Cambium Bio has secured FDA clearance to begin Phase 3 dosing of Elate Ocular, a promising treatment for moderate to severe dry eye disease, pending additional financing.
- FDA clearance obtained for Phase 3 dosing of Elate Ocular
- Manufacturing changes validated through extensive comparability program
- Ethics approvals secured in Australia and the US
- Trial protocols finalized following FDA consultation
- Initiation contingent on securing further funding
Regulatory Milestone Achieved
Cambium Bio Limited (ASX – CMB), a clinical-stage regenerative medicine company based in Sydney, has announced a significant regulatory achievement. The company has cleared all U.S. Food and Drug Administration (FDA) requirements to commence patient dosing in its pivotal Phase 3 clinical trials for Elate Ocular®, its lead biologic candidate targeting moderate to severe dry eye disease (DED).
This clearance follows a rigorous review process, including a Type C meeting with the FDA in January 2024, where the agency requested additional comparability data to address manufacturing changes made after the Phase 2 study. These changes notably included the introduction of a pathogen inactivation step, aligning with FDA guidelines for blood-derived therapeutics like Elate Ocular®.
Extensive Preparations Underpinning Progress
Over the past 18 months, Cambium Bio has undertaken an extensive Chemistry, Manufacturing and Controls (CMC) comparability program. This included validating a potency bioassay and producing current Good Manufacturing Practice (cGMP) drug product batches for use in the upcoming Phase 3 trials. The company has also secured ethics approvals in both Australia and the United States and finalized the trial protocol in close collaboration with the FDA.
Dr Neera Jagirdar, Cambium Bio’s Vice President of Clinical Development, expressed optimism about this milestone, highlighting the potential impact of Elate Ocular on millions of patients suffering from dry eye disease, a condition with limited effective treatment options.
Funding the Next Critical Stage
While regulatory clearance is a crucial step forward, the initiation of the Phase 3 trials; named CAMOMILE-2 and CAMOMILE-3; is contingent upon securing additional financing. Cambium Bio is actively engaged in discussions with strategic investors and capital markets participants to fund this next phase of development.
The successful commencement of these trials will be pivotal not only for Cambium Bio’s clinical pipeline but also for its valuation and future commercial prospects. Investors will be watching closely for updates on funding and trial progress as the company moves toward potentially transformative therapies in ophthalmology.
Bottom Line?
Cambium Bio’s Phase 3 journey begins, but financing remains the gatekeeper to progress.
Questions in the middle?
- When will Cambium Bio secure the necessary funding to start Phase 3 dosing?
- How might Elate Ocular’s Phase 3 results impact the dry eye disease treatment landscape?
- What are the potential risks if manufacturing changes affect trial outcomes?