REDWOOD CITY, Calif., June 24, 2022 (GLOBE NEWSWIRE) — Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, announced today Today the European Medicines (EMA) granted ADVM-022 Priority Drug Designation (PRIME) for the treatment of Wet Age-Related Macular Degeneration (Wet AMD). Adverum’s lead gene therapy candidate, ADVM-022, is a unique intravitreal injection (IVT) for the treatment of patients with wet AMD.
PRIME is a program launched by the EMA to strengthen support for the research and development of medicines targeting an important unmet medical need. This regulatory program offers developers of promising drugs enhanced interaction and early dialogue and is designed to optimize development plans and accelerate evaluation by ensuring that these drugs reach patients as soon as possible. According to the EMA, developers of drugs eligible for PRIME can expect additional opportunities for scientific advice and be eligible for accelerated assessment at the time of marketing authorization application. Currently, only three eye therapies to date have earned PRIME designation out of 14 submissions.
“We are extremely pleased with the EMA’s decision to grant the ADVM-022 PRIME designation. Following the encouraging results seen in the OPTIC trial in wet AMD, our PRIME designation recognizes the vast potential of ADVM-022 and is based in part on our test subjects now having sustained aflibercept expression for three years with stable disease and maintained central subfield thickness and visual acuity long term after a single IVT injection,” said Laurent Fischer, MD, President and CEO of Adverum Biotechnologies, “The current standard of care in wet AMD, a highly prevalent disease, requires frequent injections of vascular endothelial growth factor (anti-VEGF) into the the eye and poses a lifelong burden to many patients and their caregivers.We believe the ADVM-022 has the potential to provide a durable, safe and cost-effective in-office treatment option that meets the b needs of these patients and their families, as well as retina specialists and healthcare systems around the world. We look forward to reaping the benefits that PRIME offers us as we continue to develop the ADVM-022 in areas of high unmet need. »
A Phase 2 study in wet AMD is planned to investigate the 2 x 10^11 vg/eye dose and a new lower dose of 6 x 10^10 vg/eye of ADVM-022, along with new steroid regimens enhanced prophylactics, including local steroids and a combination of local and systemic steroids. Adverum expects to dose the first patient in Q3 2022.
About Wet Age-Related Macular Degeneration
Wet AMD, also known as neovascular AMD or nAMD, is an advanced form of AMD, affecting approximately 10% of AMD patients. Wet AMD is a leading cause of blindness in patients over the age of 65, with a prevalence of approximately 20 million people worldwide living with the disease. The incidence of new cases of wet AMD is expected to increase significantly worldwide as populations age. AMD is expected to affect 288 million people worldwide by 2040, with wet AMD accounting for around 10% of these cases.
About ADVM-022 in Wet AMD
ADVM-022 is Adverum’s clinical-stage gene therapy product candidate under development for the treatment of wet AMD. ADVM-022 uses a proprietary vector capsid, AAV.7m8, carrying an aflibercept coding sequence under the control of a proprietary expression cassette. Unlike other ophthalmic gene therapies that require surgery to deliver the gene therapy below the retina (subretinal approach), ADVM-022 has the advantage of being delivered as a single in-office IVT injection and is designed to deliver long-term gene therapy. long-term efficacy and reduce the burden of frequent anti-VEGF injections, optimize patient compliance and improve visual outcomes for patients with wet AMD.
About Adverum Biotechnologies
Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious and rare eye diseases. Adverum is evaluating its novel gene therapy candidate, ADVM-022, as a single intravitreal injection for the treatment of patients with neovascular or wet age-related macular degeneration. For more information, please visit www.adverum.com.
Statements in this press release regarding events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to , statements regarding Adverum’s plans for a Phase 2 study in wet AMD to investigate the dose of 2 x 10^11 vg/eye and a new lower dose of 6 x 10^10 vg/eye of ADVM-022 , as well as new and improved prophylactic steroid regimens, including local steroids and a combination of local and systemic steroids, planned for the third quarter of 2022. Actual results could differ materially from those anticipated in these forward-looking statements due to various risks. and uncertainties, including but not limited to inherent risks: Adverum’s new technology, which makes it difficult to predict the timing of onset and the end of clinical trials; regulatory uncertainties; the results of early clinical trials are not always predictive of future clinical trials and outcomes; and the potential for future complications or side effects related to the use of ADVM-022. Additional risks and uncertainties facing Adverum are set forth under “Risk Factors” and elsewhere in Adverum’s filings and reports with the Securities and Exchange Commission (SEC), including Adverum’s Quarterly Report on Form 10-Q for the three months ended March 31, 2022 filed with the SEC on May 12, 2022. All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date on which they were made.
Vice President, Head of Corporate Strategy and External Affairs and Engagement
Adverum Biotechnologies, Inc.
Such. : 650-649-1358
Such. : 619-916-7620
E : email@example.com
Associate Director, Corporate Communications
Adverum Biotechnologies, Inc.
Such. : 650-649-1006
E : firstname.lastname@example.org