Opthea Achieves Major Milestone in Manufacturing Process for Sozinibercept
OPT (OPT) Share Update September 2024 Wednesday 18th
Opthea Completes Key Manufacturing Milestone for Sozinibercept
Opthea Limited (ASX/NASDAQ: OPT), a clinical-stage biopharmaceutical company, has announced the successful completion of its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept, marking a significant step towards a potential biologics license application (BLA) filing for the treatment of wet age-related macular degeneration (wet AMD).
Instant Summary:
- Completion of three consecutive commercial-scale batches of sozinibercept.
- Major milestone towards potential BLA filing for wet AMD treatment.
- Progress update on drug product PPQ campaign expected in early 2025.
Key Milestone Achieved
Opthea Limited has successfully completed its drug substance Process Performance Qualification (PPQ) campaign for sozinibercept. This campaign involved producing three consecutive commercial-scale batches of the drug substance, a crucial step in validating the company's manufacturing process.
The successful completion of these batches is a significant milestone towards de-risking the program and potentially filing a biologics license application (BLA) for sozinibercept in the treatment of wet age-related macular degeneration (wet AMD). This achievement demonstrates Opthea's ability to consistently manufacture quality drug substance at a commercial scale, which is essential for the BLA Chemistry, Manufacturing, and Controls (CMC) module.
CEO's Comments
Fred Guerard, PharmD, Chief Executive Officer of Opthea, expressed his satisfaction with the milestone, stating, 'The successful completion of the drug substance PPQ campaign is an important step towards de-risking the program and a potential BLA filing of sozinibercept in wet AMD.' He emphasized the company's ongoing efforts to advance its two fully enrolled, pivotal Phase 3 trials of sozinibercept in wet AMD.
Future Plans
Mark O'Neill, Vice President of Technical Operations at Opthea, highlighted the company's readiness to supply both the planned drug product PPQ campaign and initial launch materials. He added that a progress update on the drug product PPQ campaign is expected in early 2025.
Opthea's lead product candidate, sozinibercept, is currently being evaluated in two pivotal Phase 3 clinical trials for use in combination with standard-of-care anti-VEGF-A monotherapies. These trials aim to improve overall efficacy and deliver superior vision gains compared to standard-of-care anti-VEGF-A agents.
The successful completion of the drug substance PPQ campaign is a positive development for Opthea, potentially accelerating the timeline for a BLA filing for sozinibercept. This milestone reduces the risk associated with the manufacturing process and could boost investor confidence in the company's ability to bring sozinibercept to market. The announcement is likely to have a favorable impact on Opthea's stock price, as it demonstrates significant progress in the company's clinical and manufacturing efforts.
Investor Reaction:
Analysts are expected to react positively to the news, given the importance of the PPQ campaign in the regulatory approval process. The successful completion of this milestone reduces the risk associated with the manufacturing of sozinibercept and increases the likelihood of a timely BLA filing. Investors may view this as a strong indicator of Opthea's potential for future growth and market success.
Conclusion:
Investors should keep an eye on Opthea's progress as the company moves closer to filing a BLA for sozinibercept. The successful completion of the drug substance PPQ campaign is a significant achievement that positions Opthea well for future developments. Stay tuned for further updates on the drug product PPQ campaign expected in early 2025.