Sign in

    Alethia Young

    Research Analyst at Cantor Fitzgerald

    Alethia Young's questions to Adverum Biotechnologies (ADVM) leadership

    Alethia Young's questions to Adverum Biotechnologies (ADVM) leadership • Q4 2020

    Question

    Alethia Young of Cantor Fitzgerald inquired about the importance of secondary endpoints, such as the rescue regimen, from both the FDA's and physicians' perspectives, and asked if any interim analyses were planned for the pivotal trials before the 52-week endpoint.

    Answer

    CMO Aaron Osborne stated there will be no interim analyses for the registrational trials, with the primary endpoint analyzed at one year to support the BLA submission. He emphasized the importance of secondary endpoints, particularly OCT analyses, to demonstrate how the therapy's ability to maintain stability could reduce long-term complications like fibrosis and atrophy, which are linked to fluctuations seen with current treatments.

    Ask Fintool Equity Research AI

    Alethia Young's questions to Adverum Biotechnologies (ADVM) leadership • Q2 2020

    Question

    Alethia Young of Cantor Fitzgerald asked for details on the process and outcomes for patients when they discontinue topical steroid use, wanting to understand if it is a straightforward process for all patients or if some experience difficulties.

    Answer

    Chief Medical Officer Aaron Osborne described two patients in Cohort 1 who attempted to stop steroids: one was successful, while the other experienced a recurrence of inflammation that improved upon restarting the steroid eye drops. He noted this provided a key learning about tapering protocols. Dr. Arshad Khanani added that the majority of patients successfully come off the drops, and for those who require longer-term use, the burden is minimal compared to the significant benefit of avoiding frequent injections.

    Ask Fintool Equity Research AI

    Alethia Young's questions to Adverum Biotechnologies (ADVM) leadership • Q1 2020

    Question

    Alethia Young asked about the disease severity spectrum in DME versus AMD and its implications for the INFINITY trial. She also inquired about the company's strategic plans for the OPTIC program after the completion of the first four cohorts, particularly regarding future trial designs.

    Answer

    Chief Medical Officer Aaron Osborne clarified that the INFINITY trial targets a homogeneous population of patients with center-involving DME to ensure controlled data. Regarding future plans, President & CEO Leone Patterson and Dr. Osborne stated that they will await data from OPTIC's Cohort 4 and consult with the FDA before finalizing later-stage trial designs, but anticipate they will be randomized, controlled studies focused on visual acuity endpoints.

    Ask Fintool Equity Research AI

    Alethia Young's questions to Adverum Biotechnologies (ADVM) leadership • Q4 2019

    Question

    Alethia Young of Cantor Fitzgerald inquired about the enrollment progress for Cohort 4 of the OPTIC trial, the potential for clinical read-through from wet AMD data to the diabetic retinopathy (DR) indication, and how ADVM-022's durability offers an advantage over standard monthly therapies in DR.

    Answer

    President and CEO Leone Patterson confirmed active screening for Cohort 4 with strong investigator interest. She noted that safety data, particularly with the new steroid eyedrop regimen, would have read-through to the DR program. Chief Medical Officer Aaron Osborne added that anti-VEGF efficacy is generally consistent across wet AMD and DR. He highlighted that ADVM-022's key advantage is its long-term, sustained delivery, which is critical for managing a chronic disease like DR and can reduce the risk of sight-threatening complications that can occur between doses of short-acting therapies.

    Ask Fintool Equity Research AI