End of the road for Oxurion as third DME candidate flunks

20 Nov 2023
firstwordpharma.com
Phase 2Clinical ResultClinical Trial Failure
Oxurion said Monday that it will file for bankruptcy after its only ongoing clinical study failed to meet its primary endpoint. The Phase II KALAHARI trial was investigating the experimental plasma kallikrein (PKal) inhibitor THR-149 in patients with diabetic macular oedema (DME) who have previously shown a suboptimal response to anti-VEGF therapy.
However, top-line results showed that in Part B of the study – which included 112 patients - THR-149 did not improve vision as much as Sanofi and Regeneron Pharmaceuticals’ anti-VEGF therapy Eylea (aflibercept) at month three. Specifically, the mean change in best corrected visual acuity (BCVA) from baseline at was -0.2 letters forTHR-149 and +3.5 letters for Eylea.
CEO Tom Graney said he is “deeply disappointed” in the results, adding that combined with Oxurion’s low cash position, the board “has made the difficult decision to take the necessary steps to file for bankruptcy.”
Last year, the company stopped development of the integrin antagonist THR-687 in DME after the first portion of a Phase II study failed to meet its efficacy endpoints. Prior to this, Oxurion’s PIGF inhibitor THR-317 did not show an increase in BCVA in the same indication.
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