Ashvattha Therapeutics announced positive Phase 2 trial data for its subcutaneously administered nanomedicine, Migaldendranib (MGB), designed to treat retinal diseases like wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). The therapy aims to reduce the need for frequent intravitreal (IVT) injections by targeting and reducing fluid production in the retina of both eyes. Interim results from the trial involving 25 pre-treated patients demonstrated a significant reduction in the need for anti-VEGF IVT injections while maintaining or improving visual acuity.
This development is potentially transformative for patients with chronic retinal diseases. Current treatment relies on regular IVT injections, which are invasive, inconvenient, and can cause anxiety. A successful subcutaneous therapy could shift the treatment paradigm, offering patients a more comfortable, self-administered alternative, leading to improved compliance and potentially better outcomes. Decreased reliance on clinic visits also frees up valuable resources for healthcare systems.
The Phase 2 trial data shows MGB reduced the need for anti-VEGF injections by 69.2% in wet AMD patients and 76.5% in DME patients over 24 weeks. Importantly, the therapy demonstrated efficacy in both eyes, even though only one eye received an initial IVT injection of aflibercept. The treatment was generally well-tolerated, with no reported drug-related ocular adverse events.
MGB’s positive Phase 2 results represent a significant step towards a less invasive and more patient-friendly treatment for retinal diseases. If further trials confirm these findings, MGB could revolutionize the management of these conditions, improving patients’ quality of life while potentially reducing the overall healthcare burden. Further research will focus on longer-term efficacy and safety, as well as exploring potential applications for other retinal diseases.
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.
