Wave Life Sciences Ltd. (WVE), a clinical-stage biotechnology company, updated new positive data from the ongoing RestorAATion-2 trial evaluating WVE-006, its investigational candidate for the treatment of alpha-1 antitrypsin deficiency (AATD).
Following the news, WVE is surging by 4.69% to $6.70 in the pre-market.
WVE-006 and RestorAATion-2 trial Details
WVE-006 is a GalNAc-conjugated, subcutaneously delivered RNA editing oligonucleotide (AIMer).
RestorAATion-2 is an ongoing open-label Phase 1b/2a trial with three dose cohorts (each n=8), evaluating WVE-006 in single and multidose portions.
In the multidose portion, individuals received multiple doses of WVE-006, including 200 mg biweekly, 400 mg monthly, and 600 mg monthly, over 12 weeks, followed by 12 weeks of follow-up.
Key Findings
-In Pi*ZZ, a genetic subtype of AATD, individuals have Z-AAT aggregates in the liver, which can result in progressive liver disease. Treatment with WVE-006 led to dose-dependent reductions in circulating mutant Z-AAT from baseline following a single dose, reaching 47.3% (200 mg), 49.7% (400 mg), and 59.1% (600 mg).
-Also, there were further reductions in Z-AAT with seven doses of WVE-006, reaching 70.5% in the 200 mg biweekly dose cohort.
-Reduction in Z-AAT was similar when the dosing interval was extended, reaching 67.7% in the 400 mg monthly dose cohort with four doses.
-Data received support monthly subcutaneous dosing, with sustained editing at least 3 months after the last dose in both the 200 mg and 400 mg multidose cohorts.
-WVE-006 continues to be well tolerated, with a favourable safety profile, according to the firm.
The company expects FDA feedback on a potential accelerated approval pathway in mid-2026.
"We have now seen consistent results across multiple cohorts that reaffirm WVE-006's potential to protect the liver by reducing the toxic Z-AAT protein", and "We look forward to engaging with the FDA on our next phase of development," said Christopher Wright, Chief Medical Officer at Wave Life Sciences.
WVE has traded between $5.02 and $21.73 over the last year. The stock closed Monday's trade at $6.40, down 5.47%.
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