Clinical stage biopharmaceutical company Opthea, based in Melbourne, has adopted the non-proprietary drug name “sozinibercept” for its lead drug candidate, OPT-302.
The company – producing therapies for progressive retinal diseases – announced 26 July the American Medical Association’s United States Adopted Names (USAN) Council, in consultation with the World Health Organization (WHO)’s International Non-proprietary Names (INN) Expert Committee, has approved the drug name.
Sozinibercept (OPT-302) is the company’s novel recombinant “trap” fusion protein targeting inhibition of VEGF-C and VEGF-C in retinal vascular diseases.
The investigational therapy is administered by intravitreal injection in combination with standard of care anti-VEGF-A therapy and is currently being evaluated in two Phase 3 clinical trials for the treatment of neovascular age-related macular degeneration (nAMD), for which it holds fast track designation from the US Food and Drug Administration (FDA).
Sozinibercept is proprietary to Opthea with issued patents running to at least 2034 and currently pending patents that are expected to extend coverage.
The USAN Council, with the INN Program of the WHO and in consultation with various national nomenclature groups, aims for global standardisation of drug nomenclature classifications based on pharmacological and/or chemical relationships, to ensure clear and accurate communication of drug information.
Opthea will now use the name sozinibercept in upcoming publications and public statements, at conferences and other forums, and in corporate-related materials as the company continues to advance the clinical development toward commercialisation of the product in nAMD and other indications. The company is also pursuing a formal global proprietary brand name for sozinibercept.
The company said obtaining regulatory approval of these adopted drug names is a necessary step for marketing authorisation.
Opthea is currently conducting two global pivotal registrational Phase 3 studies, the ShORe trial of 2 mg sozinibercept + 0.5 mg ranibizumab, and the COAST trial of 2 mg sozinibercept + 2 mg aflibercept. The primary endpoint for both studies is superiority in visual acuity gains at 12 months for the combination therapy compared with standard-of-care monotherapy.
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