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GNI Group Ltd.宣布F351 II期研究作為中國HBV相關肝纖維化療法的 [复制链接]

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发表于 2020-8-18 15:59 |只看该作者 |倒序浏览 |打印
GNI Group Ltd. Announces Positive Results From the Phase II Study of F351 as Therapy for HBV-related Liver Fibrosis in China

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Posted: Monday, August 17, 2020 4:50 am

Associated Press |

TOKYO--(BUSINESS WIRE)--Aug 17, 2020--

GNI Group Ltd. (GNI Group; TSE Mothers 2160), a commercial-stage biopharmaceutical company, today announced positive results from the initial analysis of Phase II clinical trial of the F351 drug candidate for liver fibrosis. The trial was a randomized, double-blind, placebo-controlled, multi-center, dose escalation study assessing the safety and efficacy of F351 for Hepatic Fibrosis in Chronic Viral Hepatitis B patients in China.

The Phase II study randomized 168 patients into 4 dose-escalating groups (placebo; 60 mg/tid; 90 mg/tid; and 120 mg/tid) with a primary endpoint of the reduction of the liver fibrosis score (Ishak Scoring System) by one grade before and after the F351 treatment, based on pathology analysis from liver biopsies. The secondary endpoints included the reduction of titers of HBV DNA, reduction of liver Fibroscan kpa score, reduction of liver inflammation score, and improvement of ALT level. The study met its primary endpoint of a statistically significant improvement in the liver fibrosis score over the 52-week treatment versus placebo (p=0.025). The 90 mg/tid (270 mg/day) group showed the best Ishak score improvement.

F351 was generally well tolerated in this study. In patients treated with placebos, 60 mg/tid F351, 90 mg/tid F351, and 120 mg/tid F351, respectively, rates of adverse events of special interest (AESIs) were as follows: rates of skin events were 11.63%, 4.76%, 7.14%, and 7.32%; rates of gastrointestinal events were 23.26%, 21.43%, 16.67%, and 19.51%; and rates of serious adverse events (SAEs) were 4.65%, 2.38%, 2.38%, and 7.32%.

“I am thrilled by the initial results of the Phase II study, which underscores the potential for F351 to benefit millions of liver fibrosis patients worldwide,” said Dr. Ying Luo, President of GNI Group. “These findings are very exciting given the same underlying molecular mechanisms for fibrosis in various types of organs and the lack of an approved drug for liver fibrosis specifically.”

More detailed results and the final report of the Phase II study will be published later at medical conferences and/or medical journals in the future. In China, F351 was granted a Major Innovative Drug status, which provides GNI Group a fast track for regulatory review and potentially faster approval. GNI Group intends to announce the strategic direction for F351 in late September or early October for the China market, as well as further steps for the U.S. and Japanese markets.

About F351 (Generic name: Hydronidone)

F351 is a New Chemical Entity (NCE) derivation of Etuary ®, which inhibits hepatic stellate cell proliferation and TGF-β signaling pathway, both of which play major roles in the fibrosis of internal organs. GNI Group has key global patent rights for F351 in a number of countries and regions including China, Japan, Australia, Canada, the United States and Europe.

GNI Group Ltd. does not expect the aforementioned matter will impact financial results for the year ending December 31, 2020.

About GNI Group Ltd.

GNI Group Ltd. is a multinational pharmaceutical company listed on the Tokyo Stock Exchange Mothers Market, Code 2160. The Group is headquartered in Tokyo, with primary business units of pharmaceuticals and medical devices with subsidiaries in Hong Kong, Shanghai, Beijing and the United States. For further information about GNI Group Ltd., please visit www.gnipharma.com.

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发表于 2020-8-18 15:59 |只看该作者
GNI Group Ltd.宣布F351 II期研究作為中國HBV相關肝纖維化療法的積極結果

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發表於:2020年8月17日,星期一4:50

美聯社|

東京-(美國商業資訊)-2020年8月17日-

商業階段的生物製藥公司GNI Group Ltd.(GNI Group; TSE Mothers 2160)今天宣布了對F351候選藥物治療肝纖維化的II期臨床試驗的初步分析得出的積極結果。該試驗是一項隨機,雙盲,安慰劑對照,多中心,劑量遞增的研究,評估了F351在中國慢性乙型肝炎患者中肝纖維化的安全性和有效性。

II期研究將168例患者隨機分為4個劑量遞增組(安慰劑; 60 mg / tid; 90 mg / tid; 120 mg / tid),主要終點是通過下列方法降低肝纖維化評分(Ishak評分系統)根據肝臟活檢的病理分析,F351治療前後為一年級。次要終點包括降低HBV DNA滴度,降低肝臟Fibroscan kpa評分,降低肝臟炎症評分和改善ALT水平。該研究達到了其主要終點,即與安慰劑相比,在52週的治療中肝纖維化評分有統計學上的顯著改善(p = 0.025)。 90 mg / tid(270 mg / day)組顯示出最佳的Ishak評分改善。

在這項研究中,F351一般耐受良好。在分別接受60 mg / tid F351、90 mg / tid F351和120 mg / tid F351的安慰劑治療的患者中,特殊關注的不良事件(AESIs)發生率如下:皮膚事件發生率分別為11.63%,4.76 %,7.14%和7.32%;胃腸道事件發生率分別為23.26%,21.43%,16.67%和19.51%;嚴重不良事件(SAE)的發生率分別為4.65%,2.38%,2.38%和7.32%。

GNI集團總裁羅穎博士說:“ II期研究的初步結果令我感到興奮,這突顯了F351可能使全球數百萬肝纖維化患者受益。” “鑑於各種類型的器官中纖維化的基本分子機制相同,並且缺少專門用於肝纖維化的藥物,這些發現令人非常激動。”

更詳細的結果和II期研究的最終報告將在以後的醫學會議和/或醫學期刊上發表。在中國,F351被授予重大創新藥物資格,這為GNI集團提供了進行法規審查和快速批准的快速途徑。 GNI集團打算在9月下旬或10月初宣布針對中國市場的F351戰略方向,以及針對美國和日本市場的進一步措施。

關於F351(通用名稱:對苯二酚)

F351是Etuary®的新化學實體(NCE)衍生物,它抑制肝星狀細胞增殖和TGF-β信號通路,這兩者在內部器官纖維化中起主要作用。 GNI集團在包括中國,日本,澳大利亞,加拿大,美國和歐洲在內的許多國家和地區擁有F351的關鍵全球專利權。

GNI Group Ltd.預計上述事項不會影響到2020年12月31日止年度的財務業績。

關於GNI集團有限公司

GNI Group Ltd.是一家在東京證券交易所母親市場(代碼2160)上市的跨國製藥公司。該集團總部位於東京,其主要業務部門是藥品和醫療器械,並在香港,上海,北京和美國設有子公司。 。有關GNI Group Ltd.的更多信息,請訪問www.gnipharma.com

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