NASDAQ OMX

RedHill Biopharma Announces Enrollment of Last Patient in the BEKINDA® Phase II Study for IBS-D

24.4.2017 13:00 | NASDAQ OMX

Del
  • Top-line results are expected in the third quarter of 2017 
     
  • The randomized, double-blind, placebo-controlled Phase II study is evaluating the safety and efficacy of BEKINDA® (RHB-102) 12 mg in 127 U.S. patients with diarrhea-predominant irritable bowel syndrome (IBS-D)
     
  • IBS is one of the most common gastrointestinal disorders; it is estimated that at least 30 million Americans suffer from IBS, of which over 40% are cases of IBS-D
     
  • If approved, BEKINDA® 12 mg has the potential to be a preferred once-daily treatment for a broad segment of patients suffering from IBS-Dtargeting a U.S. potential market estimated to exceed $1 billion by  2022
     
  • Top-line results from a Phase III study with BEKINDA® 24 mg for acute gastroenteritis and gastritis (the GUARD study) are expected in the second quarter of 2017
     
  • RedHill will host an R&D Day and live webcast on BEKINDA® on Thursday, April 27, 2017 in NYC, discussing the product, indications, potential markets and the ongoing Phase III and II studies for acute gastroenteritis and IBS-D, respectively

TEL-AVIV, Israel, April 24, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced enrollment of the last patient in the Phase II study with BEKINDA® (RHB-102)1 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).

BEKINDA® is a proprietary, bimodal extended-release, once-daily oral pill formulation of ondansetron, targeting several gastrointestinal indications.

The randomized, double-blind, placebo-controlled Phase II study is evaluating the safety and efficacy of BEKINDA® 12 mg in adults over the age of 18 with IBS-D. The study enrolled 127 subjects in 16 U.S. clinical sites. Top-line results are expected in the third quarter of 2017.

Subjects enrolled in the Phase II IBS-D study were randomized 60:40 to receive either BEKINDA® 12 mg or a placebo, once daily, for a period of eight weeks. The primary endpoint for the study is the proportion of patients in each treatment group with response in stool consistency as compared to baseline, per FDA guidance definition. Secondary endpoints include the proportion of patients in each treatment group who are pain responders and the proportion of patients in each treatment group who are responders to the combined endpoints of stool consistency and pain, per FDA guidance definition.

IBS is one of the most common gastrointestinal disorders2. It is estimated that at least 30 million Americans suffer from IBS3, of which over 40% are cases of IBS-D4. The U.S. potential market for IBS-D treatments is estimated to exceed $1 billion by 20225.

5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in BEKINDA®, have been shown to slow intestinal transit time in humans6. Alosetron (Lotronex®), a 5-HT3 antagonist of the same class of drugs as ondansetron, has been approved by the FDA for the treatment of women with severe chronic IBS-D, but is under a restricted prescribing (REMS) program due to potential severe side effects7. Ondansetron, approved by the FDA as an oncology support antiemetic, has demonstrated activity in IBS-D in preliminary studies8 and, in light of its safety profile, RedHill believes that BEKINDA®, if approved, has the potential to be a preferred once-daily treatment for a broad segment of patients suffering from IBS-D.

Top-line results from the Phase III study with BEKINDA® 24 mg for acute gastroenteritis and gastritis (the GUARD study) are expected in the second quarter of 2017. In February 2017, RedHill announced that the last patient had completed the treatment course and observation period in the randomized, double-blind, placebo-controlled GUARD study, which treated 320 adults and children over the age of 12 in 29 U.S. clinical sites.   

The Phase II study and the Phase III GUARD study with BEKINDA® are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health, which provides access to information on publicly and privately supported clinical studies.

About BEKINDA ®  (RHB-102):
BEKINDA® is a proprietary, bimodal extended-release (24 hours) oral pill formulation of ondansetron, covered by several issued and pending patents. A Phase III clinical study of BEKINDA® 24 mg formulation for acute gastroenteritis and gastritis (the GUARD study) is ongoing in the U.S., with patient treatment course and observation period completed and top-line results expected in the second quarter of 2017. A Phase II study with BEKINDA® 12 mg formulation is ongoing in the U.S. for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), with patient enrollment completed and top-line results expected in the third quarter of 2017.

