Summary:
Phase 2b ETNB ENLIVEN data was reported today (3/22/23) & trial met primary endpoints
How does this data compare to previous NASH trial results?
What other NASH readouts are to come?
See our full article HERE after subscribing. learn more here!
ETNB was a BPIQ Big Mover for March and ended up moving 25% upon announcement of data! Get our FREE Big Mover article sent directly to your email for even more upcoming Movers!
ENLIVEN Data Reported
The ETNB Ph2b ENLIVEN trial evaluated pegozafermin to treat NASH. Topline data was reported today (3/22/23) and both primary endpoints were achieved with high statistical significance. This supports the advancement into a Phase 3 study. See our previous ETNB blog for more information on the Phase 2b trial design HERE.
The primary endpoints were the same as many other NASH studies: improvement of fibrosis without worsening of NASH and NASH resolution without worsening of fibrosis. The ENLIVEN trial evaluated pegozafermin at two dose levels: a weekly dose of 30mg (30mg QW) and an every-two-week dose of 44mg (44mgQ2W).
The primary endpoints of this trial showed:
30mg QW (all values placebo adjusted):
19% patients at least one stage fibrosis improvement (p=0.008)
21% patients NASH resolution (p=0.0009)
44mg Q2W (all values placebo adjusted):
20% patients at least one stage fibrosis improvement (p=0.0008)
24% patients NASH resolution (p=0.0005)
To see how this data compares to previous NASH trials see our BPIQ Pro forum HERE after subscribing.
Other exciting NASH readouts coming this year include: ICPT AdComm, VKTX Ph2 data, AKRO Ph2b data, MDGL NDA, TERN Ph2a data, and more! See Table 1 for all upcoming NASH readouts and check out our BPIQ Pro forum to see which of these are BPIQ Big Movers.
Table 1. Smid cap biopharmas w/ NASH assets
AKRO's Efruxifermin is a very interesting NASH asset that we are tracking as it has the same Mechanism of Action as ETNB's Pegozafermin. Both of these assets are FGF21 analogs. AKRO previously reported data in September 2022 from the Phase 2b HARMONY trial, and Phase 2b SYMMETRY data is expected in Q2 2023 (12 week data in patients w/ pre-cirrhotic NASH from texpansion Cohort D). Week 36 results from the SYMMETRY trial are also expected in Q4 2023. It will be interesting to see how the market reacts to these AKRO readouts and how the data compares to the current ETNB data!
2023 will be a very exciting year for NASH assets! For more information comparing the ETNB data to previous NASH readouts, see our full BPIQ Pro forum HERE after subscribing.
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