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AbbVie and REGENXBIO announced a strategic partnership to develop and commercialize RGX-314, an investigational gene therapy for wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases.
AbbVie and REGENXBIO on Monday unveiled a partnership to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases.
According to the companies, RGX-314 is currently being evaluated in patients with wet AMD in a pivotal trial utilizing subretinal delivery, and in patients with wet AMD and DR in two separate Phase II clinical trials utilizing in-office suprachoroidal delivery.
The companies noted that under the collaboration, REGENXBIO will be responsible for completion of the ongoing trials of RGX-314. AbbVie and REGENXBIO will collaborate and share costs on additional trials of RGX-314, including the planned second pivotal trial evaluating subretinal delivery for the treatment of wet AMD and future trials.
Moreover, AbbVie will lead the clinical development and commercialization of RGX-314 globally. REGENXBIO shall participate in U.S. commercialization efforts as provided under a mutually agreed upon commercialization plan.
“We are committed to finding solutions for patients living with difficult-to-treat retinal diseases and to helping preserve and protect our patients from visual impairment and devastating vision loss,” Tom Hudson, MD, senior vice president, Research and Development, chief scientific officer, AbbVie, said in a statement. “In collaboration with REGENXBIO, we aim to make a remarkable impact for the millions of patients suffering from vision loss associated with retinal diseases.”
Kenneth T. Mills, president and chief executive officer of REGENXBIO, said AbbVie is a strong, complementary partner for REGENXBIO.
“We expect to leverage AbbVie’s global developmental and commercial infrastructure within eye care with our expertise in AAV gene therapy clinical development and deep in-house knowledge of manufacturing and production to continue the development of RGX-314,” Mills said in a statement.
During a conference call on Monday, Mills also lauded the qualities that AbbVie will bring to the partnership.
“We chose to partner with AbbVie, certainly due to their strength and their global commercialization reach and the fact that they have one of the largest eyecare franchises in the world,” he said during the call.
Under the terms of the agreement, AbbVie will pay REGENXBIO a $370 million upfront payment with the potential for REGENXBIO to receive up to $1.38 billion in additional development, regulatory and commercial milestones. REGENXBIO and AbbVie will share equally in profits from net sales of RGX-314 in the U.S. AbbVie will pay REGENXBIO tiered royalties on net sales of RGX-314 outside the U.S. In addition, REGENXBIO will lead the manufacturing of RGX-314 for clinical development and U.S. commercial supply, and AbbVie will lead manufacturing of RGX-314 for commercial supply outside the U.S.
The transaction is expected to close by the end of 2021, subject to the satisfaction of customary closing conditions, including applicable regulatory approvals.
REGENXBIO has begun ATMOSPHERE, a subretinal pivotal trial in neovascular AMD.
RGX-314 is being investigated as a potential one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions. RGX-314 consists of the NAV AAV8 vector, which encodes an antibody fragment designed to inhibit vascular endothelial growth factor (VEGF). RGX-314 is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina.1
Investigators will evaluate 2 doses of RGX-314 compared with monthly injections of ranibizumab in pseudophakic patients with a baseline VA of 20/32 to 20/160.
The study will enroll about 300 patients at 60 clinical sites. The primary end point is the mean change in BCVA relative to ranibizumab at week 54.
REGENXBIO is also conducting studies using the in-office SCS Microinjector to deliver RGX-314 to the suprachoroidal space in patients with neovascular AMD and diabetic retinopathy.
Upcoming results from these suprachoroidal programs will be announced for the phase 2 AAVIATE (neovascular AMD; NCT04514653) and ALTITUDE (diabetic retinopathy; NCT04567550) trials.
Penn JS, Madan A, Caldwell RB, et al. Vascular endothelial growth factor in eye disease. Prog Retin Eye Res. 2008;27(4):331-71.