89bio, Inc. is advancing its lead product candidate, pegozafermin, a glycoPEGylated analog of fibroblast growth factor 21 (FGF21), through Phase 3 clinical trials for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). The company's strategic initiatives include ongoing clinical trials, regulatory milestones, and manufacturing collaborations to support the potential commercialization of pegozafermin.
Clinical Development and Regulatory Milestones
Pegozafermin has achieved significant regulatory milestones, including Breakthrough Therapy Designation from the FDA for MASH in September 2023 and PRIME designation from the EMA in March 2024. These designations were based on positive clinical data from the Phase 2b ENLIVEN trial, which demonstrated statistically significant improvements in key markers of liver health.
The Phase 3 ENLIGHTEN program includes two clinical trials, ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis, both initiated in 2024, targeting MASH patients with varying stages of fibrosis. Additionally, the Phase 3 ENTRUST trial for SHTG was initiated in the second quarter of 2023, with topline results expected in 2025. This trial is the first of two recommended Phase 3 trials for SHTG.
Financial Position and Manufacturing Expansion
89bio reported a loss from operations of $(151.9) million for the third quarter of 2024, an increase of $112.6 million compared to the same period in 2023, primarily due to higher research and development expenses. As of September 30, 2024, the company's cash, cash equivalents, and marketable securities totaled $423.8 million, which is expected to fund operations for at least one year.
To support the commercial supply of pegozafermin, 89bio entered into a collaboration agreement with BiBo Biopharma Engineering Co., Ltd. in April 2024 to construct a production facility in China. The company has committed an aggregate of $135.0 million towards this facility, with $81.0 million already paid.
Strategic Focus and Future Outlook
89bio is focused on the development and commercialization of pegozafermin for MASH and SHTG. The company is expanding its clinical, regulatory, quality, manufacturing, and commercialization capabilities to support these efforts. Looking ahead, 89bio plans to continue advancing its clinical development programs for pegozafermin, with expected topline results from the Phase 3 ENTRUST trial in SHTG anticipated in 2025. The company expects to incur significant expenses as it progresses its clinical trials, seeks regulatory approval, and prepares for potential commercialization.
