UK biotechnology company, Exonate Ltd, is initiating a Phase IIb clinical trial for its lead candidate EXN407. The CLEAR-DE (Clinical Evaluation of a New Eye Drop for Alleviating Retinopathy in Diabetic Eye Disease) trial "will further evaluate the clinical efficacy, optimal dosing and safety profile of EXN407 in patients with non-proliferative diabetic retinopathy (NPDR)."
The progression to a phase IIb clinical study follows encouraging results from Exonate’s phase Ib/IIa study in March 2024, in which lead candidate EXN407 met its primary safety and tolerability endpoints, with no drug-related serious adverse events, and high patient compliance. EXN407 is a first-in-class, twice-daily topical formulation of a selective SRPK1 inhibitor – a minimally-invasive approach with potential to become the first effective eye-drop therapy for NPDR and diabetic macular oedema (DME). Designed to modulate expression of vascular endothelial growth factor (VEGF) via alternative mRNA splicing, EXN407 selectively inhibits the pro-angiogenic isoforms that drive disease progression, causing abnormal and leaky blood vessel formation in the retina.
“The phase Ib/IIa data demonstrated the clear potential of EXN407 as a non-invasive treatment for diabetic eye disease,” said Dr. Catherine Beech, Chief Executive Officer of Exonate.
