Ashvattha Therapeutics Presents Positive Interim Phase 2 Results for Subcutaneous Migaldendranib Treatment for DME and Wet AMD

Ashvattha Therapeutics announced interim results from its ongoing phase 2 study of subcutaneous (subQ) migaldendranib (MGB) for the treatment of diabetic macular edema (DME) and wet age-related macular degeneration (AMD). The data were presented at the MaculArt Meeting, June 29–July 1, 2025 in Paris.

MGB represents a potential alternative to current standard of care, which requires patients to receive intravitreal injections every 4 to 12 weeks in a clinical setting. According to Ashvattha, MGB is a first-in-class subcutaneously administered candidate being developed for convenient, at-home monthly treatment of DME and wet AMD, aiming to reduce treatment burden while avoiding systemic side effects.

Unlike current anti-VEGF therapies that require repeated intravitreal injections directly into the eye, subcutaneously (subQ) administered MGB provides a unique mechanism of action of normalizing vascular endothelial growth factor (VEGF) expression in activated macrophages, microglia and retinal pigment epithelial cells in the retina. By reducing VEGF expression, MGB reduces the need for anti-VEGF intravitreal injections improving patient adherence.

Data presented in the presentation titled " Subcutaneous Migaldendranib (MGB) for the Treatment of Neovascular Age-Related Macular Degenerations and Diabetic Macular Edema: Interim Results of Chronic Dosing Phase 2 Study" showed that subQ MGB demonstrated promising safety and tolerability in both DME and wet AMD patients in the first 24 weeks of treatment. According to Ashvattha, the study used more conservative supplement criteria compared to other recent clinical studies, with rescue anti-VEGF injections given when central subfield thickness increased above baseline, rather than the >75 μm increase from lowest value used in other studies. The interim analysis included 19 subjects who completed 24 weeks (11 wet AMD, 8 DME).

Results:

• DME patients exhibited an increased best corrected visual acuity (BCVA) of +4.5 letters and a decreased central subfield thickness (CST) of -69.1 µm, with an observed reduction in treatment burden by 80%
• Wet AMD patients maintained stable mean BCVA and CST for 24 weeks with +3 letters, -45.5µm CST and a comparable 79.9% reduction in treatment burden
• Notably, fellow eye results also showed substantial treatment burden reduction of approximately 75% compared to pre-treatment, demonstrating the potential bilateral benefits of subcutaneous administration
• Safety findings included injection site reactions in 8.6% of injections administered, which were localized, transient and mostly mild

End of study results will be presented at an upcoming conference.

“These results demonstrate a potential paradigm shift in the treatment of DME and wet-AMD patients,” Jeff Cleland, PhD, CEO of Ashvattha Therapeutics, said in a company news release. “The interim phase 2 data support the potential of subcutaneous MGB to offer patients a convenient, once-monthly alternative to frequent eye injections. By targeting inflammation and fluid accumulation in both eyes with a single systemic dose, we may be able to significantly reduce treatment burden and improve quality of life. We look forward to advancing this novel treatment for DME and wet-AMD and to bringing a new treatment forward for patients who need it most.”

These data were also presented at the Clinical Trials at the Summit, June 21, 2025, in Las Vegas.