Adverum Biotechnologies announced the initiation of INFINITY, a phase 2, multicenter, randomized, double-masked, active comparator-controlled trial to assess a single intravitreal (IVT) injection of ADVM-022 in patients with diabetic macular edema (DME). The company also reported financial results for the first quarter ended March 31, 2020 and provided a corporate update.
The INFINITY trial will enroll approximately 33 patients and is designed to demonstrate superior control of disease activity following a single IVT injection of ADVM-022 compared to a single aflibercept injection, as measured by time to worsening of DME disease activity. Additional objectives include assessments of treatment burden, visual acuity, retinal anatomy and safety outcomes.
Participants in this double-masked trial will be randomized to one of three arms for their study eye treatment:
- Arm 1 will receive the higher dose of ADVM-022 at 6×1011 vg.
- Arm 2 will receive the lower dose of ADVM-022 at 2×1011 vg.
- Arm 3 will receive aflibercept at a dose of 2 mg.
“I’m thankful for the strong commitment and resilience our employees have exhibited towards advancing our pipeline despite the challenges of COVID 19,” Leone Patterson, president and chief executive officer, Adverum Biotechnologies, said in a company news release. “We continue to execute on our goal to develop and commercialize our novel gene therapy candidate ADVM-022 as a potential one-time treatment for patients with wet age-related macular degeneration (AMD) and DME, the two largest indications for anti-VEGF treatment. With the recent approval of our investigational new drug application for ADVM-022, we have initiated INFINITY in DME, a high-need subgroup of patients within the larger DR population. Additionally, we look forward to presenting data from all four cohorts of the OPTIC phase 1 trial for ADVM-022 in wet AMD by the end of this year.”
Aaron Osborne, MBBS, chief medical officer of Adverum Biotechnologies stated, “Over 30 million people are impacted by diabetes in the United States. DME affects approximately 5% of people with diabetes and is the most common cause of vision loss in people with diabetic retinopathy (DR). We believe that the exciting data seen to date for ADVM-022 in the ongoing OPTIC trial in wet AMD highlight this therapy’s transformative potential to deliver long-term control of serious retinal vascular diseases, including DME. INFINITY has been designed to provide robust, controlled data on ADVM-022 in DME and will be conducted at trial sites across the United States.”
- The U.S. Food and Drug Administration (FDA) approved Adverum’s IND application for ADVM-022 (AAV.7m8-aflibercept) for the treatment of DR. The company has initiated INFINITY, a phase 2, multi-center, randomized, double-masked, active comparator-controlled trial, to assess a single IVT injection of ADVM-022 in patients with DME, the most common cause of vision loss in patients with DR. INFINITY will enroll approximately 33 patients and is designed to demonstrate superior control of disease activity following a single IVT injection of ADVM-022 compared to a single aflibercept injection, as measured by time to worsening of DME disease activity. Additional objectives include assessments of treatment burden, visual acuity, retinal anatomy and safety outcomes.
- In early May, positive interim clinical data were presented from Cohorts 1-3 of the OPTIC Phase 1 dose-ranging clinical trial of ADVM-022 in patients requiring frequent anti-VEGF injections for wet age-related macular degeneration (wet AMD). Following a single IVT injection, ADVM-022 showed long-term durability beyond 1 year with zero rescue injections in Cohort 1. Additionally, early evidence from Cohort 3 suggested that a 6-week prophylactic regimen of steroid eye drops results in fewer adverse events and less inflammation, compared to a 13-day prophylactic regimen of oral steroids as used in Cohorts 1 and 2.
° Began dosing patients in April in Cohort 4 (n=9, dose 6 x 1011 vg and a 6-week prophylactic regimen of steroid eye drops).
° Data from all four cohorts expected to be presented by year-end.
- Scott Whitcup, MD, was appointed to Adverum’s Board of Directors. Dr. Whitcup has over 20 years of biopharmaceutical industry experience, with extensive expertise in drug development and regulatory approvals, including products for the treatment of patients with ocular disease.
- The company raised approximately $140.9 million in net proceeds from an underwritten public offering in February 2020.