An innovative all-oral combination therapy for treatment-naïve patients with genotype 1 chronic hepatitis C virus (HCV) has yielded encouraging results during the phase 2a study conducted by Janssen Pharmaceutical Companies’ Alios BioPharma, Inc., according to a recent press release from Achillion Pharmaceuticals, Inc. (NASDAQ: ACHN), the proponents of this therapy.
The interim results, compiled by July 2016, were published as part of the abstracts for the upcoming special conference of the European Association for the Study of the Liver (EASL), scheduled for September 23-24 in Paris. Updated results will be released separately on September 23.
According to Achillion, a science-driven company focused on the discovery and development of innovative treatments for serious diseases, the phase 2a study’s main goal was to identify and confirm the right dosage and treatment duration for an oral combination of Alios BioPharma’s uridine nucleotide analog AL-335 and odalasvir (ODV) without or with simeprevir (SMV). The study looked into the effects, safety and efficacy of various dosages of the combination for durations of six or eight weeks of treatment.
The interim results showed that the AL-335-ODV combination was generally safe and tolerated well by non-cirrhotic HCV patients, whether it included SMV or not. Most side effects noticed in the four study groups were mild and included headaches, fatigue or upper respiratory tract infection. Only one serious side effect was discovered during the trials when one of the patients in Group 1 developed Mobit Type 1 second degree atrioventricular block, but the problem resolved once the combination treatment was discontinued.
Achillion CEO and President Dr. Milind Deshpande welcomed the results of the phase 2a study and voiced appreciation for the significant progress made by Janssen in advancing the new combination treatment. Given that the interim results were encouraging, Janssen will move forward to the next stage of the clinical trials, with a phase 2b program designed to further understand the full potential of this drug combination with the final goal of shortening the duration of HCV treatment.
In phase 2b, patients will be given one daily dose of AL-335 800mg, odalasvir 25mg and simeprevir 75mg. This stage of the study will include people chronically infected with hep C virus genotypes 1, 2, 4, 5 and 6. Separately, a continuation of the phase 2a program will include patients with or without cirrhosis as well as those with genotype 2 and 3 HCV.
Hepatitis C virus infection remains one of the leading causes of liver disease and related mortality, with approximately 150 million people infected worldwide. Roughly three million of these cases are in the United States. If left untreated, chronic hepatitis leads to permanent liver damage, which can result in liver failure, liver cancer or death. Despite the grim outlook and available treatments, there are still significant unmet therapy needs for many HCV patients. In addition, three quarters of the patient population is undiagnosed, making HCV a silent epidemic that poses a major global health threat.
For more information, visit www.Achillion.com
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