DUBLIN, May 1, 2017 /PRNewswire/ -- Allergan plc (NYSE: AGN) today announced that the company and its collaborators will present clinical and preclinical data for Linzess® (linaclotide) and linaclotide delayed release, Viberzi® (eluxadoline), relamorelin CIV, and cenicriviroc at the upcoming Digestive Disease Week® (DDW) in Chicago, IL, May 6 through May 9, 2017.
At this year's meeting, researchers will present late-breaking clinical data focusing on the effect of linaclotide delayed release on abdominal pain in Irritable Bowel Syndrome with Constipation (IBS-C), as well as key presentations focusing on treatment satisfaction with Linzess® for patients with Chronic Idiopathic Constipation (CIC), comprising an indirect treatment comparison in addition to stool consistency and frequency data. Additional researchers will also present clinical data on Viberzi® for the treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D), including a patient-reported outcomes based severity index and results from a patient survey on the burden of IBS-D symptoms. Lastly, data on relamorelin for the treatment of gastroparesis and cenicriviroc for the treatment of non-alcoholic steatohepatitis (NASH) will also be presented.
The data will be presented via oral and poster presentations as follows:
Phase IIb Data on the Effect on Linaclotide Delayed Release on Abdominal Pain in IBS-C (Late-Breaker):
- Targeted delivery of linaclotide to specific areas of the intestine affects clinical efficacy in patients with irritable bowel syndrome with constipation (IBS-C) (poster presentation) (session ID 9230), by William D. Chey, University of Michigan, Division of Gastroenterology, Department of Medicine, Michigan Medicine, Ann Arbor, MI, will be presented at the Clinical Science, Late-Breaking session taking place on Tuesday, May 9, Noon to 2:00 p.m.
Treatment Satisfaction and Additional Clinical Analyses of Linzess® in CIC:
- Indirect treatment comparison: placebo-adjusted results from phase 3 trials of two GC-C agonists in patients with chronic idiopathic constipation - linaclotide and plecanatide (poster presentation) (session ID 7120) by Philip Schoenfeld, MD, University of Michigan School of Medicine, Ann Arbor, MI will be presented at the Constipation and Other Functional Colonic Syndromes session taking place on Sunday, May 7, Noon to 2:00 p.m.
- The relationship of patient-reported treatment satisfaction with stool consistency and frequency in chronic idiopathic constipation (CIC) patients treated with linaclotide or placebo (poster presentation) (session ID 7120), by Darren Brenner, MD, Northwestern University Feinberg School of Medicine, Chicago, IL, will be presented at the Constipation and Other Functional Colonic Syndromes session taking place on Sunday, May 7, Noon to 2:00 p.m.
Sustained Response and Additional Clinical Analyses of Linzess® in IBS-C:
- Intestinal, non-intestinal, and extra-digestive response to linaclotide in patients with irritable bowel syndrome with constipation: results at week 4 predict sustained response (oral presentation) (session ID 3185), by Enrique Rey, MD, Hospital Clínico San Carlos, Madrid, Spain, will be presented at the Irritable Bowel Syndrome session taking place on Sunday, May 7, 8:00 a.m. to 9:30 a.m.
Similarities and Differences in Symptoms and Quality of Life for Patients with IBS-C or CIC:
- Differences in demographic and symptom-related characteristics among patients with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC): Results from the CONTOR Study (poster presentation) (session ID 8160) by Jessica Abel, Allergan, plc, will be presented at the Patient Reported Outcomes: IBD, GERD, Functional Disorders session taking place on Monday, May 8, Noon to 2:00 p.m.
Irritable Bowel Syndrome with Diarrhea (IBS-D) (Poster Presentations):
- Towards a patient-reported outcomes based severity index of irritable bowel syndrome with diarrhea (session ID 8160) by Anton Emmanuel, University College Hospital, London, will be presented at the Patient Reported Outcomes: IBD, GERD, Functional Disorders session taking place on Monday, May 8, Noon to 2:00 p.m.
- Understanding symptom burden and attitudes in patients with irritable bowel syndrome with diarrhea: results from a patient survey (session ID 8160) by Gwen Wiseman, Allergan, Ltd, will be presented at the Patient Reported Outcomes: IBD, GERD, Functional Disorders session taking place on Monday, May 8, Noon to 2:00 p.m.
Relamorelin for the Treatment of Diabetic Gastroparesis:
- Relamorelin in patients with diabetic gastroparesis: efficacy and safety results from a Phase 2b randomized, double-blind, placebo-controlled, 12-week study (RM-131-009) (plenary session) (session ID 4325) by Michael Camilleri, Mayo Clinic, Rochester, MN, will be presented at the AGA Institute Presidential Plenary session taking place on Monday, May 8, 10:00 a.m. to 12:00 p.m.
