AstraZeneca Launches Phase 3 Trial of ALXN2220 (NI006) in China for ATTR Cardiomyopathy
AstraZeneca
Biopharmaceutical Manufacturer
Recently, according to the Chinese Drug Clinical Trial Registration and Information Disclosure Platform,AstraZeneca（AstraZeneca）Officially LaunchedALXN2220 Injection(Alias NI006)An international multicenter Phase 3 clinical study, which also includes the China region. The study targets adult patients diagnosed with wild-type or hereditary transthyretin-mediated amyloidosis cardiomyopathy.（ATTR-CM）Patient.
Screenshot source: Official website of the China Drug Clinical Trial Registration and Information Disclosure Platform
ATTR-CM is a fatal systemic disease that leads to heart failure and eventual death in patients. This occurs when ATTR proteins misfold due to aging or genetic mutations, subsequently depositing as amyloid fibrils in the myocardium and impairing organ function. Although therapies have been approved, these treatments only prevent amyloid accumulation, offering limited efficacy for patients with moderate to severe ATTR-CM.
ALXN2220Is an innovative anti-amyloid transthyretin（ATTR）Monoclonal antibodies, designed as "depleting agents" for cardiac amyloidosis, bring new hope for treatment in these patients.This antibody can specifically target misfolded transthyretin and clear amyloid fibril deposits in the heart, offering hope for effective treatment of patients with advanced ATTR-CM.Preclinical models have demonstrated its potential to clear pathogenic ATTR.
Screenshot source: PharmaCloud Global Drug R&D Database
In March 2022, Alexion, a subsidiary of AstraZeneca, entered into a collaboration with Neurimmune to jointly advanceALXN2220The research and development and commercialization. According to the agreement, Alexion will be responsible for subsequent clinical development and commercialization, while Neurimmune will receive corresponding upfront and milestone payments.
Currently, AstraZeneca has launched a Phase 3 clinical study in China targeting ATTR-CM patients, aiming to evaluateALXN2220The efficacy and safety. This study adopts a randomized, double-blind, placebo-controlled, multicenter design, with medication administered once a month for 24 months. The primary endpoint is the difference in the composite of all-cause mortality and cardiovascular clinical events.
ALXN2220The phase 1 clinical study was published last year in The New England Journal of Medicine. The study randomly assigned 40 patients to receiveALXN2220Or placebo treatment, the results showedALXN2220At the highest test dose, it still maintained good safety, with no obvious dose-limiting toxicity or serious adverse reactions observed. Meanwhile, cardiac amyloid deposits in patients significantly decreased within 12 months, and levels of related biomarkers were also reduced.
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