Enrollment completion of sozinibercept Phase 3 program for wet AMD expected in calendar year (CY) Q2 2024 with top-line data mid-CY 2025
Expanded U.S. leadership team with the appointments of Dr. Frederic Guerard as CEO, Peter Lang as CFO, and Dr. Arshad M. Khanani as Chief Medical Advisor
Cash and cash equivalents of $157.1 million as of December 31, 2023
MELBOURNE, Australia and PRINCETON, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) — Opthea Limited ((ASX:OPT, NASDAQ:OPT, “Opthea”)), a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, today announced financial results for the six months ended December 31, 2023 and highlighted recent corporate and clinical updates.
“It is a transformative time for Opthea. We substantially advanced the development of sozinibercept, our lead product candidate for the treatment of wet age-related macular degeneration (wet AMD), expanded our U.S. leadership team, strengthened our clinical and regulatory organization, and received US$143 million in funding. We recently announced the completion of enrollment in our first pivotal Phase 3 trial (COAST), in combination with EYLEA® (aflibercept),” said Frederic Guerard, PharmD, Chief Executive Officer of Opthea.
“We believe that sozinibercept has the potential to deliver superior vision gains for millions of people with wet AMD based on our Phase 2b trial results which demonstrated superior and statistically significant improvements in visual acuity for patients treated with sozinibercept in combination with LUCENTIS®(ranibizumab). Sozinibercept therefore has the potential to be the first product in more than 15 years to improve the standard of care in wet AMD and make a tangible difference in the lives of patients,” continued Dr. Guerard.
Peter Lang, Chief Financial Officer of Opthea, added, “We are excited about Opthea’s progress. Looking ahead, we expect to complete enrollment in our second Phase 3 trial (ShORe), in combination with the standard of care ranibizumab, in the second quarter of CY 2024. In addition, we intend to report the top-line data on the COAST and ShORe trials in mid-CY 2025. We are encouraged by the positive momentum in the sozinibercept program.”
Anticipated Milestones
Enrollment completion in the second Phase 3 pivotal ShORe trial, evaluating sozinibercept in combination with ranibizumab, expected in Q2 CY 2024.
Top-line Phase 3 results from the COAST and ShORe trials expected by mid-CY 2025.
Corporate Highlights
In February 2024, completed enrollment in the COAST Phase 3 pivotal trial evaluating sozinibercept in combination with aflibercept.
In February 2024, Dr. Arshad M. Khanani, FASRS, a global retina expert joined as Chief Medical Advisor to support sozinibercept development and launch preparation.
In February 2024, strengthened the organization with key clinical and regulatory hires including Dr. Julie Clark as SVP, Clinical Development, and Dr. Fang Li as SVP, Regulatory Affairs.
In December 2023, Opthea received US$85 million in non-equity funding consisting of the remaining US$35 million from the previously announced Development Funding Agreement (DFA) with Carlyle and its life science franchise, Abingworth, and an additional US$50 million under an amended DFA with a new co-investor.
In October 2023, appointed U.S.-based leadership team with Dr. Frederic Guerard as Chief Executive Officer and Peter Lang, MBA, as Chief Financial Officer, and the transition of …