Adverum Biotechnologies, Inc. (NASDAQ: ADVM) stock is in a bull market following the announcement of positive clinical trial findings. After rising 7.97% the previous day to close at $9.48, ADVM shares had a 6.12% advance during the most recent pre-market session, finishing at $10.06.
Positive Findings from the LUNA Phase 2 Study
Promising findings from the 26-week intermediate analysis of the current LUNA Phase 2 study of Ixo-vec in patients with wet age-related macular degeneration (AMD) were released by Adverum Biotechnologies (ADVM).
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Dr. Charles Wykoff presented his findings in Stockholm, Sweden during the 42nd Annual Meeting of the American Society of Retinal Specialists. The 26-week analysis indicated that Ixo-vec demonstrates a potential best-in-class product profile, offering a favorable safety profile and a leading proportion of patients free from injections.
Patient Preferences and Future Outlook
ADVM’s pre-specified Patient Preference Survey, revealed for the first time, supports the company’s long-standing belief that patients prioritize long-term vision preservation and freedom from injections, undeterred by corticosteroid prophylaxis.
Over the next few quarters, Adverum Biotechnologies plans to present additional data at significant nine-month and one-year intervals. In the OPTIC study, nearly all patients who were injection-free at one year continued to be injection-free beyond three years.
Recent data has shown that up to 42% of patients discontinue treatment for wet AMD after three years due to the difficulty in adhering to a regimen of frequent intravitreal injections, resulting in suboptimal vision outcomes.
This highlights a significant unmet need for longer-acting anti-VEGF therapies. Consistent with preclinical data, the LUNA landmark analysis demonstrated that the lower 6E10 dose reduced inflammation while maintaining clinical activity, significantly reducing the treatment burden for many patients compared to the standard of care.
Protocol Amendments and Future Implications
Importantly, inflammation thus far appears clinically manageable and responsive to local corticosteroids, which are well tolerated and routine to administer. As previously reported in February 2024, Adverum Biotechnologies implemented a protocol amendment to extend the Ozurdex-containing regimens with a course of difluprednate drops.
Due to this protocol amendment, extending prophylaxis beyond the 26-week interim analysis for some patients, 35.6% of patients in the Ozurdex + difluprednate prophylactic arm have not completed the scheduled regimen as of the 26-week interim analysis data cut-off date, limiting the ability to fully evaluate this prophylactic arm at the interim analysis.
