Scholarlink

Background and aims <p>Cirrhosis is a disease of impaired liver function and fibrosis caused by long-term liver damage. However, to date, no drugs have been approved to improve liver fibrosis. We report the results of a phase 2 study of S-005151 (generic name: Redasemtide), a partial peptide of High-Mobility Group Box 1 (HMGB1), in patients with chronic liver disease.</p> Approach and results <p>This single-center, non-randomized, single-arm, open-label study was performed in Japan in patients with chronic liver disease (cohort A: 5 patients, cohort B: 5 patients) caused by HCV, HBV, MASH, or alcohol, with MR elastography of ≥ 4&#xa0;kPa and Child–Pugh score up to 7 points. The primary endpoint was safety; secondary endpoints were efficacy against liver injury, function, and fibrosis.</p> <p>One adverse event (dysphonia) was observed in cohort A and one (fever) in cohort B, both of which were mild drug-related adverse events. S-005151 was well-tolerated. Regarding efficacy, there was a trend toward improvement post-treatment, with a decrease in transaminase and improvement in tissue inflammation scores in some cases; however, there was no significant improvement in hepatic dysfunction. Regarding liver fibrosis, there was a rapid and stable decrease in serum type IV collagen 7S levels, improvement in MR elastography findings, and an increase in platelet counts in some cases; 5 of 10 patients showed a trend toward improvement in liver fibrosis.</p> Conclusions <p>S-005151 is well-tolerated in patients with chronic liver disease and may have therapeutic effects, in reducing liver damage and improving liver fibrosis.</p> Trial registration <p>jRCT, jRCT 2031200232, Registered 4 December 2020 (<a href="https://jrct.mhlw.go.jp/latest-detail/jRCT2031200232">https://jrct.mhlw.go.jp/latest-detail/jRCT2031200232</a>).</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Safety and efficacy profile of S-005151 (Redasemtide), in patients with chronic liver diseases: phase 2 trial

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年5月9日

查看全文
  • Atsunori Tsuchiya,
  • Yusuke Watanabe,
  • Naruhiro Kimura,
  • Hiroyuki Abe,
  • Toru Setsu,
  • Takeshi Yokoo,
  • Hiroteru Kamimura,
  • Akira Sakamaki,
  • Hiroaki Saito,
  • Masaki Tominaga,
  • Tatsuhiko Sato,
  • Nobutaka Kitamura,
  • Takahiro Tanaka,
  • Yoshitomi Kanemitsu,
  • Masahiro Ishizawa,
  • Haruna Miyazawa,
  • Mototsugu Tanaka,
  • Hiroyuki Ishikawa,
  • Kenichi Harada,
  • Yoshihiko Tomita,
  • Katsuto Tamai,
  • Shuji Terai

摘要

Background and aims

Cirrhosis is a disease of impaired liver function and fibrosis caused by long-term liver damage. However, to date, no drugs have been approved to improve liver fibrosis. We report the results of a phase 2 study of S-005151 (generic name: Redasemtide), a partial peptide of High-Mobility Group Box 1 (HMGB1), in patients with chronic liver disease.

Approach and results

This single-center, non-randomized, single-arm, open-label study was performed in Japan in patients with chronic liver disease (cohort A: 5 patients, cohort B: 5 patients) caused by HCV, HBV, MASH, or alcohol, with MR elastography of ≥ 4 kPa and Child–Pugh score up to 7 points. The primary endpoint was safety; secondary endpoints were efficacy against liver injury, function, and fibrosis.

One adverse event (dysphonia) was observed in cohort A and one (fever) in cohort B, both of which were mild drug-related adverse events. S-005151 was well-tolerated. Regarding efficacy, there was a trend toward improvement post-treatment, with a decrease in transaminase and improvement in tissue inflammation scores in some cases; however, there was no significant improvement in hepatic dysfunction. Regarding liver fibrosis, there was a rapid and stable decrease in serum type IV collagen 7S levels, improvement in MR elastography findings, and an increase in platelet counts in some cases; 5 of 10 patients showed a trend toward improvement in liver fibrosis.

Conclusions

S-005151 is well-tolerated in patients with chronic liver disease and may have therapeutic effects, in reducing liver damage and improving liver fibrosis.

Trial registration

jRCT, jRCT 2031200232, Registered 4 December 2020 (https://jrct.mhlw.go.jp/latest-detail/jRCT2031200232).