REDWOOD CITY, Calif. – Adverum Biotechnologies, Inc. (NASDAQ: NASDAQ:), a clinical-stage gene therapy company, announced results from its LUNA Phase 2 trial and long-term OPTIC study data, which suggest that its investigational gene therapy, Ixo-vec, may offer a sustained treatment option for wet age-related macular degeneration (wet AMD (NASDAQ:)). Ixo-vec is designed to be a one-time intravitreal injection, potentially reducing the frequency of treatments required for patients.
The LUNA trial evaluated two doses of Ixo-vec in 60 patients, showing that both maintained visual and anatomic endpoints through 52 weeks with significant reductions in treatment burden. The 6E10 dose demonstrated an 88% reduction in mean annualized anti-VEGF injections, with 54% of patients achieving injection freedom. The 2E11 dose resulted in a 92% reduction, with 69% of patients injection free.
In the OPTIC study, a long-term follow-up of 21 patients showed that the 2E11 dose provided stable therapeutic levels of aflibercept up to five years post-treatment, with an 86% reduction in annualized anti-VEGF injections through year four. Nearly half of the patients remained injection free for the entire four years.
No significant inflammation was reported in patients who received local steroid prophylaxis in the LUNA trial at week 52 or any subsequent visit, and all OPTIC patients were free of inflammation from the first year through the fourth year.
Adverum plans to advance the 6E10 dose with steroid eye drops into two Phase 3 registrational studies, with the initial ARTEMIS study expected to begin in the first half of 2025. The study will compare Ixo-vec to aflibercept in a broad patient population, including both treatment-naïve and treatment-experienced individuals.
The company reported a strong patient preference for Ixo-vec in a LUNA survey, with a majority favoring the gene therapy over previous treatments and willing to recommend it to others. Adverum’s cash position as of September 30, 2024, was $153.2 million, which is expected to fund operations into the second half of 2025, not including the completion of the ARTEMIS trial.
This information is based on a press release statement from Adverum Biotechnologies. Wet AMD is a leading cause of blindness in older individuals, and current treatments require frequent injections. Ixo-vec aims to reduce this burden and improve patient outcomes.
In other recent news, Adverum Biotechnologies has announced long-term clinical data for its gene therapy product, ixoberogene soroparvovec (Ixo-vec), aimed at treating age-related macular degeneration (AMD). The company reported 52-week results from its LUNA phase 2 study and 4-year data from the OPTIC trial. Ixo-vec has received Fast Track designation from the U.S. Food and Drug Administration, PRIME designation from the European Medicines Agency, and the Innovation Passport from the UK’s Medicines and Healthcare Products Regulatory Agency.
Adverum has also appointed Jason L. Mitchell as its new Chief Commercial Officer, a move expected to enhance Ixo-vec’s launch and commercialization. The company’s second quarter financial results for 2024 were strong, with earnings per share of ($0.89) surpassing both firm and consensus estimates.
Several analyst firms, including H.C. Wainwright, RBC Capital Markets, Oppenheimer, Mizuho (NYSE:) Securities, and Truist Securities, have provided their outlook on Adverum. H.C. Wainwright maintained its Buy rating and $30.00 price target, while RBC Capital Markets adjusted its price target to $10.00 from the previous $12.00. Oppenheimer kept its Outperform rating with a $28.00 price target, Mizuho Securities reduced its target to $20.00, and Truist Securities revised its target from $60.00 to $40.00. These are among the recent developments for Adverum Biotechnologies.
InvestingPro Insights
Adverum Biotechnologies’ recent announcement of promising results for its Ixo-vec gene therapy aligns with several key financial metrics and insights from InvestingPro.
According to InvestingPro data, Adverum’s market capitalization stands at $142.7 million, reflecting the company’s current valuation as it advances its clinical programs. This relatively modest market cap suggests potential for growth if Ixo-vec continues to show positive results in upcoming Phase 3 trials.
An InvestingPro Tip indicates that Adverum “holds more cash than debt on its balance sheet,” which is crucial for a clinical-stage biotech company. This strong cash position is consistent with the company’s reported $153.2 million in cash as of September 30, 2024, providing runway into the second half of 2025. However, another InvestingPro Tip notes that the company is “quickly burning through cash,” which is typical for biotechs in late-stage clinical development.
The company’s focus on Ixo-vec as a potential game-changer in wet AMD treatment is particularly important given that InvestingPro data shows a significant revenue decline of -72.22% in the last twelve months. This underscores the importance of successful clinical outcomes and potential commercialization of Ixo-vec for Adverum’s future financial health.
It’s worth noting that InvestingPro offers 11 additional tips for Adverum Biotechnologies, providing investors with a more comprehensive analysis of the company’s financial situation and market position.
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