NGM hunts for light at end of tunnel as mid-phase NASH trial hits primary goal
BIOMARKER
1. NGM Biopharma has achieved positive results from a phase 2b study of aldafermin, a drug candidate for nonalcoholic steatohepatitis (NASH).
2. The trial, called ALPINE 4, involved 160 patients with liver disease who had compensated cirrhosis.
3. Aldafermin reduced enhanced liver fibrosis over the 48-week study when compared to a placebo, meeting the primary goal of the trial.
4. The drug did not achieve statistically significant results on a secondary endpoint monitoring improvement in liver fibrosis stage.
5. Previously, aldafermin failed in a phase 2b study called ALPINE 2/3, which focused on fibrosis stage improvement.
6. The drug was generally well tolerated with no treatment-related serious adverse events, consistent with previous studies.
7. Despite the main endpoint success, NGM announced that aldafermin will not advance without partnership support.
8. NGM reported a decline in cash and equivalents to $231 million as of March 31, down from $271.5 million at the end of 2022.
9. Revenue from a partnership with Merck & Co. decreased to $2.2 million for the first quarter of 2023, compared to $20.9 million for the same period a year earlier.
10. NGM is undergoing restructuring, reducing its headcount by 33% and reallocating resources towards its solid tumor oncology portfolio and drug discovery efforts.