Summary:
The upcoming readout from ETNB includes Phase 2b data from the pegozafermin trial in NASH. This is a Suspected Mover for Q1 2023!
No Phase 2b data has been reported yet from the ENLIVEN trial, but previous Phase 1b/2 data was reported throughout 2020 and 2021
Click below and sign up for free to see other upcoming Suspected Movers!
Already a paid BPIQ member? See our full list of February Big / Suspected Movers HERE. Learn more here to subscribe.
ETNB Readout
Pegozafermin is in a Phase 2b trial in NASH. This trial started in 2021 and so far no data has been reported. Previously, Phase 1b/2a data was reported throughout 2020 and 2021 at multiple conferences including ENDO 2021 and AASLD 2021, and topline data was reported January 24, 2022. This positive data showed that 63% of patients achieved 2-point or greater improvement in NASH without worsening of fibrosis. There were clinically meaningful improvements on the registration enabling endpoints of NASH resolution (32%) and fibrosis improvement (26%). After interim data from the Phase 1b/2a trial was reported previously, the Phase 2b ENLIVEN trial was allowed to initiate in June 2021. See Figures 1 & 2 (below) for more info from the Phase 1b/2a trial.
FIG. 1
FIG. 2
The Phase 2b ENLIVEN trial is evaluating several doses of subcutaneous injection of Pegozafermin against a placebo subcutaneous injection. The dual primary outcomes are to determine the number of participants with resolution of NASH without worsening of fibrosis and number of patients with at least 1 stage decrease in fibrosis stage with no worsening of NASH, both measured at 24 weeks. These endpoints are very common in NASH trials including the Phase 3 MDGL MAESTRO-NASH trial, Phase 3 ICPT REGENERATE trial, and Phase 2b AKRO HARMONY trial. See our previous MDGL article HERE for deeper analysis of these three trials.
It will be very interesting to see how the ENLIVEN data compares to these previous trials, especially to the AKRO HARMONY trial data. Both AKRO's Efruxifermin and ETNB's Pegozafermin are FGF21 analogs. The Phase 2b AKRO data showed improvement in fibrosis with no worsening of NASH and reduction of NASH with no worsening of fibrosis. However, compared to the ICPT and MDGL trials, the AKRO trial had the highest placebo rate and greatest occurrence of diarrhea and nausea adverse events. See Figure 3 for the trial design of the Phase 2b ENLIVEN trial.
FIG. 3
See our full previous NASH free blog article HERE that gives more info on upcoming NASH readouts, as well as Table 1 for brief info on these upcoming readouts. Subscribe to see even more info on these companies that are back in the spotlight after subscribing. Learn more HERE about subscribing.
Table 1. Upcoming NASH readouts
ETNB was a popular ticker held by many hedge funds during the last two quarters that we have been analyzing hedge funds. Six hedge funds held ETNB in Q3 2022 and 7 held ETNB in Q4 2022. Octagon Capital and Deep Track Capital added ETNB in Q4, and BVF sold ETNB in Q4. See more about hedge funds here: sign up for free to get the analysis sent straight to your inbox or become a paid subscriber for the full analysis.
We look forward to the Q1 2023 readout of Pegozafermin as well as the many other readouts in NASH coming this year!
This article is NOT legal, investment or tax advice. Please do your own diligence before making any investments.
Article history:
First published 2/22/23
#ETNB #Pegozafermin #VKTX #VK2809 #NGM #Aldafermin #HEPA #HEPACRV431 #AKRO #Efruxifermin #ICPT #Ocaliva #TERN #TERN101 #TERN501 #IVA #Lanifibranor #GALT #Belapectin #IONS #ION224 #ENLV #Allocetra #ARWR #AROHSD #GNFT #Nitazoxanide #MDGL #Resmetirom
If you are serious about investing in biotech stocks BPIQ is the research companion that will take you to the next level.
Save yourself time by accessing our database of over 550 companies, 1,800+ of their drug assets, and tools including: Catalyst Calendar, Big Movers, Company Pipelines, and more!
See what our members are saying about us:
Mike from United States
“Really loving the site over the competitor... like the layout and speed over the competition...like the individual pages for each drug/treatment”
Carl from United States
“I like your service. I haven’t seen anyone else doing something similar...nothing like this available for retail.”
Essey from Canada
“Love what you’re doing, this website is awesome.”
James from United States
Great site and I see it’s a family run business, great job.”
Kommentare