Clinical-stage biopharmaceutical company 89bio Inc (Nasdaq:ETNB) announced on Thursday that it has been granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) for pegozafermin in nonalcoholic steatohepatitis (NASH) patients.

This designation is based on positive data from the ENLIVEN Phase 2b trial, with discussions regarding the NASH Phase 3 program planned for Q4 2023.

Rohan Palekar, CEO of 89bio, highlighted the potential of pegozafermin as a leading FGF21 analog treatment option, citing strong histology data, superior tolerability and dosing convenience. BTD benefits include comprehensive FDA guidance, innovative development plan discussions, access to a scientific liaison and potential eligibility for Priority Review.

The BTD was backed by ENLIVEN Phase 2b trial data, where both the 44mg every-two-week (Q2W) and 30mg weekly (QW) doses met primary histology endpoints with high statistical significance. These doses also demonstrated significant improvements in various liver and metabolic markers. Notably, a descriptive analysis showed 45% of pegozafermin-treated patients achieving at least one-stage improvement in liver fibrosis without worsening NASH compared to one patient on placebo. Pegozafermin displayed a favorable safety profile consistent with prior studies.