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– According to the latest analysis, the company is revising the ADVM-022 development plan, focusing on Wet AMD and low dose (2 x 10^11 vg/eye and lower); No longer planning and developing for DME——
– The company will host the conference call and webcast today at 1:30 PM Pacific Time / 4:30 PM Eastern Time-
Redwood City, California, July 22, 2021 (Global News Agency)- Adverum Biotechnology Company (Nasdaq:ADVM), a clinical-stage gene therapy company, for the unmet medical needs of the eye and rare diseases, today provides the latest information on the development plan of ADVM-022. Previously, it comprehensively reviewed the INFINITY clinical trial for patients with diabetic macular edema (DME). Available data) and OPTIC clinical trials for patients with wet AMD. Research data shows that there are significant differences in safety between the two patient groups and between low dose (2 x 10^11 vg/eye) and high dose (6 x 10^11 vg/eye). After observing dose-limiting toxicity (DLT) in DME patients at high doses (6 x 10^11 vg/eye) that was not previously seen in ocular gene therapy or anti-VEGF therapy, Adverum no longer plans for the future of DME Development. The company plans to evaluate ADVM-022, a single intravitreal (IVT) injection gene therapy, low-dose (2 x 10^11 vg/eye and lower) and alternatives in future wet AMD phase 2 clinical trials Prevention plan.
Wet AMD and DME have different pathophysiological causes and different risk factors. Although the underlying cause of DLT is still unclear, diabetic patients with DME usually have a variety of potential comorbidities, such as severe vascular disease, which may lead to inflammatory factors, which can lead to increased vascular permeability and damage to the blood-eye barrier. DME patients.I
As disclosed in late April 2021, Adverum immediately unmasked the INFINITY mask and began to closely monitor all patients who have received ADVM-022 treatment so far, as a suspected accidental serious adverse reaction occurred in the treatment eye of a DME patient (SUSAR ) The dosage of ADVM-022. Other patients in INFINITY who received a single high-dose ADVM-022 treatment, despite close monitoring and active treatment, experienced adverse events, including rapid, clinically relevant drop in intraocular pressure, ineffective against steroids, and requiring additional follow-up treatment . These events occurred 16-36 weeks after high-dose treatment. So far, no similar clinically relevant events have been observed in DME patients in INFINITY who received low-dose therapy, or in any wet AMD patients in OPTIC who received high-dose or low-dose therapy. The company works closely with the Data Monitoring Committee (DMC), its Scientific Advisory Board (SAB), leading retinal experts and researchers to closely manage patient care. All clinical trial sites and the US Food and Drug Administration (FDA) have been notified of these cases.
Laurent Fischer, MD, President and CEO of Adverum Biotechnologies, said: “Our main concern remains patient safety. “We are very grateful for the continued expertise shared by DMC, SAB, retinal experts and researchers to guide the best patient care. decision making. Gene therapy is a new, very promising but challenging field because we are committed to developing durable treatments for patients. Our team thanks all the patients and researchers who participated in our clinical studies for their key role in our efforts to change the treatment paradigm by developing disposable intravitreal gene therapies for patients. “
Dr. Fischer continued, “Based on the continuous and thorough review of the clinical and non-clinical data of ADVM-022, we are planning for the future development of wet AMD. We no longer plan to pursue DME. The data shows a significant difference between ADVM-022 and wet AMD. DME patients. Our full-time dedicated team and expert consultants are making unremitting efforts to better understand the root causes of events experienced by certain high-dose patients in INFINITY and the potential risk factors of these DME patients. After completion, according to our consultation with consultants and supervision Institutional analysis and discussion, we plan to conduct phase 2 clinical trials in patients with wet AMD to explore additional low-dose and alternative prevention options to support the best way to safely provide ADVM-022 to patients.”
“By working together, DMC, SAB, researchers, leading experts and Adverum have taken swift action to evaluate patients and provide the best care for them,” said Szilárd Kiss, MD, associate professor of ophthalmology and member of Adverum’s scientific advisory board. “in…
The full story can be found on Benzinga.com
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