Aviceda Therapeutics, Inc.

Despite the fail, Aviceda still plans to test its lead asset in two sham-controlled phase 3 trials in 2026.\n Aviceda Therapeutics has hit a snag in its goal to deliver a new treatment for geographic atrophy (GA), an advanced form of dry age-related macular degeneration. The biotech’s lead asset, AVD-104, failed to beat Astellas’ Izervay (avacincaptad pegol) at slowing the rate of retina lesion growth, missing the primary endpoint of a phase 2 trial.The trial enrolled 300 patients with GA and treated them with monthly eye injections of either Izervay or AVD-104 at low or high doses.\"The study did not meet its primary endpoint, which was designed to assess non-inferiority,\" a company spokesperson told Fierce Biotech. \"No statistical differences in GA lesion growth rates were observed across the three study arms.\"AVD-104 led to no serious adverse events, Aviceda reported in a Dec. 15 release, with the most common side effect being eye floaters. AVD-104 is a nanoparticle adorned with polysialic acid, designed to bind to receptors on the surfaces of overactive immune cells like macrophages that cause eye inflammation in GA.Though it failed to top Izervay, AVD-104 did reduce the growth rate of GA lesions by 31% compared to previously published sham-treatment rates from Izervay’s phase 3 trial, according to Aviceda. The company described this finding as “clinically meaningful.” In addition, the company highlighted that patients given AVD-104 were able to read an average of 0.6 more letters in a visual acuity test after 12 months of treatment.“These results reinforce our belief that AVD-104 can provide meaningful functional vision benefit while reducing lesion progression, and has the potential to become a differentiated therapy addressing a significant unmet medical need for patients living with GA,” Aviceda CEO Jeffrey Nau, Ph.D., said in the release. Despite the failure, which Aviceda attributed to “imbalances in key baseline lesion characteristics across treatment arms,” the company still plans to test its lead asset in two sham-controlled phase 3 trials in 2026, according to the release. The Massachusetts-based biotech closed a $207.5 million series C in January to support its phase 3 vision.Aviceda was also testing the nanoparticle in a phase 2 trial for diabetic macular edema, but halted the study early due to “insufficient study drug supply and study funding constraints,” according to the clinicaltrials.gov database.GA has been a tough indication for pharma to crack. Roche blockbuster hopeful lampalizumab flopped in a critical phase 3 trial in 2017, with the Swiss pharma subsequently ditching the asset. Novartis scrapped its own GA candidate, acquired from Gyroscope Therapeutics, in September 2023 because of weak data.And in September 2024, Alkeus Pharmaceuticals reported that its oral candidate failed to reduce GA lesion growth in a phase 3 trial, with the company nevertheless declaring the results “clinically meaningful.”Apellis\' Syfovre (pegcetacoplan) was the first GA drug to break through, securing FDA approval in February 2023. However, the med was flagged by the agency for rare cases of severe eye inflammation that can lead to blindness just months later. Astellas picked up Izervay through the $5.9 billion acquisition of Iveric Bio in March 2023, garnering an approval of its own that August.Neither Izervay nor Syfovre is able to restore vision, and injections of both come with the risk of side effects like inflammation, bleeding and blurred sight.Outside of therapeutics, Science Corp. announced in October that its retinal implant was able to give GA patients some vision back in a clinical trial.Editor\'s note: This story was updated at 4:00 p.m. ET with a statement from Aviceda.

