Harrison SA et al. Abstract L02. Published in: Liver Meeting Digital Experience; November 12-15, 2021 (virtual meeting).
Harrison SA et al. Abstract L02. Published in: Liver Meeting Digital Experience; November 12-15, 2021 (virtual meeting).
According to a speaker at The Liver Meeting Digital Experience, Vonafexor can significantly reduce liver fat content and improve biochemical and imaging markers of liver inflammation and kidney function.
Stephen A. Harrison, MD, medical director of the Pinnacle Clinical Research Center in San Antonio, Texas, said: "In week 12, patients with hypothetical fibrosis received bone effect therapy or 100 mg and 200 mg, which achieved a reduction in liver fat. The main end point." During the presentation.
"Non-invasive fibrous inflammation markers continue to improve. Through this mechanism, [glomerular filtration rate (GFR)] improvement may have some clinical benefits for renal function.
"The dual effects seen in studies of non-invasive liver function improvement and renal function improvement support further clinical and pathophysiological studies in this population," Harrison added.
The Honorary President of the University of Oxford Harrison and colleagues randomly assigned 96 patients with phenotype 2 or 3 fibrosis NASH to receive daily oral placebo (PBO, n = 32) or vonafexor 100 mg (n = 31) or 200 mg (n = 33) ) 12 weeks. The patient’s liver has an absolute fat content of 10% or higher, a liver stiffness of 8.5 kPa or higher on transient elastography, or a previous biopsy confirmed NASH.
At week 12, patients given vonafexor had a significant reduction in absolute liver fat content (–6.3% for 100 mg, –5.5% for 200 mg, and –2.3% for placebo; P <.001). Harrison pointed out that 58% of patients in the 100 mg group had an absolute reduction of more than 5% in liver fat content, compared with 22% in the placebo group.
The results showed that 50% of vonafexor-treated patients had a relative reduction of 30% or more in liver fat compared with 13% of placebo patients. Patients receiving vonafexor had an average reduction in alanine aminotransferase of 26%, compared with 13% in the placebo group. In patients treated with Vonafexor, the gamma-glutamyltransferase decreased rapidly and continuously by an average of 42% (P <.001).
Harrison pointed out that T1, corrected for liver fibrosis markers, was reduced by 81 milliseconds in patients treated with 100 mg of vonafexor, compared to 10 milliseconds in the placebo group (P <.001). The estimated GFR of the vonafexor 100 mg group improved significantly [5.6 mL/min/1.73 m2] on average, while the eGFR of the placebo group decreased [–2.8 mL/min/1.73 m2].
In addition, during the 12-week treatment period, 76% of patients receiving vonafexor had an increase in eGFR of less than 0.1 mL/min/1.73 m2, while 66% of patients receiving placebo had a decrease in renal function. Researchers observed a 34% increase in low-density lipid cholesterol (LDL-C). After adjusting the dose of statins, the LDL-C level was standardized to 70 mg/dL.
"When we looked at body weight and waist circumference, we found that at week 12, compared to placebo, both doses had an effect on body weight and waist circumference was reduced, but there was no difference between the two doses of vonafexor." Harrison said.
According to Harrison, 9% of patients discontinued vonafexor 100 mg treatment due to itching. Harrison and colleagues did not report any level 2 or higher alanine aminotransferase elevation. There are five serious adverse events reported, but they have nothing to do with drugs.
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