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ALLY Trial Demonstrates High Cure Rates for Investigational Daclatasvir and Sofosbuvir Combination among Genotype 3 Hepatitis C Patients
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Daclatasvir+sofosbuvir regimen achieves SVR12 in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 patients
ALLY-3 is the first Phase 3 study of an all-oral, ribavirin-free treatment regimen for genotype 3 HCV patients with a 12-week treatment duration
Genotype 3 is the second most common genotype worldwide and has emerged as one of the most difficult to treat
Saturday, November 8, 2014 9:00 am EST
"Both treatment naïve and treatment experienced patients in the ALLY-3 study achieved high SVR rates. These results are encouraging given that patients with genotype 3 have emerged as among the hardest to treat"
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) today announced late-breaking data from the landmark ALLY Trial investigating a ribavirin-free 12-week regimen of daclatasvir (DCV) in combination with sofosbuvir (SOF) in genotype 3 hepatitis C (HCV) patients, a patient population that has emerged as one of the most difficult to treat. The results of the study, which showed sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naïve and 86% of treatment-experienced patients, will be presented at The Liver Meeting® 2014, the Annual Meeting of The American Association for the Study of Liver Diseases (AASLD), in Boston, MA, November 7 - 11.
"Both treatment naïve and treatment experienced patients in the ALLY-3 study achieved high SVR rates. These results are encouraging given that patients with genotype 3 have emerged as among the hardest to treat," said David R. Nelson, M.D., Professor of Medicine, Molecular Genetics and Microbiology Director, UF Clinical and Translational Science Institute, and Assistant Vice President of Research for the University of Florida. "Genotype 3 is associated with a more rapid progression of disease and remains a challenge to the efficacy of even newer regimens. The ALLY-3 results demonstrate the possibility of bringing a cure to genotype 3 patients in an all-oral, 12-week regimen."
These results build upon the existing body of data on the daclatasvir and sofosbuvir combination. Data from an open-label, randomized study of daclatasvir with sofosbuvir in genotypes 1, 2, and 3 demonstrated that the 24-week regimen of daclatasvir and sofosbuvir (± ribavirin) achieved SVR12 in 89% of patients with genotype 3. The ALLY study presented at The Liver Meeting investigates the regimen for 12 weeks, halving the previous treatment duration. Other ongoing ALLY studies examine diverse HCV populations across all genotypes: cirrhotic and post-liver transplant patients, as well as treatment-naïve and treatment-experienced patients who are co-infected with HIV.
"HCV is a complex disease, and the treatment community needs multiple options to address the remaining unmet medical needs," said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. "Daclatasvir has shown pan-genotypic activity in bench research, a factor which is becoming increasingly important as we learn more about the complexity of HCV. Further, daclatasvir's potential to be combined with many other agents, including sofosbuvir, is significant in continuing to develop additional treatment options that may help patients of all genotypes achieve cure."
In the ALLY-3 study, the daclatasvir and sofosbuvir combination regimen was well tolerated, with no deaths, treatment-related serious adverse events, or discontinuations due to adverse events. The most frequent side effects (≥5%) were headache (19.7%), fatigue (19.1%), nausea (11.8%), diarrhea (8.6%), insomnia (5.9%), abdominal pain and arthralgia (both 5.3%). Additionally, there were 17 (11.2%) treatment failures, with 16 relapses post-treatment and 1 rebound at the end of treatment. There were no viral breakthroughs in this ribavirin-free regimen.
About ALLY-3: Study Design
This Phase 3 open-label clinical trial enrolled 152 genotype 3 HCV patients; 101 treatment-naïve patients and 51 treatment-experienced patients in 2 cohorts each received daclatasvir 60 mg and sofosbuvir 400 mg once daily for 12 weeks, with 24 weeks of follow-up. The primary endpoint was SVR12 rates, defined as HCV RNA < LLOQ target detected or not detected at follow-up week 12 in treatment-naïve and treatment-experienced patients.
About Hepatitis C
Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Approximately 170 million people worldwide are infected with hepatitis C, with an estimated 2.7-3.9 million chronically infected in the United States. Up to 90 percent of those infected with hepatitis C will not spontaneously clear the virus and will become chronically infected. According to the World Health Organization, up to 20 percent of people with chronic hepatitis C will develop cirrhosis; of those, up to 20 percent may progress to liver cancer.
About Genotype 3
Genotype 3 is estimated to affect 54.3 million people and is the second most common worldwide behind genotype 1 (83.4 million). It is now potentially the most difficult-to-treat genotype, and the more aggressive nature of genotype 3 lies in the damage it causes to the liver, as it is associated with progressive disease, increased rates of steatosis and a disproportionately increased risk of hepatocellular carcinoma.
About Bristol-Myers Squibb's HCV Portfolio
Bristol-Myers Squibb's research efforts are focused on advancing late-stage compounds to deliver the most value to patients with hepatitis C. At the core of our pipeline is daclatasvir, a potent pan-genotypic NS5A complex inhibitor (in vitro), which continues to be investigated in multiple treatment regimens and in people with co-morbidities.
Daklinza (daclatasvir) was recently approved in the EU for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults. Daklinza is also approved in Japan in combination with Sunvepra (asunaprevir), a NS3/4A protease inhibitor. The Daklinza+Sunvepra Dual Regimen is Japan's first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic HCV infection, including those with compensated cirrhosis.
In 2013, Bristol-Myers Squibb's investigational all-oral DCV-TRIO regimen (daclatasvir/asunaprevir/beclabuvir) received Breakthrough Therapy Designation in the U.S., which helped to expedite the start of the ongoing Phase 3 UNITY program. Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. In addition to UNITY 1 and 2, both the UNITY-3 study among Japanese treatment-naïve and -experienced genotype 1 patients and UNITY-4, which studies the DCV-TRIO regimen without ribavirin in cirrhotic and non-cirrhotic patients in Korea, Russia and Taiwan, are currently ongoing. The DCV-TRIO regimen is being studied as a fixed-dose-combination treatment with twice daily dosing.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that daclatasvir will receive regulatory approval in the United States, or if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2013, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
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