Adverum Biotechnologies initiates phase 3 ARTEMIS trial evaluating ixoberogene soroparvovec (Ixo-vec) in patients with wet AMD

According to the company, Ixo-vec utilizes a proprietary vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. It is designed to be administered as a one-time intravitreal injection.¹ The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation for Ixo-vec in 2024.

The ARTEMIS phase 3 study (NCT06856577) will evaluate a single administration of Ixo-vec (6E10 vg/eye) compared to aflibercept (2mg) every 8 weeks in approximately 284 patients with wet AMD. Treatment-naïve, as well as previously treated patients, will be included. The company stated that the primary endpoint is mean change from baseline in best corrected visual acuity (BCVA) at one year (average of weeks 52 and 56) with a non-inferiority margin of -4.5 letters.

Per FDA guidance, patients will receive 3 loading doses of aflibercept prior to receiving Ixo-vec.

Sean Adrean, MD, partner, Retina Consultants of Orange County, and Carl Danzig, MD, Rand Eye Institute, both investigators for ARTEMIS, commented on the trial in a press release from the company.¹

“When designing registrational trials for patients with wet AMD, it’s not always feasible to study the therapeutic agent in a patient population that closely represents the real world. Adverum’s inclusion in ARTEMIS of both treatment-naive and treatment-experienced patients is intended to address a broad patient population, including those with the highest treatment burden,” said Adrean. “Based on its design, I expect the data coming out of the ARTEMIS trial will be highly informative and answer the key question of how Ixo-vec is expected to perform in those patients with high injection burdens and would most benefit from gene therapy.”

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Source: Ophthalmolgy Times