2023-06-28 20:20:00
Pegozafermin, which is being developed by 89BIO in the development of NASH (non-alcoholic steatohepatitis), which has regarding 130 clinical pipelines in operation around the world, is closely chasing the leading Resmetirom.
Resmetirom came one step closer to commercialization by presenting the results of phase 3 clinical trials that improved fibrosis and achieved remission of NASH, but Pegozafermine gained an advantage over Resmetirom in terms of effectiveness through phase 2 clinical trials.
According to the medical community on the 28th, the results of FGF21 analog pegozapermin administration to NASH patients conducted by researchers including Rohit Loomba of the NAFLD Research Center of the University of California Medical School in the United States were published in the international journal NEJM (DOI: 10.1056/NEJ Moa2304286).
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FGF21 is an endogenous metabolic hormone that regulates energy expenditure and glucose and lipid metabolism. It has a mechanism involved in regulating glucose and lipid homeostasis by acting on FGF (Fibroblast growth factor)21.
Pegozapermine showed a strong reduction of fatty liver and a clinically meaningful response in a significant proportion of patients. In addition, results suggesting changes in major liver markers related to NASH have been observed, and it is emerging as a drug that improves liver pathology and solves fundamental metabolic problems.
In the phase 2 clinical trial, 219 patients with biopsy-confirmed NASH and stage F2-F3 (moderate or severe) liver fibrosis were randomly assigned to receive 15/30 mg weekly, 44 mg every 2 weeks, or placebo every 2 weeks for 24 weeks.
The primary study end point was improvement in fibrosis (grade 0-4, higher score, worse), and remission rate and safety of NASH without NASH or worsening of fibrosis were also evaluated.
As a result of the analysis, the proportion of patients who met the criteria for improvement in fibrosis was 7% in the placebo group, 22% in the 15 mg pegozafermin group (14%p difference compared to placebo), 26% at 30mg (19%p difference), and 27% at 44mg (difference 19%p). With a difference of 20%p), pegozapermine was effective in a dose-dependent manner.
The percentage of patients who met NASH remission criteria was also 2% in the placebo group, 37% in the 15 mg pegozapermin group (difference 35%p compared to placebo), 23% at 30mg (difference 21%p), and 26% at 44mg (difference 24%p). %p) showed a similar pattern.
The most common adverse reactions associated with pegozapermine treatment were nausea and diarrhea.
The research team concluded, “Through the phase 2b clinical trial using pegozapermin, improvement in fibrosis was confirmed,” and “these results support the need for phase 3 clinical trials.”
In order to be approved by the FDA as a NASH treatment, one of the fibrosis improvement or NASH remission rate must be satisfied, but pegozappermine satisfies both of these, and it is said that it has confirmed its competitiveness even though it is only in phase 2 clinical trials.
In particular, looking at the response rate of the treatment group compared to the response rate of the placebo group, the fact that pegozapermine is ahead of Resmetirom in the rate of improvement of stage 1 or higher fibrosis (19/20% vs. 10/12%) is also a factor that highlights its competitiveness.
An official from the Society for the Study of the Liver said, “It is encouraging to see that various candidates are effective in improving fibrosis and remission of NASH in the absence of a suitable NASH treatment yet.” Each has a different mechanism and the method of administration is divided into oral and injection, so it remains to be seen what will be effective.”
He said, “Resmetirom has more than 300 people in each dose group, but clinical trials for other ingredients are relatively small, so the key is whether or not similar effects can be reproduced in additional clinical trials involving large-scale people.” , Attempts to divert candidates from the obesity treatment mechanism into NASH treatments are also continuing, so we have to wait and see the results.”
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