Exonate has announced plans to initiate a phase 2b clinical trial of its lead candidate EXN407, a topical SRPK1 inhibitor, for non-proliferative diabetic retinopathy (NPDR). The CLEAR-DE trial is scheduled to begin in early 2026.
The study will evaluate efficacy, dosing and safety in 140 NPDR patients across sites in Australia, the Middle East and China.
The decision follows positive results from Exonate’s phase 1b/2a trial in March 2024. EXN407 met its safety and tolerability endpoints, with no drug-related serious adverse events and high patient compliance.
Exploratory efficacy signals showed reduced vascular leakage, a key driver of diabetic retinopathy progression.
Diabetic retinopathy affects around one-third of the global diabetic population. NPDR, its early stage, can lead to vision-threatening complications if untreated.
Current treatments rely on monthly intraocular injections, typically delayed until symptoms worsen. This limits early intervention and can result in irreversible damage.
EXN407 is a first-in-class, twice-daily eye drop formulation designed to inhibit SRPK1. It modulates VEGF expression via alternative mRNA splicing, targeting pro-angiogenic isoforms responsible for abnormal retinal blood vessel growth.
Dr Catherine Beech, Chief Executive Officer of Exonate, said: “The phase Ib/IIa data demonstrated the clear potential of EXN407 as a non-invasive treatment for diabetic eye disease.”
She added: “This therapy could transform the treatment landscape for early-stage disease by providing clinical benefit while avoiding the burden of injections, representing a significant advancement for patients and physicians alike. We’re excited to progress to the CLEAR-DE phase IIb trial and are actively seeking strategic partners to support its execution.”
