– New knowledge spotlight {that a} single intravitreal injection of Ixo-vec can result in steady and protracted aflibercept expression by way of three years ensuing in fluid management supporting favorable imaginative and prescient outcomes, in addition to lowering therapy burden by an 81-98% discount in imply annualized anti-VEGF injections
– The 2×10^11 vg/eye (2E11) dose meaningfully decreased fluid quantity, together with a 93% discount in intraretinal (IRF) and 55% discount in subretinal fluid (SRF) from baseline to week 48
– The Phase 2 LUNA trial of Ixo-vec is underway, evaluating the 2E11 and 6×10^10 vg/eye (6E10) dose with enhanced prophylactic steroid regimens for the therapy of moist AMD topics
REDWOOD CITY, Calif., Sept. 30, 2022 (GLOBE NEWSWIRE) — Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage firm that goals to determine gene remedy as a brand new customary of take care of extremely prevalent ocular ailments, immediately introduced new analyses from the OPTIC examine treating moist age-related macular degeneration (moist AMD) in the course of the Late Breaking Developments portion of Retinal Subspecialty Day on the American Academy of Ophthalmology (AAO) 2022 Annual Meeting in Chicago, Illinois. New knowledge offered embody the consequences of ixoberogene soroparvovec (Ixo-vec, previously known as ADVM-022) on management of IRF and SRF after a single, in-office, intravitreal (IVT) injection in topics requiring frequent anti-VEGF injections for his or her moist AMD.
“We are pleased to see Ixo-vec’s effects on reducing intraretinal and subretinal fluid in treatment experienced patients in our post-hoc analysis of data generated from the OPTIC trial,” commented Richard Beckman, M.D., chief medical officer of Adverum Biotechnologies. “These data suggest that continuous and consistent expression of aflibercept has a stabilizing effect on the volume of both intraretinal and subretinal fluid, something that bodes well long-term. The connection between fluid fluctuations and long-term visual acuity is the subject of active research and several studies have demonstrated that less fluid fluctuation is associated with better visual outcomes.”
Data Highlights
- Following a single IVT injection of a 2E11 dose of Ixo-vec in OPTIC (n=15), there was a 93% and 55% discount in imply IRF and SRF quantity, respectively, from baseline to Week 48.
- The share of topics with dry SRF, throughout each the 6E11 and 2E11 dose teams, elevated by way of Week 48 with a 200% enhance in the 2E11 dose group (n=15).
- Importantly, 60% of OPTIC members receiving the 2E11 dose had dry IRF at Week 48, representing a 50% enhance from baseline.
“The meaningful drying of intraretinal fluid and subretinal fluid, as well as reduced exudative volatility observed in OPTIC is highly promising, as we have started to appreciate the relationship between these anatomical outcomes and the potential role on preservation of vision long term in patients with wet AMD,” said Justis P. Ehlers, M.D., who led the superior optical coherence tomography evaluation. “In addition, the increase in percentage of OPTIC patients achieving complete fluid resolution over time, through Week 48, at the 2E11 dose further reinforces the potential benefits of a single IVT injection of Ixo-vec.”
Patient enrollment and dosing are at present underway in LUNA, a double-masked, randomized, Phase 2 trial. Adverum expects to conduct the trial at roughly 40 websites in the U.S. and Europe. LUNA will consider Ixo-vec in topics with moist AMD who’re 50 years or older and have demonstrated a response to anti-VEGF therapy. Up to 72 topics will likely be randomized equally between the 2E11 dose and new decrease 6E10 dose and throughout 4 prophylactic steroid regimens. Specific regimens being evaluated embody topical difluprednate (Durezol®), IVT dexamethasone (Ozurdex®), or a mixture of both topical Durezol® or IVT Ozurdex® with oral prednisone, with the intention of creating a prophylactic routine with minimal want for irritation administration submit prophylaxis.
“The important learnings from the OPTIC trial, such as the association between anatomical improvements and the maintenance of vision and long-term durability, were particularly encouraging, especially as a physician who sees wet AMD patients on a daily basis,” mentioned Dante Pieramici, M.D., associate, California Retinal Consultants, OPTIC investigator, and presenter of the info at AAO. “I am excited to serve as an investigator in Adverum’s LUNA trial, and provide my wet AMD patients with a single, in-office IVT injection that can potentially serve as a functional cure to this debilitating disease.”
