Opthea’s eye disease drug has failed its second phase 3 trial in a week, leaving the Australian biotech to discard the entire wet age-related macular degeneration (AMD) program.
Sozinibercept, an inhibitor of vascular endothelial growth factors (VEGFs) C and D, already came up short against Regeneron’s blockbuster VEGF inhibitor Eylea in the phase 3 Coast study of patients with wet AMD last week. At the time, Opthea said it would consider the impact on the phase 3 Shore trial—which has been assessing sozinibercept in combination with Novartis’ Lucentis and was due to read out this year.
This morning, Opthea said it had sped up a readout for the Shore trial—and it’s been another fail.
Specifically, 2 mg sozinibercept every four or eight weeks in combination with 0.5 mg Lucentis every four weeks was unable to beat Lucentis alone when it came to improving eyesight as measured by best corrected visual acuity (BCVA) from baseline at Week 52.
The 654 patients who received either the four- or eight-week sozinibercept regimen saw a mean BCVA change of 13.3 or 12.6 letters, respectively, compared to 14.3 letters for the 331 individuals who received Lucentis monotherapy.
When it announced the failure of the Coast study last week, Opthea warned that it needed to reach out to investors to try to avoid its debts and additional charges being called in. The company said this morning that it is still having “active discussions” to try to avoid this outcome.
The company currently has around $100 million to hand in cash and equivalents.
“In light of these matters, there remains material uncertainty as to Opthea's ability to continue as a going concern,” the biotech said.
The company doesn’t have any other trials ongoing, although the biotech’s pipeline on its website describes sozinibercept as being “phase 3 ready” in another eye disease called diabetic macular edema.