Last updated 1/12/2023
Summary:
MDGL read out Phase 3 topline data on December 19, leading to a stock move of over +250%!
Many other NASH readouts have occurred since 2019, and NASH companies have made some big moves since Mid 2022
AKRO read out important data in September 2022 and ICPT reported REGENERATE data again in July 2022
How does data compare from these readouts, and what data is coming?
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Warning - this is a cross trial comparison, so it is more to compare interesting points from each trial, but should be taken with a grain of salt.
NASH has recently been back in the spotlight, as we previously mentioned in our NASH article. Soon after the publishing of our article, the Phase 3 MDGL data from the MAESTRO-NASH trial was posted. This data led to MDGL stock jumping 286%!
Additional Phase 2 and 3 trial data from other NASH companies have reported since 2019, multiple leading to big stock jumps as well. However, NASH companies still have run into difficulties. NASH trials can take years to complete (as we see with VKTX's slow trial progression), NASH has to be diagnosed with a liver biopsy, and endpoints are also measured by biopsies read by pathologists.
After the MDGL data, we wanted to compare the endpoint results with other recent NASH readouts.
See Table 1 for a comparison of trial dosing, primary endpoints, and adverse events from three big trial readouts in 2022: MDGL, AKRO, and ICPT. We will also briefly mention VKTX data from the NAFLD trial, as it led to the current ongoing NASH trial.
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Table 1. Comparison of recent NASH trial data
In this table we compared data from the Phase 3 REGENERATE trial from ICPT which focused on fibrosis due to NASH. A second Phase 3 trial from ICPT focused on cirrhosis due to NASH (REVERSE trial) but the trial did not meet the primary endpoint. REGENERATE topline data was first reported in February 2019, leading to a 6.1% stock move, however the company then received a CRL for the first NDA submission. New interim data from the study was then reported in August 2020, and the full new data package was reported July 7, 2022, leading to the new NDA submission on 12/23/22. Table 1 thus includes results from the July 2022 data, as it is the full data which was used for the NDA resubmission.
The December MDGL data was very impressive, there was highly statistically significant data in both endpoints: NASH resolution and fibrosis improvement. ICPT was only statistically significant with one endpoint: improvement of fibrosis without worsening of NASH. MDGL also saw a decrease in LDL-C levels of patients, whereas the ICPT trial increased LDL-C levels at first (because of the FXR agonist mechanism of action). ICPT Ocaliva did have less AEs than MDGL's Resmetirom, which had a high occurrence of diaarhea in patients taking Resmetirom.
VKTX Phase 2 data in NAFLD was reported in April 2019. There was a statistically significant median reduction in liver fat content in 53.8% of patients and 80% of patients experienced more than a 30% reduction in liver fat content at 12 weeks. No SAEs were reported for the trial.
Many data readouts are coming in the next year including from VKTX, ETNB, AKRO, and others. See our previous NASH post for details on these upcoming events. Several of these readouts have the same mechanism of action as Resmetirom (a THR agonist).
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