About Wet Age-Related Macular Degeneration
Wet AMD, often known as neovascular AMD or nAMD, is a sophisticated type of AMD, affecting roughly 10% of sufferers dwelling with AMD. Wet AMD is a number one explanation for blindness in sufferers over 65 years of age, with a prevalence of roughly 20 million people worldwide dwelling with this situation. The incidence of latest instances of moist AMD is predicted to develop considerably worldwide as populations age. AMD is predicted to impression 288 million folks worldwide by 2040, with moist AMD accounting for roughly 10% of these instances.
About LUNA Trial of Ixo-Vec in Wet AMD
Ixoberogene soroparvovec (Ixo-vec) is Adverum’s clinical-stage gene remedy product candidate being developed for the therapy of moist AMD. Ixo-vec makes use of a proprietary vector capsid, AAV.7m8, carrying an aflibercept coding sequence beneath the management of a proprietary expression cassette. Unlike different ophthalmic gene therapies that require surgical procedure to manage the gene remedy beneath the retina (sub-retinal strategy), Ixo-vec is designed to be administered as a one-time IVT injection in the workplace, ship long-term efficacy, scale back the burden of frequent anti-vascular endothelial development issue (VEGF) injections, optimize affected person compliance, and enhance imaginative and prescient outcomes for sufferers with moist AMD. Ixo-vec acquired PRIME designation from the European Medicines Agency in June 2022.
The LUNA trial is a multicenter, double-masked, randomized, parallel-group Phase 2 examine evaluating two doses of Ixo-vec, the 2×10^11 vg/eye dose and a brand new, decrease 6×10^10 vg/eye dose, in moist AMD. The trial is designed to randomize as much as 72 members equally throughout two doses and 4 prophylactic steroid regimens in roughly 40 websites in the U.S. and Europe.
About Adverum Biotechnologies
Adverum Biotechnologies (NASDAQ: ADVM) is a clinical-stage firm that goals to determine gene remedy as a brand new customary of take care of extremely prevalent ocular ailments with the aspiration of creating practical cures to revive imaginative and prescient and forestall blindness. Leveraging the analysis capabilities of its proprietary, intravitreal (IVT) platform, Adverum is creating sturdy, single-administration therapies, designed to be delivered in physicians’ places of work, to remove the necessity for frequent ocular injections to deal with these ailments. Adverum is evaluating its novel gene remedy candidate, ixoberogene soroparvovec (Ixo-vec, previously known as ADVM-022), as a one-time, IVT injection for sufferers with neovascular or moist age-related macular degeneration. By overcoming the challenges related to present therapy paradigms for these debilitating ocular ailments, Adverum aspires to remodel the usual of care, protect imaginative and prescient, and create a profound societal impression across the globe. For extra info, please go to www.adverum.com.
Forward-looking Statements
Statements contained in this press launch relating to occasions or outcomes which will happen in the longer term are “forward-looking statements” inside the that means of the Private Securities Litigation Reform Act of 1995. Such statements embody however usually are not restricted to statements relating to the potential advantages of Ixo-vec and the timing of preliminary knowledge from the LUNA trial evaluating the identical. Actual outcomes may differ materially from these anticipated in such forward-looking statements because of varied dangers and uncertainties, together with dangers inherent to, with out limitation: Adverum’s novel expertise, which makes it tough to foretell the timing of graduation and completion of scientific trials; regulatory uncertainties; enrollment uncertainties; the outcomes of early scientific trials not all the time being predictive of future scientific trials and outcomes; and the potential for future problems or unintended effects in reference to use of Ixo-vec. Additional dangers and uncertainties dealing with Adverum are set forth beneath the caption “Risk Factors” and elsewhere in Adverum’s Securities and Exchange Commission (SEC) filings and reviews, together with Adverum’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2022 filed with the SEC on August 11, 2022. All forward-looking statements contained in this press launch communicate solely as of the date on which they had been made. Adverum undertakes no obligation to replace such statements to mirror occasions that happen or circumstances that exist after the date on which they had been made.
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