Ashvattha Therapeutics has announced promising interim Phase 2 results for its investigational drug, migaldendranib (MGB), in patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). The data, presented at the Angiogenesis, Exudation, and Degeneration 2025 virtual meeting, indicate that subcutaneous administration of MGB significantly reduces the need for frequent intravitreal injections, the current standard of care for these conditions.
The ongoing Phase 2 study is evaluating MGB, a novel, proprietary nanomedicine, administered subcutaneously every 2 or 4 weeks for up to 40 weeks following a single intravitreal injection of aflibercept (2 mg) at baseline. The trial includes 25 patients (16 with wet AMD and 9 with DME) who had been previously treated with anti-VEGF intravitreal injections.
Key Findings from the Interim Analysis
For subjects completing 24 weeks of treatment, the interim analysis revealed:
- A 69.2% reduction in anti-VEGF treatment burden for wet AMD study eyes compared to the 24 weeks prior to screening.
- A 76.5% reduction in anti-VEGF treatment burden for DME study eyes compared to the 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 with bilateral disease, which did not receive an anti-VEGF IVT at Day 1 (Baseline), with a 66.7% and 94.7% reduction in treatment burden for wet AMD and DME subjects, respectively, versus 24 weeks prior to screening
- The treatment was generally safe and well-tolerated, with no treatment-related ocular adverse events reported.
Potential Impact on Treatment Paradigm
"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. Michael Singer, 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 bilateral treatment effect is particularly encouraging for patients with disease in both eyes."
Jeff Cleland, Ph.D., CEO of Ashvattha Therapeutics, added, "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."
Ashvattha Secures Additional Funding
In addition to the positive clinical data, Ashvattha Therapeutics announced an extension of its Series B financing, securing up to $50 million led by Tribe Capital with existing investors led by Natural Capital. This funding will enable the company to complete the ongoing Phase 2 ophthalmology trial and a Phase 1/2 neuroinflammation trial.
Arjun Sethi, Chief Investment Officer of Tribe Capital, stated, "We believe Ashvattha is a broad platform for HDTs to target and reprogram activated innate immune cells in the human body. These cells are implicated in inflammation, cancer, heart disease, aging disorders, autoimmune and neurological diseases."
With the promising Phase 2 data and the additional funding, Ashvattha Therapeutics is poised to further advance the development of migaldendranib, potentially offering a less burdensome and more convenient treatment option for patients with wet AMD and DME.
