprietary nanomedicine, MGB, which is subcutaneously administered every 2 or 4 weeks for up to 40 weeks after a single intravitreal injection of aflibercept (2 mg) at Day 1 (Baseline).

"These results suggest that subcutaneous MGB could potentially offer patients a more convenient at-home treatment option while maintaining disease control and significantly reducing IVT injection burden," said Dr. Singer. "The bilateral treatment effect is particularly encouraging for patients with disease in both eyes."

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In subjects completing 24 weeks of treatment at this interim analysis, key findings included:

  • 69.2% and 76.5% reduction in anti-VEGF treatment burden for wet AMD and DME study eyes, respectively, versus 24 weeks prior to screening
  • Maintenance of mean central subfield thickness (CST) and best corrected visual acuity (BCVA) in wet AMD study eyes
  • Modest decreases in CST (-69.1 microns) with modest increases in BCVA (+4.5 ETDRS letters) in DME study eyes
  • Similar effects observed in fellow eyes, which did not receive an anti-VEGF IVT at Day 1 (Baseline), with 66.7% and 94.7% reduction in treatment burden for wet AMD and DME subjects, respectively, with bilateral disease versus 24 weeks prior to screening
  • Generally safe and well-tolerated with no treatment-related ocular adverse events reported

"These promising results highlight our dedication to developing innovative therapies for wet AMD and DME,” said Jeff Cleland, Ph.D., CEO of Ashvattha Therapeutics. "For subjects who have completed 24 weeks of treatment, there has been a significant reduction in the need for supplemental intravitreal aflibercept. Migaldendranib has the potential to be administered at home subcutaneously once per month to reduce the production of fluid in the retina, reducing the need for injections of anti-VEGF in the eye. These results substantially reduce treatment burden for patients, especially those with bilateral disease, leading to less office visits. We are encouraged by these findings and look forward to continuing our development efforts to bring this promising therapy to market."

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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