Ashvattha Therapeutics announced positive interim Phase 2 results for its subcutaneously administered nanomedicine, migaldendranib (MGB), designed to treat retinal vascular diseases like wet age-related macular degeneration (AMD) and diabetic macular edema (DME). The study showed MGB significantly reduced the need for intravitreal anti-VEGF injections, improved vision, and decreased retinal fluid in patients previously treated with these injections. This approach is notable as it targets the source of fluid leakage in both eyes simultaneously through a monthly subcutaneous injection, a departure from current treatments requiring injections directly into the eye.
This development is potentially transformative for patients with retinal vascular diseases. Current treatment regimens involving frequent intravitreal injections are burdensome and can negatively impact patient quality of life. MGB offers the possibility of less frequent, less invasive treatment while maintaining or even improving visual outcomes. This could lead to improved patient compliance and ultimately better long-term vision preservation.
The 24-week interim analysis of the Phase 2 study revealed an approximately 80% reduction in the need for anti-VEGF injections in both wet AMD and DME patients. Fellow eyes also saw a significant reduction in needed injections, highlighting the drug’s bilateral effects. Furthermore, patients experienced an improvement in visual acuity and a reduction in retinal fluid thickness. Importantly, MGB appears to be well-tolerated, with only mild injection site reactions reported.
These positive interim results suggest MGB could become a valuable new treatment option for retinal vascular diseases. Pending further clinical development and regulatory approval, this nanomedicine holds the promise of a paradigm shift in how these conditions are managed, offering patients a more convenient and potentially more effective therapy. The completion of the full 40-week study will provide further insights into the long-term efficacy and safety profile of MGB, paving the way for potential late-stage clinical trials.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
