Hepatitis B new drug CMX157 is undergoing multiple incremental dose assessment in Phase 2a clinical studies
October 17, 2016 Source: Drug Information Network
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)]; Co ntraVir Pharmaceuticals , a biopharmaceutical company focused on antiviral treatment development and marketization, announced positive mid-term data on its new anti-hepatitis B virus (HBV) drug CMX157, a potent tenofovir prodrug molecule currently Multiple incremental dose assessments are being conducted in Phase 2a clinical studies.
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In March 2015, the World Health Organization released the first guideline for the prevention, care and treatment of chronic hepatitis B infection: it recommended the use of nucleotide analogue oral drugs – tenofovir or entecavir – as first- and second-line drugs. This is a class of effective drugs that inhibit the HBV virus, resulting in less drug resistance, one tablet per day, with few side effects.
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ContraVir, a biopharmaceutical company, is particularly focused on developing potentially innovative therapies for the HBV virus. The company's new anti-HBV compound, CMX157, is a highly potent analog of the successful antiviral drug tenofovir and is currently in Phase 2a clinical trials in patients with HBV . CMX157's novel liver-targeted molecular structure can achieve low levels of tenofovir in vivo circulation, reducing systemic exposure and thereby reducing renal side effects.
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CMX157 previously completed a phase-dose clinical trial of phase 1b in healthy volunteers, in which participants were treated with up to 100 mg daily for up to 14 days, showing excellent safety, tolerability, and drug distribution profiles. . Based on the potential of the CMX157 best-in-class, ContraVir believes that CMX157 can be a cornerstone in the treatment of hepatitis B.
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A total of 60 patients with newly diagnosed chronic HBV infection were enrolled in the Phase 2a multi-incremental dose clinical trial, and CMX157 was compared with existing standard treatment regimens. The sequential dose escalation model was designed for 10 patients in each group and received a daily dose of 5, 10, 25, 50, and 100 mg for four weeks, plus two patients in each group receiving a standard treatment regimen of 300 mg.
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At present, the group trials of 5 mg and 10 mg have been successfully completed. The published interim data are from 10 HBV-infected patients, once a day for 14 days, 25 mg CMX157 orally, and the other two HBV patients are also given 300 mg standard treatment regimen. Up to 14 days. Patients treated with CMX157 had an average reduction in HBV viral load of up to 99% compared to baseline levels. Importantly, the antiviral activity of CMX157 is comparable to the antiviral activity of standard treatment regimens, but at a dose of only 1/12.
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A key goal of this study was to monitor the level of active tenofovir in the blood, which is one of the key factors leading to off-target side effects. After oral administration, the levels of CMX157 and active tenofovir in the blood were roughly proportional to the dose in chronic HBV patients and previous healthy volunteer studies. It is worth noting that CMX157 does not appear to break down into active tenofovir in the blood compared to patients taking standard treatment regimens. CMX157 is expected to achieve similar antiviral activity while significantly reducing systemic tenofovir exposure in vivo.
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Mr. James Sapirstein, CEO of ContraVir, said: "We are happy and excited about these clinical results because they demonstrate that CMX157 has great potential for effective treatment of HBV infection. Low doses of CMX157 can effectively reduce viral load, plus good safety. The drug's unique liver targeting mechanism was validated: the antiviral activity of tenofovir is concentrated in the liver, achieving anti-HBV benefits at lower doses and minimal drug exposure. Based on these outstanding data, we consider CMX157 Has great potential as a safe and efficient cornerstone component in a combination therapy for HBV infection."
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