Aviceda Therapeutics is pushing forward with Phase 3 plans for its experimental eye drug despite failing a Phase 2b study in geographic atrophy. The mid-stage trial compared Aviceda’s AVD-104 to Astellas’ drug Izervay in patients with geographic atrophy (GA), the advanced stage of a leading cause of blindness called age-related macular degeneration (AMD). AVD-104 is designed to slow the progress of dry AMD. But in the Phase 2b study, it showed no statistical difference in its ability to reduce GA lesion area growth compared to monthly Izervay treatment. The company blamed the results on “imbalances in key baseline lesion characteristics across treatment arms.” An Aviceda spokesperson told Endpoints News that at the start of the study, the AVD-104 and Izervay groups weren’t “fully comparable on factors that can influence how quickly GA lesions enlarge,” which can impact the treatment-arm comparisons. Even though the trial missed its primary endpoint, Aviceda’s CMO David Callanan said in a press release that he was still “encouraged.” Both doses of AVD-104 reduced GA lesion growth rates when compared to previously completed placebo-controlled or natural history studies, Aviceda said. But it’s difficult to accurately compare data across trials. Aviceda also said there was “sustained improvement in mean best-corrected visual acuity” over its study period, and no drug-related serious side effects were observed in the AVD-104 patients. The most common side effect was floaters. “We are encouraged by the magnitude of visual acuity gains, including protection from significant vision loss, reduction in lesion growth relative to historical sham and expected natural history,” Callanan said in the news release. Aviceda said it will present the full data in 2026. It also plans on launching two randomized Phase 3 trials next year. Unlike the Phase 2b study, which compared AVD-104 to Izervay, the Phase 3s will make use of a fake comparator called a “sham” treatment. The final design of those studies is “underway,” the company said. The biotech raised $207.5 million in a Series C round at the beginning of this year, part of which it had earmarked for Phase 3 plans in geographic atrophy.

I-Mab Biopharma announced a slew of changes after the US market closed on Thursday, including acquiring a retinal disease drug, naming a new CFO, and planning a dual listing in Hong Kong. The Rockville, MD-based biotech also said it plans to change its name to NovaBridge Biosciences later this month. I-Mab is preparing to trade on the Hong Kong Stock Exchange by the end of the year, executive chair Wei Fu told Endpoints News . Fu is CEO of CBC Group, one of the leading healthcare asset management firms in Asia and a key backer of I-Mab. He was named I-Mab executive chair last month. The HKEX has become the go-to IPO market for biotech companies, with more than 40 Chinese biotechs submitting their pitches so far this year. To help with the listing, I-Mab brought on a CFO with HKEX expertise. Kyler Lei was previously head of capital markets at Sino Biopharmaceutical. Sino, which is listed on the HKEX, acquired LaNova Medicines earlier this year. I-Mab’s decision to pursue an HKEX listing comes about a year and a half after the company split its US and China businesses, citing R&D and operating expenses , among other reasons. Multiple executives departed shortly thereafter. With China’s biotech ecosystem attracting global attention, Fu believes that I-Mab can benefit from that interest, describing the drug development environment there as a “sustainable opportunity.” “Therefore, we try to repurpose I-Mab to service this need to bring the innovation out of that market, China, to serve the global patients,” he said. The biotech is also adopting a hub-and-spoke model, in which assets are housed in individual units to facilitate simpler dealmaking with pharma companies. The model has become more common following successful experiments at companies like Roivant Sciences and BridgeBio. The company said the spokes allow it to “maintain operational focus and agility.” In an interview, I-Mab CEO Sean Fu said the company will continue working on its internal pipeline, which includes three clinical-stage cancer drugs: “What we are providing is a commitment to continue to deliver on giva and the rest of the innovative assets in the I-O space,” he said. As part of the model, I-Mab created a subsidiary called Visara, and it pumped $37 million into the unit, which will serve as the basis for its foray into ophthalmology. The company plans to look for additional ophthalmology assets in China, Korea, the US and elsewhere, Wei Fu said. Visara acquired an experimental retinal disease drug from AffaMed Therapeutics and its partner AskGene Pharma for undisclosed terms. Known as VIS-101 (formerly AM712), the bifunctional biologic targets VEGF-A and ANG2. The experimental medicine has been through Phase 1 in patients with diabetic macular edema and neovascular age-related macular degeneration . It’s currently in a Phase 2 in China, I-Mab said. Another Western biotech recently licensed a VEGF and ANG2 candidate from a Chinese drug developer. Ollin Biosciences launched last month with $100 million to develop a bispecific from Innovent Biologics and another ophthalmology asset from VelaVigo. I-Mab and Ollin are both trying to develop therapies that can compete with Roche’s Vabysmo. Heading up the board at Visara is Emmett Cunningham, who is also on the boards of other ophthalmology companies like Aviceda Therapeutics and Eyconis, the Ascendis Pharma spinout.