RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) 是一家生物製藥公司，主要專注於開發並銷售炎症性疾病和胃腸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。該公司今日宣佈IIa期概念驗證臨床試驗當中規劃的最後一位患者的複查訪問工作已完成，該項試驗旨在評估RHB-104治療復發-緩解型多發性硬化癥（RRMS）的潛力。
此次開放性IIa期試驗共招募了18位RRMS患者，設計有一系列的探索性終點，其目的旨在評估RHB-104固定口服劑量作為干擾素β-1a輔助治療藥物的安全性和潛在療效。病人會接受RHB-104治療24周，然後會接受另外24周的評估，在此期間，病人會在不接受RHB-104輔助治療情況下接受干擾素β-1a治療。
這項研究目前正在進行中，其最終的頂線結果預計將在2016年第四季度公佈，但這取決於審核要求和臨床研究報告的完成。
RedHill Biopharma Ltd介紹：
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) 是一家總部位於以色列的新興生物醫藥公司，主要專注於開發幷銷售治療炎症性疾病和腸胃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。 公司目前的產品管線包括：(i) 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；(ii) RHB-104 -治療克羅恩病的口服混合藥，正在進行首個三期試驗以及治療多發性硬化症的二a期概念驗證試驗；(iii) BEKINDA™ (RHB-102) -日服一次的昂丹司瓊口服藥片製劑，正在美國進行治療急性腸胃炎和慢性胃炎的三期試驗，以及治療腹瀉型腸易激綜合征的二期試驗；(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選擇性抑制劑，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uPA抑制劑口服膠囊，是首創新藥，靶向為胃腸和其他實體瘤；(vii) RP101 – Hsp27抑制劑口服藥片，是處於二期試驗階段的首創新藥，靶向為胰腺癌和其他胃腸癌，RedHill擁有該藥物的收購選擇權；(viii) RIZAPORT™ (RHB-103) -利紮曲坦口服薄膜製劑，用於治療急性偏頭痛，正在與美國食品藥品監督管理局討論新藥申請，2015年10月獲准在德國上市；以及(ix) RHB-101 -心血管藥物卡維地洛日服一次的口服藥片製劑。
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 development 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 establish and maintain corporate collaborations; (vi) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (vii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and of the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) 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; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) estimates of the Company’s expenses, future revenues capital requirements and the Company’s needs for additional financing; (xii) competitive companies and technologies within the Company’s industry; and (xiii) the impact of the political and security situation in Israel on the Company’s business. 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 Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on February 25, 2016. 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.
公司連絡人：
Adi Frish
業務發展和許可高級副總裁
RedHill Biopharma
+972-54-6543-112
[email protected]
投資者關係連絡人（美國）：
Marcy Nanus
高級副總裁
The Trout Group
+1-646-378-2927
[email protected]
