Study Confirms Efficacy of Obeticholic Acid (OCA) Against NASH

A new study published in the Journal of Hepatology confirms the efficacy of Obeticholic Acid (OCA), a novel farnesoid X receptor agonist and antifibrotic agent against non-alcoholic steatohepatitis (NASH).

Phase III REGENERATE Trial

The Phase III REGENERATE trial originally reported results from an 18-month liver biopsy analysis involving OCA. The treatment demonstrated its efficacy, prompting further investigation. In this study, the potential of OCA was reaffirmed, providing hope for those battling this debilitating liver condition.

Study Objectives and Methodology

The study aimed to validate the previous findings and gather additional data to support OCA's effectiveness. A diverse panel of three pathologists independently evaluated digitized whole-slide images using the NASH Clinical Research Network scoring system. The primary endpoints were either:

• An improvement of at least one stage in fibrosis without worsening of NASH
• NASH resolution without worsening of fibrosis

Study Results

Among 931 participants, OCA demonstrated its potential with 22.4% achieving an improvement in fibrosis without NASH worsening, compared to only 9.6% on a placebo. Furthermore, 6.5% of those on OCA achieved NASH resolution without fibrosis progression, compared to 3.5% on the placebo.

Safety and Tolerability

Not only did OCA showcase its efficacy, but it also demonstrated a high degree of safety and tolerability. The study included data from 2,477 participants, and the incidence of treatment-emergent adverse events (TEAEs) and serious TEAEs was not substantially different across treatment groups. The most common TEAE reported was pruritus. Moreover, rates of hepatic, renal, and cardiovascular events were low and comparable across treatment groups.

Conclusion

These findings highlight OCA's potential to significantly impact the lives of patients with NASH-related liver fibrosis. Preventing fibrosis from progressing to cirrhosis or even reversing it is a critical goal in NASH treatment. OCA’s antifibrotic effects, proven effectiveness, and favorable safety profile offer hope for patients dealing with this challenging condition.

Source

Sanyal, A. J., Ratziu, V., Loomba, R., Anstee, Q. M., Kowdley, K. V., Rinella, M. E., Knapple, W., Lawitz, E. J., Abdelmalek, M. F., Shiff, S. J., Sawhney, S., Capozza, T., … Younossi, Z. M. (2023). Results from a new efficacy and safety analysis of the REGENERATE trial of obeticholic acid for treatment of pre-cirrhotic fibrosis due to non-alcoholic steatohepatitis. Journal of Hepatology, 79(5), 1110–1120. https://doi.org/10.1016/j.jhep.2023.07.014