Spring Bank Hepatitis B Drug Enhances Antiviral Effect in HBeAg Negative Patients
March 15, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];On March 14, the US Spring Bank Pharmaceutical Company announced that the company's chief medical officer, Nezam Afdhal, will give an oral report at the 2018 Asia Pacific Association for Liver Research (APASL) annual meeting to introduce the ongoing phase 2 clinical trial "ACHIEVE" Part A. Comprehensive study results of the 25 mg and 50 mg cohorts. The study evaluated the treatment of chronic hepatitis B virus (HBV) with the drug inarigivir soproxil. The inarigivir under development is an oral selective immunomodulator that can be used as a potential component of hepatitis B combination therapy. The company's development goal is to significantly improve the functional cure rate of hepatitis B in a simple, safe and selective manner. Tenofovir disoproxil fumarate (sold by Gilead, trade name Viread) was administered 300 mg daily for 12 weeks in all patients in the two low-dose groups.
The data of the first two groups of inarigivir monotherapy for 12 weeks and 24 weeks showed that the viral markers HBV DNA, HBV RNA and HBsAg were significantly reduced, with good safety and tolerance.
Data published on APASL included data from 30 patients receiving inarigivir and 8 placebo patients in a previous low-dose group. Inarigivir single-agent potent antiviral response (defined as HBV DNA reduction >1 log10, HBV RNA reduction >3 log10 (or undetectable) was observed in 8 patients. In addition, anti-observation was observed in patients with low viral load at baseline Increased viral effects (standards HBsAg<104 and HBV DNA<106). There was a dose-dependent relationship between PK and antiviral effects in these initial low-dose inarigivir-treated patients. In addition, fumaric acid was switched to 12 weeks. Dinofovir 300 mg is associated with a significant reduction in HBV DNA levels, but as expected, has little effect on further reduction of HBV RNA, suggesting that inarigivir acts as a direct antiviral drug that blocks HBV RNA encapsidation and acts as an immune Modulators have an important dual mechanism of action in stimulating immune-mediated clearance of ccccDNA.
Afdhal, the company's chief medical officer, said: "When examining 11 HBeAg-negative patients who received inarigivir 25 mg or 50 mg monotherapy, we found a higher response rate than HBeAg-positive patients, at the end of the 12-week treatment period, In 55% of patients, HBV DNA decreased by >1 log 10, while HBV RNA decreased by >3 log 10. In addition, 9 of 30 patients appeared at week 12 or 24 after transition to tenofovir fumarate. The decrease in HBsAg of 0.5 log10 again highlights the potential of inarigivir as a fundamental treatment for the healing of hepatitis B virus function."
Spring Bank also announced that the company will soon end the first 12 weeks of treatment for the second group (100 mg) of monotherapy in Phase A of the Phase 2 clinical trial of ACHIEVE. After review and approval by the Data Security Monitoring Committee, Spring Bank expects to begin recruiting a fourth batch (200 mg) of patients in the first half of 2018.
As previously reported, Spring Bank has partnered with Gilead in clinical trials, under which Gilead is funding and conducting a Phase 2 clinical trial to evaluate inarigivir and tenofovir alafenamide (Geely De sales, trade name vemlidy) in combination with the treatment of hepatitis B patients. Similar to the experimental protocol of Part A of the ACHIEVE trial, the collaborative phase 2 trial involved a 12-week combination of inarigivir (50 mg) and Vemlidy. After treatment, all patients will receive a single-treatment of Vemlidy for 36 weeks. Gilead has recently started the inarigivir 50mg+Vemlidy cohort study in this clinical trial, and the results of this study are expected to be published in the second half of 2018. (Sina Pharmaceutical Compilation / David)
Article References: Spring Bank Announces Presentation of Combined Inarigivir 25 mg and 50 mg 12 and 24 Week ACHIEVE Results Demonstrating Enhanced Anti-Viral Efficacy in HBeAg-Negative Patients
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