- Development and psychometric evaluation of the diabetic gastroparesis symptom severity diary (poster session) (session ID 7125) by Sheri Fehnel, RTI Health Solutions, Research Triangle Park, will be presented at the Gastroparesis session taking place on Sunday, May 7, Noon to 2:00 p.m.
Cenicriviroc for the Treatment of Non-Alcoholic Steatohepatitis (NASH):
- Effect of acid-reducing agents omeprazole and famotidine on the pharmacokinetics of cenicriviroc in healthy subjects (poster presentation) (session ID 9090) by Star Seyedkazemi, Allergan plc, South San Francisco, CA, will be presented at the Clinical Steatohepatitis session taking place on Tuesday, May 9, Noon to 2:00 p.m.
About Linzess® (Linaclotide)
LINZESS® (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). Please see full Prescribing Information: http://www.allergan.com/assets/pdf/linzess_pi. Linzess® and linaclotide delayed release are a guanylate cyclase‐C (GC‐C) agonist. Linaclotide binds to the GC-C receptor locally, within the intestinal epithelium, and is thought to work in two ways, based on nonclinical studies. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit, as well as a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established. Linaclotide is marketed by Allergan plc and Ironwood in the United States as LINZESS® and is indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), with nearly 1.5 million unique patients in the United States having filled nearly 7 million linaclotide prescriptions since launch, according to IMS Health. In Europe, Allergan markets linaclotide under the brand name Constella® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood's partner Astellas markets linaclotide under the brand name Linzess® for the treatment of adults with IBS-C. Ironwood also has partnered with AstraZeneca for development and commercialization of linaclotide in China and with Allergan for development and commercialization of linaclotide in all other territories worldwide.
About Viberzi® (Eluxadoline)
Eluxadoline is marketed by Allergan in the United States as Viberzi® (eluxadoline) CIV. Viberzi® is a twice daily, oral medication used to treat adults with irritable bowel syndrome with diarrhea (IBS-D). Viberzi® has mixed opioid receptor modulator activity; it is a mu- and kappa-opioid receptor agonist and a delta-opioid receptor antagonist. Viberzi acts locally in the gut and is thought to decrease visceral hypersensitivity and control GI motility, based on nonclinical studies. Viberzi® is indicated for the treatment of IBS-D in adult men and women. Please also see full Prescribing Information: https://www.allergan.com/assets/pdf/viberzi_pi.
Relamorelin is a potent ghrelin agonist in development for the treatment of diabetic gastroparesis. Derived from the natural ghrelin sequence, relamorelin has been optimized to stimulate gastrointestinal (GI) motility, with greater potency and enhanced stability and pharmacokinetics. The U.S. Food and Drug Administration (FDA) has granted Fast Track review status to relamorelin for the treatment of diabetic gastroparesis. Allergan has demonstrated category leadership in several gastrointestinal disorders (GI) and shown continued commitment to innovate and advance science and treatments for unmet medical needs.
Cenicriviroc (CVC) is a once-daily, oral Phase 3 ready, potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in inflammatory and fibrogenic pathways for the treatment of non-alcoholic steatohepatitis (NASH). Allergan has demonstrated category leadership in several gastrointestinal disorders (GI) and shown continued commitment to innovate and advance science and treatments for unmet medical needs. Currently, NASH is an adjacent extension of Allergan's broad GI portfolio and represents one of the greatest unmet medical needs. There is currently no approved treatment for NASH.
About Allergan plc
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 16,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
For more information, visit Allergan's website at www.Allergan.com
This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about prevalence and unmet need. Each forward‐looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include those related to preclinical and clinical development, manufacturing and formulation development; the risk that future clinical studies need to be discontinued for any reason, including safety, tolerability, enrollment, manufacturing or economic reasons; the risk that findings from our completed nonclinical and clinical studies may not be replicated in later studies; efficacy, safety and tolerability; decisions by regulatory authorities; those risks related to competition and future business decisions made by us and our competitors or potential competitors; developments in the intellectual property landscape; and the risks listed under the heading "Risk Factors" and elsewhere in Ironwood's Annual Report on Form 10-K for the year ended December 31, 2016, Allergan's Annual Report on Form 10-K for the year ended December 31, 2016 and in the subsequent SEC filings of each company. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Ironwood and Allergan undertake no obligation to update these forward-looking statements.
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