09.22.2017 | Investors

New Data from CENTAUR Phase 2b Clinical Study Supports Continued Development of Cenicriviroc (CVC) in Ongoing Phase 3 AURORA Trial

-- Liver Biopsy Data from New One Year Cohort of Patients Receiving CVC Confirm the Anti-Fibrotic Activity of CVC in Patients with Fibrosis of NASH --
-- In Patients Treated for Two Years, No Significant Difference in Fibrosis Improvement Observed Between CVC and Placebo at Year Two --
-- Majority of Patients with Higher Fibrosis Scores at Baseline Maintained Improvement in Fibrosis Between Year One and Year Two --
-- Safety Profile was Similar to Placebo Over Two Years --

DUBLIN, Sept. 22, 2017 /PRNewswire/ -- Allergan plc (NYSE:AGN) today announced top-line results from new data for the CENTAUR Phase 2b study which supports the anti-fibrotic efficacy and safety of Cenicriviroc (CVC) for the treatment of liver fibrosis in adults with NASH. One year data from the CENTAUR trial was released in 2016. The new data released today includes patients who remained on treatment for two years, as well as patients who received placebo in year one and then crossed-over to CVC for the second year.

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In the placebo patients who crossed over to receive CVC during year two, 20% of patients receiving CVC compared to 13% of patients receiving placebo achieved the combined endpoint of reduction in fibrosis by at least one stage with no worsening of NASH. When looking only at improvement in fibrosis by at least one stage, 35% of CVC patients compared to 20% of patients receiving placebo achieved this endpoint. These results in the placebo crossover group are comparable to the results seen in the one year data previously announced, and support the anti-fibrotic effects of CVC.

In the patients who remained on treatment for two years, there was no significant difference between CVC and placebo in the composite endpoint – reduction in fibrosis by at least one stage with no worsening of NASH. However, in patients with higher baseline fibrosis scores, patients who received CVC had better outcomes during the two year treatment period.

The safety data of CVC was comparable to placebo over the two year timeframe. The most common adverse events greater than 2% frequency were diarrhea, headache, fatigue. The safety data in this analysis were consistent with the findings in the year one CENTAUR trial.

The complete data results from this study will be submitted for presentation at an upcoming scientific conference.

Allergan is currently enrolling patients in a 2,000 patient phase 3 clinical trial of CVC called the AURORA trial. The primary composite endpoint in the AURORA trial is reduction in fibrosis by at least one stage with no worsening of NASH at one year. The company plans to conduct additional subanalyses of the CENTAUR study and will discuss the data with regulatory authorities to determine whether study modifications may be required.

"In this study CVC has demonstrated a clear anti-fibrotic effect in patients with more advanced NASH, the patients who need it most. Equally important, the drug appears to be very safe in this population. At the same time, the study has reinforced the inherent variability in the disease progression in clinical studies of NASH, underscoring our needs to better understand its natural history and to develop biomarkers. The CENTAUR study results are a critical step forward in the development of CVC and a key advance in our efforts to identify effective therapies that halt or slow disease progression," said Scott Friedman, M.D., a lead investigator and Chief of the Division of Liver Diseases, at the Icahn School of Medicine at Mount Sinai.

"These data confirm the safety profile and anti-fibrotic effect of CVC after one year of treatment. Allergan is committed to advancing our portfolio of NASH treatment programs. We have gained important insights from this anaylsis which will further support our progress with CVC. The CENTAUR trial is a first of its kind with three biopsies in patients with NASH disease and liver fibrosis. It will help us greatly understand the natural history of NASH and help bring much needed treatment options to patients," said David Nicholson, Ph.D., Chief Research & Development Officer, Allergan.

About the CENTAUR Study

The CENTAUR study is a two year Phase 2b multinational, randomized, double-blind placebo-controlled study comparing CVC to placebo for the treatment of liver fibrosis in 289 adults with NASH. The trial exclusively enrolled patients with liver fibrosis and included a baseline, year one and year two biopsies. After year one, half of the patients who had received placebo were re-randomized to receive CVC or stay on placebo for year two.

In July 2016 the CENTAUR study year one results of CVC demonstrated a clinically meaningful improvement in fibrosis of at least one stage without worsening of NASH - subjects treated with CVC were twice as likely to meet this endpoint. Safety profiles were similar between CVC and placebo. The only drug-related treatment emergent adverse events Grade >2 and with greater than 2% frequency were Fatigue (2.8%) and Diarrhea (2.1%).

The AURORA phase 3 study is ongoing to confirm the safety and efficacy of CVC for the treatment of liver fibrosis in adult patients with NASH with liver fibrosis (F2 and F3).

About Cenicriviroc (CVC)

CVC is an oral, once-daily, potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are intricately involved in the inflammatory and fibrogenic pathways in NASH known to cause liver damage and often lead to cirrhosis, liver cancer, or liver failure. Because of this unique mechanism of action, targeting two of the main engines driving NASH, CVC has the potential to play a differentiated role in the management of adults with liver fibrosis due to NASH and may form the cornerstone of NASH combination treatment strategies, both as a single agent and in combination with other agents targeting metabolic pathways. CVC has been granted Fast Track status in adults with liver fibrosis due to NASH, the patient population at highest risk of progression to cirrhosis.

About Non-Alcoholic Steatohepatitis (NASH)

NASH is a severe type of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other apparent causes. NASH occurs when the accumulation of liver fat is accompanied by inflammation and cellular damage. The inflammation can lead to fibrosis (scarring) of the liver and eventually progress to cirrhosis, portal hypertension, liver cancer, and eventual liver failure.

NASH is an emerging health crisis impacting 3% to 5% of the U.S. population and 2% to 4% globally, and is the fastest growing cause of liver cancer and liver transplant in the U.S. The increasing prevalence of NASH is attributed to the growing obesity epidemic and the disease is often diagnosed in patients who have diabetes, high cholesterol or high triglycerides. 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 pharmaceutical, device, biologic, surgical and regenerative medicine 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, a model of research and development, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. With this approach, Allergan has built one of the broadest development pipelines in the pharmaceutical industry with 65+ mid-to-late stage pipeline programs currently in development.

Allergan's success is powered by our more than 18,000 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.

Forward-Looking Statement

Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective on existing trends and information as of the date of this release. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Annual Report on Form 10-K for the year ended December 31, 2016 and Allergan's Quarterly Report on Form 10-Q for the period ended June 30, 2017. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.




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