89bio, Inc. (NASDAQ: ETNB) shares experienced a noteworthy surge of 10.06% on Tuesday, concluding the trading session at $9.96. This upswing in 89bio’s stock value was spurred by a pivotal regulatory meeting.
In a recent development, 89bio (ETNB) disclosed the successful conclusion of an End-of-Phase 2 Meeting with the U.S. Food & Drug Administration (FDA), signaling a significant stride in advancing pegozafermin into Phase 3 trials for Non-Alcoholic Steatohepatitis (NASH).
The comprehensive program encompasses two Phase 3 trials targeting NASH patients, with ENLIGHTEN-Cirrhosis enrolling those with compensated cirrhosis (F4) and ENLIGHTEN-Fibrosis enrolling patients with fibrosis stage F2-F3. Anticipated timelines project the initiation of the F2-F3 trial in the first quarter and the F4 trial in the second quarter of 2024.
Encouragingly, initial counsel from the European Medicines Agency (EMA) closely echoed the sentiments conveyed by the FDA. 89bio has successfully aligned with both regulatory bodies regarding the developmental trajectory for pegozafermin in NASH, introducing an innovative clinical trial approach specifically tailored for F4 patients.
The FDA has granted approval for an accelerated pathway in F4 patients, utilizing histology for the trial’s outcomes segment. Additionally, the FDA has sanctioned modified definitions for certain clinical outcomes, potentially expediting the trial’s readout timeline. The agency has also given the green light for a trial in F2-F3 patients, employing histology as an endpoint for accelerated approval.
Notably, the FDA has endorsed 89bio’s strategic decision to leverage safety data from its ongoing SHTG Phase 3 program, obviating the need for a separate safety study.
The forthcoming ENLIGHTEN program is poised to comprise two randomized, double-blinded, placebo-controlled Phase 3 trials, dedicated to assessing the efficacy and safety of pegozafermin in NASH patients. Both ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis trials will include a substantial number of patients on stable doses of GLP-1 based therapies.
The trials will scrutinize data from these patients to gauge the potential additional benefits of incorporating pegozafermin alongside existing therapies. Utilizing the successful three-panel consensus biopsy reading methodology from the ENLIVEN trial, both baseline and primary endpoint biopsy reads will be conducted.
Patients are anticipated to self-administer pegozafermin through the proposed commercial liquid formulation, administered via a single subcutaneous injection.