About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) is a specialty biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill has a U.S. co-promotion agreement with Concordia for Donnatal® , a prescription oral adjunctive drug used in the treatment of IBS and acute enterocolitis, as well as an exclusive license agreement with Entera Health for EnteraGam® , a medical food intended for the dietary management, under medical supervision, of chronic diarrhea and loose stools. RedHill's clinical-stage pipeline includes: (i) RHB-105 - an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study; (ii) RHB-104 - an oral combination therapy for the treatment of Crohn's disease with an ongoing first Phase III study, a completed proof-of-concept Phase IIa study for multiple sclerosis and QIDP status for nontuberculous mycobacteria (NTM) infections; (iii) BEKINDA®  (RHB-102) - a once-daily oral pill formulation of ondansetron with an ongoing Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106 - an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640) - a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered protease inhibitor, targeting pancreatic cancer and other solid tumors and (vii) RIZAPORT® (RHB-103) - an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in two EU member states under the European Decentralized Procedure (DCP). More information about the Company is available at: 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 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 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 U.S. 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 of 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 Exchange 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.

_________________________

1 BEKINDA® is an investigational new drug, not available for commercial distribution.

2 GlobalData PharmaPoint: Irritable Bowel Syndrome - Global Drug Forecast and Market Analysis to 2023.

3 Lovell RM, Ford AC, Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis, Clin Gastroenterol Hepatol (2012), 10(7)712-721; Saito YA et al, The epidemiology of irritable bowel syndrome in North America: a systemic review, Am J Gastroenterol (2002), 97(8): 1910-5.

4 GlobalData PharmaPoint: Irritable Bowel Syndrome - Global Drug Forecast and Market Analysis to 2023.

5 EvaluatePharma - Irritable bowel syndrome Indication Profile.           

6 Garsed K. et al, A randomised trial of ondansetron for the treatment of irritable bowel syndrome with diarrhoea, Gut (2014), 63(10): 1617-25.  

7 www.fda.gov, post market drug safety information for patients and providers.

8 Steadman CJ et al, Selective 5-hydroxytryptamine type 3 receptor antagonism with ondansetron as treatment for diarrhea-predominant irritable bowel syndrome: a pilot study, Mayo Clin Proc (1992), 67(8):732-8; Clayton NM et al, The pharmacological properties of the novel selective 5-HT3 receptor antagonist, alosetron, and its effects on normal and perturbed small intestinal transit in the fasted rat, Neurogastroenterol (1999), 11: 207-217; Garsed K. et al, A randomised trial of ondansetron for the treatment of irritable bowel syndrome with diarrhoea, Gut (2014), 63(10): 1617-25.

Company contact:
Adi Frish
Senior VP Business Development & 
Licensing 
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com

IR contact (U.S.): 
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com



This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: RedHill Biopharma Ltd. via Globenewswire

Om NASDAQ OMX

NASDAQ OMX
NASDAQ OMX
One Liberty Plaza - 165 Broadway
NY 10006 New York

+1 212 401 8700http://www.nasdaqomx.com

NASDAQ OMX (NASDAQ: NDAQ) is a leading provider of trading, exchange technology, information and public company services across six continents.

Følg saker fra NASDAQ OMX

Registrer deg med din epostadresse under for å få de nyeste sakene fra NASDAQ OMX på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra NASDAQ OMX

Constellation Brands to Present at Barclays Global Consumer Staples Conference, September 6, 201722.8.2017 15:04Pressemelding

VICTOR, N.Y., Aug. 22, 2017 (GLOBE NEWSWIRE) -- Constellation Brands, Inc. (NYSE:STZ) (NYSE:STZ.B), a leading beverage alcohol company, announced today that David Klein, chief financial officer and Bill Newlands, chief operating officer, will present at the Barclays Global Consumer Staples Conference on Wednesday, September 6, 2017, at the Intercontinental Hotel in Boston, MA. The presentation is scheduled to begin at 11:15 a.m. EDT and is expected to cover the company's strategic business activities, financial and operational performance, and outlook for the future.             A live audio webcast of the presentation can be accessed on the company's website at www.cbrands.com by following the instructions in the "Investors" section. Following the presentation, the webcast will be available on the company's website for replay through the close of business on Friday, October 27, 2017. Financial and statistical information discussed in the presentation and a reconciliat

