▎WuXiEdited by Kant Content Team

Exonate today announced positive results from the Phase 1b/2a clinical trial of its lead candidate drug EXN407. The data demonstrated the safety and tolerability of EXN407, as well as a clear signal of biological activity. The press release noted that these dataSupport the further development of EXN407 as the first topical treatment for retinal vascular diseases such as diabetic retinopathy and diabetic macular edema.Exonate plans to advance EXN407 into Phase 2b clinical trials.

This Phase 1b/2a clinical study evaluated the safety, tolerability, and biological activity signals of EXN407 as a monotherapy in treatment-naïve patients with mild/moderate non-proliferative diabetic retinopathy and mild diabetic macular edema. The independent dose-escalation committee determined that EXN407 was safe and well-tolerated, with 100% of patients completing the study without the need for anti-VEGF rescue therapy, and no significant or serious adverse events related to EXN407 were reported. Additionally, EXN407 was well-tolerated, with ocular comfort scores similar to those of placebo and artificial tears.

In addition to achieving the primary safety and tolerability endpoints, the study also observed promising signals of biological activity.Compared with the placebo group, the macular thickness in the EXN407 group continued to decrease, similar to the previously reported effects of anti-VEGF injections. The trial results further showed that 60% of patients in the EXN407 group had a significant reduction in vascular leakage, compared to 20% in the placebo group.

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