Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EFX · 2 trials · 1 indication
Proportion of subjects who achieve ≥ 1 stage improvement in fibrosis (based on NASH CRN fibrosis score) and no worsening of steatohepatitis at Week 36. No worsening of steatohepatitis was defined as no increase in score for any of the 3 components of NAS. The evaluation of the NAS endpoint was calculated using the following 3 categorical features: steatosis \[0-3\], lobular inflammation \[0-3\], and hepatocellular ballooning \[0-2\]. NAS was derived as the unweighted sum of steatosis, lobular inflammation, and hepatocellular ballooning scores.
Main study. ANCOVA multiple imputation with treatment group and F1 fibrosis score (F1 vs F2-3) as factors and baseline hepatic fat fraction measured by MRI-PDFF as a covariate.
| Arm | Type | Description |
|---|---|---|
| EFX 28 mg (Main Study) | EXPERIMENTAL | - |
| EFX 50 mg (Main Study) | EXPERIMENTAL | - |
| Placebo (Main Study) | PLACEBO_COMPARATOR | - |
| EFX 50 mg (Cohort D) | EXPERIMENTAL | - |
| Placebo (Cohort D) | PLACEBO_COMPARATOR | - |
| EFX Dose 1 | EXPERIMENTAL | Main Study |
| EFX Dose 2 | EXPERIMENTAL | Main Study |
| EFX Dose 3 | EXPERIMENTAL | Main Study |
| Placebo | PLACEBO_COMPARATOR | Main Study |
| EFX Dose (Cohort C) | EXPERIMENTAL | - |
| Placebo (Cohort C) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| EFX | DRUG | Investigational drug, Efruxifermin |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Males and non-pregnant, non-lactating females between 18-75 years of age inclusive, based on the date of signing informed consent. * Main Study Only: Previous history or presence of Type 2 diabetes or 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated...
EFX is an investigational small molecule being developed for the treatment of nonalcoholic steatohepatitis (NASH), a form of fatty liver disease. It is currently in Phase 2 clinical development and has not been approved by the FDA.
EFX is being developed by Akero Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AKRO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with NASH.
EFX is in Phase 2 clinical development. Two Phase 2 trials have been completed, one involving 110 participants and another involving 213 participants, both in patients with NASH. The drug remains investigational and is not yet approved.
EFX has completed two Phase 2 clinical trials. The first, NCT03976401, enrolled 110 participants with histologically confirmed NASH in the United States and Puerto Rico. The second, NCT05039450, enrolled 213 participants with compensated cirrhosis due to NASH in the United States, Mexico, and Puerto Rico.
Yes, EFX is also known as efruxifermin. Both names refer to the same investigational drug being developed by Akero Therapeutics for the treatment of nonalcoholic steatohepatitis (NASH).