Patton Among Top Ten 2017 UC Solutions Providers22.8.2017 14:00Pressemelding

Patton offers a unique set of competencies and capabilities that help companies bring their UC dreams into reality GAITHERSBURG, Md., Aug. 22, 2017 (GLOBE NEWSWIRE) -- Patton Electronics-US manufacturer of UC, cloud, and IoT enabling solutions for carrier, enterprise and industrial networks-has been named among the top ten unified communications (UC) solutions providers according to InsightsSuccessmagazine. Patton is doing some unusual things that no other network equipment manufacturer does to enable UC implementations. Patton offers a unique set of competencies and capabilities that help companies bring their UC dreams into reality. Two examples... SmartNode enterprise session border controllers (eSBC) address a broad range of networking functions including IP security, legacy telephony integration (analog and ISDN), network demarcation, and much more-all in a single customer

Manuport Logistics Uses Descartes for SOLAS Compliance22.8.2017 12:45Pressemelding

LIER, Belgium, Aug. 22, 2017 (GLOBE NEWSWIRE) -- Descartes Systems Group (Nasdaq:DSGX) (TSX:DSG), the global leader in uniting logistics-intensive businesses in commerce, announced that Manuport Logistics in Belgium is using the Descartes Verified Gross Mass(TM) (Descartes VGM(TM)) solution to help its customers comply with the International Convention for the Safety of Life at Sea (SOLAS) regulations for container weight requirements. "The long-standing relationship Manuport has with Descartes played an important role in our selection of the Descartes VGM solution; however, it was the rapid implementation capabilities that really differentiated Descartes," said Luc Geerts, Strategic Accounts Manager at Manuport Logistics. "In addition, Descartes has an impressive track record in networked communication and the Descartes VGM solution uses a similar Descartes standard message format as we do for managing shipments. In the maritime industry where messaging standards

Blackbird Energy Inc. Announces the Appointment of Allan Dixon as Business Development Manager22.8.2017 09:00Pressemelding

CALGARY, Alberta, Aug. 22, 2017 (GLOBE NEWSWIRE) -- Blackbird Energy Inc. (TSX-V:BBI) ("Blackbird") is pleased to announce the appointment of Allan Dixon as Business Development Manager.  In this role Mr. Dixon will be responsible for investor relations, communication initiatives and strategic business awareness programs in North America and Europe. Mr. Dixon has an expansive background in Calgary's oil and gas industry including experience in investor relations at Birchcliff Energy Ltd., equity research at National Bank Financial and investment banking at Tristone Capital. Mr. Dixon holds a B.Comm. degree with a specialization in finance from Dalhousie University. "I am very pleased to welcome Allan to the Blackbird team and look forward to working with him. His diverse background and experience working with some of the top thought leaders in the industry gives me great confidence he will be a valuable addition to our team and an asset for all

ZIM Adds MatchBack Systems Analytics Services in Italy21.8.2017 22:00Pressemelding

Innovative approach to gain efficiencies through fewer empty container moves adds significant value for ZIM's customers GREEN BAY, Wis. and ROTTERDAM, The Netherlands, Aug. 21, 2017 (GLOBE NEWSWIRE) -- MatchBack Systems, Inc. ( www.matchbacksystems.com ), the leading software as a service (SaaS) solution to plan, optimize and automate matchbacks, announced that ZIM Integrated Shipping Ltd. joined the company's customer base on May 1, 2017 to optimize their inland operation in Italy. The account will be serviced through the European office in Rotterdam and corporate headquarters in North America. The system will be deployed for a 2 months pilot after which the parties will evaluate the scope for a broader cooperation. A photo accompanying this announcement is available at  http://www.globenewswire.com/NewsRoom/AttachmentNg/1cb9a632-22a4-4ff5-a3d5-d8b3964e5113 Gil Lehmann, Head of Global Land Tra

Promethean Opens New Global Headquarters in Seattle18.8.2017 18:38Pressemelding

Seattle, Wash., Aug. 18, 2017 (GLOBE NEWSWIRE) -- PrometheanTM, a global education technology company, announced today the opening of its new global headquarters in Seattle, Wash. Promethean's office in Atlanta, Ga. will continue to serve as the hub for the Americas markets, and the Blackburn, U.K. office will continue to carry on as the hub for the EMEA markets and parts of Asia.  Promethean is one of the leading brands in the international education technology market with more than 20 years of experience in the K-12 classroom. Its solutions are in more than 50,000 schools and institutions in 154 countries. "As traditional pedagogy continues to move towards immersive learning, it's important for Promethean to lead innovation in education with the latest technology," said Vin Riera, CEO of Promethean. "Seattle is a global technology hub, and establishing Promethean's global headquarters there increases opportunities for new business models, concepts

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom