Pegozafermin Enters Phase 3 Clinical Trial Program for MASH, Fibrosis
The phase 3 ENLIGHTEN program will consist of 2 phase 3 trials evaluating the safety and efficacy of pegozafermin in patients with MASH.
Source: hcplive.com
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89bio Reaches Alignment with the FDA and EMA on Phase 3 Program for Pegozafermin in Nonalcoholic Steatohepatitis (NASH); Program Initiation Planned in the First Half of 2024
—Alignment reached on key elements of the NASH development strategy, including accelerated approval pathway for both F4 and F2-F3 NASH patients using histology— —Outcomes trial in F4...
Source: marketscreener.com
Pegozafermin Shows Sustained Benefit for NASH in Phase 2b Extension Study
Results from the 24-week extension period of the phase 2b ENLIVEN trial showed sustained improvements in liver fat, fibrosis, and inflammation among those treated with 30 mg weekly and 44 mg biweekly pegozafermin.
Source: hcplive.com
89bio Announces New Positive Long-Term Data from the ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Nonalcoholic Steatohepatitis (NASH)
—Data at week 48 demonstrated that treatment with pegozafermin led to sustained statistically significant improvements across liver fat and non-invasive tests of liver injury/inflammation and...
Source: marketscreener.com
89bio Announces Additional Data from the ENLIVEN Phase 2b Trial of Pegozafermin in Patients with Compensated Cirrhotic (F4) Nonalcoholic Steatohepatitis (NASH) at AASLD The Liver Meeting® 2023
—Reductions in key non-invasive tests of liver inflammation and fibrosis support previously demonstrated fibrosis improvements across compensated cirrhotic patients at week 24— —A...
Source: marketscreener.com