NASDAQ OMX

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

Dela
  • 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



Följ NASDAQ OMX

Abonnera på våra pressmeddelanden.

Senaste pressmeddelandena från NASDAQ OMX

JDS Development Group Secures $137 Million Construction Financing From Madison Realty Capital for Distinctive Miami Beach Condominium Monad Terrace25.4.2018 00:43Pressmeddelande

New York-based Madison Realty Capital Provides Final Funding for Pritzker Prize-Winner Jean Nouvel's First Built Work in Miami MIAMI , April 24, 2018 (GLOBE NEWSWIRE) -- New York-based Madison Realty Capital has provided a $137 million construction loan to New York-based JDS Development Group for Monad Terrace. The deal indicates conviction in the development team, the high-design product by Pritzker Prize-winning architect Jean Nouvel and the South Beach market's extremely limited new development inventory and viability. The financing will fully capitalize the project, which features 59 individually-designed waterfront residences. "This is a unique assemblage of land within a prime waterfront residential enclave in South Beach, Miami and we are excited to close another transaction with an esteemed developer like Michael Stern," said Josh Zegen, Co-Founder and Managing Principal of MRC. "In addition, there's virtually no new development product coming out of the ground in South Beach r

Williams Scotsman to Announce First Quarter 2018 Results on May 3, 201824.4.2018 21:59Pressmeddelande

BALTIMORE, April 24, 2018 (GLOBE NEWSWIRE) -- WillScot Corporation (NASDAQ:WSC) ("Williams Scotsman") today announced that it will release its first quarter 2018 financial results on Thursday, May 3, 2018, after the markets close. President and Chief Executive Officer Bradley Soultz, and Chief Financial Officer Timothy Boswell will host a conference call and webcast on Friday, May 4, 2018, at 10:00 a.m. EDT to discuss the results for the first quarter. The live call can be accessed by dialing (855) 312-9420 (U.S./Canada toll-free) or (210) 874-7774 (international). A live webcast will also be accessible via the "Events & Presentations" section of the Company's Investor Relations website https://investors.willscot.com. An archived version of the webcast will be available for 60 days following the call. About WillScot Corporation Headquartered in Baltimore, Maryland, WillScot Corporation is the public holding company for the Williams Scotsman family of companies in the United States, Can

Nasdaq Announces Results from 2018 Annual Meeting of Stockholders24.4.2018 20:00Pressmeddelande

Jacob Wallenberg, New Director, Elected to the Board and Nine Directors Re-elected Nasdaq Board Re-elects Michael R. Splinter as Chairman of the Board NEW YORK, April 24, 2018 (GLOBE NEWSWIRE) -- Nasdaq, Inc. (Nasdaq:NDAQ) stockholders today elected all nominated directors at the company's Annual Meeting of Stockholders. All directors will serve one-year terms. Elected board members include: Melissa M. Arnoldi, President of Technology & Operations, AT&T Communications Charlene T. Begley, Retired SVP & CIO, General Electric Company Steven D. Black, Co-CEO, Bregal Investments Adena T. Friedman, President and CEO, Nasdaq Essa Kazim, Governor, Dubai International Financial Center and Chairman, Borse Dubai and Dubai Financial Market Thomas A. Kloet, Retired CEO & Executive Director, TMX Group Limited John D. Rainey, CFO and EVP of Global Customer Operations, PayPal Holdings, Inc. Michael R. Splinter, Retired Chairman and CEO, Applied Materials, Inc. Jacob Wallenberg, Chairman, Investor AB L

Inspiration Updates Proposed Acquisition of Compassion Cannabis24.4.2018 17:00Pressmeddelande

TORONTO, April 24, 2018 (GLOBE NEWSWIRE) -- Inspiration Mining Corporation (CSE:ISM) (the "Corporation") is pleased to announce that its ongoing negotiations with Compassion Cannabis Corp ("Compassion") and the related due diligence is going very well and ahead of the targeted date. The Corporation has commenced discussions pertaining to the terms and conditions of a proposed share exchange agreement and the resulting structure of the Corporation's board of directors. Compassion is a private Ontario company which has expertise to forward various facets of the explosive new market of the marijuana industry, including but not limited to the "Vape" market and dispensary centers for the industry. The Corporation believes that this is an extremely lucrative space with tremendous demand in the medical cannabis industry. The cannabis market is growing exponentially every day with new and exciting innovations in the industry. Compassion has narrowed down its possible research and development l

Barings Supports Liberty Hall on Refinancing of AIM Aerospace24.4.2018 16:00Pressmeddelande

CHARLOTTE, N.C., April 24, 2018 (GLOBE NEWSWIRE) -- Barings, one of the world's leading financial services firms, announced today that it served as the sole agent and lead arranger on first lien senior credit facilities to support Liberty Hall Capital Partners' refinancing of the existing debt of its portfolio company, AIM Aerospace. AIM Aerospace, based in Renton, Washington, is a leading designer and producer of advanced composite structures, systems, engine components and thermoplastic technology for the global aerospace industry. The company supplies thermoset and thermoplastic composite solutions to Tier 1 aero-structure and aero-equipment suppliers and to aircraft original equipment manufacturers (OEMs). "Liberty Hall appreciates the partner-like approach that Barings brought to support our investment in AIM Aerospace," said Rowan Taylor, Liberty Hall's founding Partner. "Barings' creativity in structuring, ability to move quickly and speak for the entire facility helped expedite

Appian Announces Strategic Technology Alliance with Genesys24.4.2018 15:04Pressmeddelande

Companies align development, marketing, and sales to deliver intelligent case management for contact center excellence RESTON, Va., April 24, 2018 (GLOBE NEWSWIRE) -- Appian (NASDAQ:APPN) today announced a strategic technology alliance with Genesys®, the global leader in omnichannel customer experience and contact center solutions. The partnership will benefit organizations seeking next-generation customer engagement solutions that integrate the case management, intelligent automation, and low-code application development capabilities of Appian with the Genesys Customer Experience Platform. "Over the last several years, Serco has used Appian technology, alongside Genesys, to deliver contact solutions to its Federal customers, having processed tens of millions of cases across thousands of contact center agents through our systems. We are excited to hear about the tighter technology partnership between Appian and Genesys as it opens up the possibility to deliver more efficient solutions

I vårt pressrum kan du läsa de senaste pressmeddelandena, få tillgång till pressmaterial och hitta kontaktinformation.

Besök vårt pressrum