Opthea Completes Enrollment in First Pivotal Trial of Sozinibercept for Wet AMD
Opthea announced it has completed enrollment of all patients in the COAST phase 3 pivotal clinical trial investigating sozinibercept (OPT-302, a vascular endothelial growth factor (VEGF)-C/D inhibitor) in combination with aflibercept, an anti-VEGF-A therapy, for the treatment of wet age-related macular degeneration (AMD). The sozinibercept clinical program includes two phase 3 pivotal trials, COAST and ShORe. Enrollment in ShORe is expected to be completed in calendar Q2 2024. Opthea intends to report topline results from these two trials by mid-2025.
“Completion of patient enrollment in our first pivotal trial marks an important milestone in the development of sozinibercept for the treatment of wet AMD. We believe sozinibercept has the potential to provide superior clinical results, based on the strength of our phase 2b trial, which demonstrated a statistically significant improvement in visual acuity for patients treated with sozinibercept combined with Lucentis (ranibizumab) compared to ranibizumab alone,” Frederic Guerard, PharmD, Chief Executive Officer of Opthea, said in a company news release. “We look forward to maintaining this positive momentum and completing enrollment in the ShORe pivotal trial in calendar Q2 2024, with a goal of communicating topline results for both trials by mid-2025.”
Sozinibercept (OPT-302) is a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3) expressed as an immunoglobulin G1 (IgG1) Fc-fusion protein. It binds and neutralizes the activity of VEGF-C and VEGF-D on their endogenous receptors, VEGFR-2 and VEGFR-3. Research indicates that targeted inhibition of VEGF-C and VEGF-D can prevent blood vessel growth and vascular leakage which contribute to the pathophysiology of retinal diseases including wet AMD. Sozinibercept has received Fast Track Designation from the FDA for the treatment of wet AMD.
About COAST and ShORe Phase 3 Clinical Trials
Opthea is conducting two concurrent global pivotal phase 3 clinical trials for the treatment of wet AMD aiming at demonstrating superiority of its combination therapy versus standard of care: COAST (Combination OPT-302 with Aflibercept Study) and ShORe (Study of OPT-302 in combination with ranibizumab). If successful, the investigation of sozinibercept in combination with each of these two approved standard of care VEGF-A inhibitors could enable sozinibercept to be administered with either agent, Eylea (aflibercept) or Lucentis (ranibizumab).
The two pivotal phase 3 multicenter, double-masked, sham-controlled trials are designed to assess the efficacy and safety of intravitreal 2.0 mg sozinibercept in combination with anti-VEGF-A treatments. In the COAST trial, sozinibercept is being evaluated in combination with 2.0 mg of Eylea (aflibercept). In the ShORe trial, sozinibercept is being evaluating in combination with 0.5 mg of Lucentis (ranibizumab). The primary endpoint for both trials is the mean change in best corrected visual acuity (BCVA) from baseline to week 52 for sozinibercept combination therapy compared to anti-VEGF-A monotherapy.
In addition, each trial will evaluate the use of sozinibercept treatment dosed every 4 weeks and every 8 weeks after the first three loading doses.
Beyond week 52, patients will continue to be treated for an additional year to evaluate extended safety and tolerability up to a 2-year period.