RedHill Biopharma宣布啟動RHB-105 (TALICIA™)幽門螺桿菌感染驗證性三期試驗

RedHill Biopharma Ltd. (納斯達克：RDHL) (特拉維夫股票交易所：RDHL) (“RedHill”或“公司”) 是一家專業生物製藥公司，主要專注於開發並銷售胃腸疾病和炎症性疾病及癌症治療方面的處於後期臨床試驗階段的專有口服小分子藥物。本公司今天宣布RHB-105（新商標名稱TALICIA™）啟動治療幽門螺桿菌感染的炎症性三期試驗（根除幽門螺桿菌試驗2）。

TALICIA™ (RHB-105)是由兩種抗生素和一種質子泵抑製劑混合而成的專有固定劑量口服一體化膠囊，用於根除幽門螺桿菌感染。

驗證性三期試驗預計將完成RHB-105（新商標名稱TALICIA™）在美國提交新藥申請所需的條件，但仍取決於取得成功結果以及監管機構進一步的反饋。

本次雙臂隨機雙盲活性藥物對照組驗證性三期試驗將在美國65個臨床基地展開，計劃招募444名未接受研究、確診幽門螺桿菌的消化不良患者，主要終點是在發起治療後42天到70天期間根除幽門螺桿菌感染。

TALICIA™ (RHB-105)首個三期試驗（根除幽門螺桿菌試驗）顯示幽門螺桿菌感染根治率達到89.4%（p<0.001），證明相比目前的標準治療藥物TALICIA™ (RHB-105)在療效上具有潛在優勢。

TALICIA™ (RHB-105)獲得了美國食品藥品監督管理局根據抗生素研發激勵法案授予的合格感染疾病產品資格，享受開速通道開發，新藥申請優先審核，以及美國市場獨占權延長至8年等優惠。

幽門螺桿菌感染是慢性胃炎、消化性潰瘍、胃癌和黏膜相關的淋巴組織淋巴瘤的主要原因。據估測，全球一半以上的成人都伴有幽門螺桿菌感染。

世界衛生組織近期發布了全球12種威脅生命的抗多種藥物高優先級細菌列表，其中幽門螺桿菌感染被列入第二組高優先級細菌，亟需新的治療藥物。

按照目前的原研藥價格水平，2015年全球和美國幽門螺桿菌根治藥物潛在市場規模分別約48.3億美元和14.5億美元。

RedHill Biopharma Ltd介紹：

RedHill Biopharma Ltd (納斯達克：RDHL) (特拉維夫股票交易所：RDHL)是一家總部位於以色列的專業生物醫藥公司，主要專注於開發並銷售治療腸胃疾病和炎症性疾病以及癌症方面的處於後期臨床試驗階段的專有口服小分子藥。 RedHill在美國推廣兩款胃腸產品——治療腸易激綜合徵和急性小腸結腸炎的口服處方輔助藥物Donnatal®，以及用於醫生監督下慢性腹瀉和稀便飲食管理的醫療食品EnteraGam®。 RedHill目前處於臨床階段的產品管線包括： (i) TALICIATM (RHB-105) -治療幽門螺桿菌感染的口服混合藥，首個三期試驗獲得成功，正在進行驗證性三期試驗；(ii) RHB -104 -治療克羅恩病的口服混合藥，正在進行首項三期試驗，已經完成治療多發性硬化症的IIa期試驗並獲得非結核性分枝桿菌感染的合格感染疾病產品資格；(iii )BEKINDA@ (RHB-102) -日服一次的昂丹司瓊口服藥片製劑，急性腸胃炎和胃炎三期試驗取得成功結果，正在進行治療腹瀉型腸易激綜合徵的二期試驗；(iv ) RHB-106 -腸道準備藥物膠囊，已經授權給Salix Pharmaceuticals Ltd.；(v) YELIVA@ (ABC294640) -二期階段的口服SK2選擇性抑製劑，是首創新藥，靶向為多種腫瘤、炎症性和胃腸道適應症； (vi) MESUPRON -處於二期試驗階段的口服蛋白酶抑製劑，是首創新藥，靶向為胃腸和其他實體瘤；(vii) RIZAPORT@ (RHB-103) -利扎曲坦口服薄膜製劑，治療急性偏頭痛，正在與美國食品藥品監督管理局討論新藥申請，通過歐洲分散審批程序在兩個歐盟國家獲得上市許可。欲了解與本公司有關的更多資訊，請訪問：www.redhillbio.com。

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects, ” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation , risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate develop ment efforts; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; (iii) the extent and number of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates; (v) the Company’s ability to successfully market Donnatal ® and EnteraGam®, (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the US that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and o f the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; and (xii) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xiii) competitive companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Ex change Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 23, 2017. All forward-looking statements included in this Press Release are made only as of the date of this Press Release. We assume no obligation to update any written or oral forward-looking statement unless required by law.

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