Ashvattha reports positive phase 2 data for migaldendranib in retinal diseases

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Ashvattha Therapeutics recently announced positive interim phase 2 results for migaldendranib (MGB).¹ MGB is described as a novel subcutaneously administered nanomedicine for the treatment of retinal vascular diseases.

The safety and efficacy of subcutaneous (subQ) MGB was evaluated in a phase 2 chronic dosing, open-label study in 27 subjects. The 27 subjects – 16 of which had wet age-related macular degeneration (AMD) and 11 of which had diabetic macular edema (DME) – had all previously been 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, the company said in a press release. “SubQ-administered MGB selectively targets activated cells in the retina, reducing VEGF expression and fluid production in both eyes simultaneously,” the company’s release said.

Subjects received a single anti-VEGF IVT and subQ MGB at baseline, followed by subQ MGB every 2 or 4 weeks for 40 weeks. An interim analysis focused on 24-week data from 8 wet AMD and 6 DME subjects.

Ashvattha shared the company’s new data from the subjects who completed 24 weeks of treatment in a poster presented at the 2025 Association for Research in Vision and Ophthalmology (ARVO) annual meeting held May 4-8 in Salt Lake City.

This data presented includes¹

A 79.9% reduction in wet AMD subjects and an 80% reduction in DME subjects compared to the 24 weeks prior to day 1. These results represent a 5.0-fold decrease in anti-VEGF treatment burden for both indications.
A bilateral treatment effect with 66.7% reduction in fellow eye IVT injections for wet AMD subjects and 85.5% reduction for DME subjects.
From baseline to week 24, the mean best corrected visual acuity improved by 3 letters in study eye of wet AMD subjects and improved by 4.5 letters in DME subjects.
A mean central subfield thickness improvement of 45.5 microns in subjects with wet AMD and an improvement of 69.1 microns in subjects with DME.
No serious adverse events or ocular adverse events related to MGB were reported. Injection site reactions were reported in 5 subjects (3 with wet AMD and 2 with DME), with only 26 total reactions across the 302 total subcutaneous injections.

Reference

Ashvattha Therapeutics. Ashvattha Therapeutics to Present Positive Phase 2 Results for Subcutaneous Migaldendranib in Retinal Vascular Disease at ARVO. GlobeNewswire News Room. Published May 7, 2025. Accessed May 15, 2025. https://www.globenewswire.com/news-release/2025/05/07/3076720/0/en/Ashvattha-Therapeutics-to-Present-Positive-Phase-2-Results-for-Subcutaneous-Migaldendranib-in-Retinal-Vascular-Disease-at-ARVO.html