AMD News – Adverum Biotechnologies (ADVM) Shares Higher; Releases Data From ADVM-022 Trials Following Complications
What is Going on with ADVM?
Adverum Biotechnologies (ADVM) has announced its long-term data from the OPTIC clinical trial of ADVM-022 single intravitreal (IVT) gene therapy. This is an experimental therapy intended to treat patients with diabetic macular edema. Specifically, the treatment can help patients who require frequent anti-VEGF injections to treat their neovascular or wet age-related macular degeneration (wet AMD). ADVM stock was trading 1.28% higher to $3.95 a share Monday morning following the data release.
As Laurent Fischer, CEO at Adverum Biotechnologies, says, ““The long-term OPTIC data show the potential for ADVM-022 to offer disease modifying treatment for patients with wet AMD.” However, this comes after complications experiences by one patient resulting in vision loss of the treated eye. It is unknown whether the treatment caused the vision loss or if the patients condition was the cause. Regardless, Adverum Biotechnologies has decided to unmask the study and proceed with more caution. Laurent Fischer states that, “Patient safety is our absolute priority and following the unexpected adverse event we reported this past week in a patient treated with the 6e11 high dose in the INFINITY study in diabetic patients with macular edema, we are unmasking the INFINITY study in order to analyze all data available and monitor every patient who has received our gene therapy. We are also working closely with our data monitoring committee and scientific advisors and conducting a thorough review of all the data from our ADVM-022 program. We will report our findings as the analysis progresses to inform next steps for development.”
What This Means for ADVM?
Adverum Biotechnologies’ shares are higher following the news as the company seems hopeful that the data may reflect the treatment’s success. Laurent Fischer says that,” In OPTIC, ADVM-022 with wet AMD has demonstrated durability out to two years with the ease of a single, in-office intravitreal injection. We believe that we are well within the therapeutic window with the 2e11 dose with 60% of patients supplemental injection free beyond one year. Additionally, the aflibercept protein levels at the 2e11 dose were within the modeled therapeutic range and sustained out to at least one year, consistent with levels observed 4-6 weeks after an aflibercept injection.”
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Adverum Biotechnologies Inc is a US-based clinical-stage gene therapy company. It develops gene therapy product candidates intended to provide durable efficacy by inducing sustained expression of a therapeutic protein. The company has primarily generated revenue through license, research and collaboration arrangements with its strategic partners. Its lead product candidate is ADVM-022 which is a single, in-office intravitreal (IVT) injection gene therapy designed to deliver long-term durability with treatment response, reduce the treatment burden of frequent anti-vascular endothelial growth factor (anti-VEGF) injections, and improve real-world vision outcomes for patients.