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

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Adverum Biotechnologies has initiated its ARTEMIS phase 3 study to evaluate the efficacy and safety of ixoberogene soroparvovec (Ixo-vec) for patients with neovascular (wet) age-related macular degeneration (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 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.”

“Delivering continuous levels of aflibercept to reduce treatment burden and improve visual outcomes may be even more profound in treatment-naïve patients,” said Danzig. “In OPTIC and LUNA, Ixo-vec has demonstrated the ability to durably produce therapeutic levels of aflibercept with an acceptable long-term safety profile, suggesting a potential lifelong benefit with a therapy that is well tolerated. It’s a great pleasure to be a part of this registrational program, and I look forward to working with the Adverum team to generate data to more fully elucidate Ixo-vec’s therapeutical potential for my patients.”

ARTEMIS is the first of 2 planned phase 3 registrational trials to evaluate Ixo-vec in patients with wet AMD. AQUARIUS, the second study, will be conducted globally, and additional information will be shared at a later date, according to the company.

Reference:

1. Adverum Biotechnologies Initiates ARTEMIS Phase 3 Study Evaluating Ixo-vec for Wet AMD. Published March 3, 2025. Accessed March 3, 2025.https://www.globenewswire.com/news-release/2025/03/03/3036018/0/en/Adverum-Biotechnologies-Initiates-ARTEMIS-Phase-3-Study-Evaluating-Ixo-vec-for-Wet-AMD.html