First Wave of Phase III Development Programme for Grazoprevir/Elbasvir is Fully Enrolled; Merck Plans to Submit NDA in 2015
Merck (MSD outside the US and Canada) has announced the presentation of results from a multi-arm Phase II
clinical trial evaluating grazoprevir/elbasvir (MK-5172/MK-8742, the company’s investigational NS3/4A protease inhibitor and NS5A inhibitor, respectively) with or without ribavirin (RBV) in treatment-naïve and previously-treated (with peg-interferon/ribavirin [PR]) patients with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection -- the C-WORTHy study (Parts A and B).
The final results were presented in oral sessions at the 65th American Association for the Study of Liver Diseases (AASLD) Annual Meeting (also known as The Liver Meeting) and published as separate papers online in The Lancet.
“Merck is committed to developing an efficacious, well-tolerated therapy suitable for a broad spectrum of patients with HCV,” said Dr Eliav Barr, Vice President, Infectious Diseases, Merck Research Laboratories. “We are encouraged by the findings for grazoprevir/elbasvir in the C-WORTHy trial and look forward to advancing our broad Phase III programme, which includes hard-to-cure patients that are of the highest need and least studied to date.”
Interim results from the C-WORTHy study were presented in April 2014 at the 49th Annual Meeting of the European Association for the Study of the Liver (EASL) and announced by Merck.
Related News
-
News A Day in the Life of a Start-Up Founder and CEO
At CPHI we work to support Start-Up companies in the pharmaceutical industry and recognise the expertise and innovative angles they bring to the field. Through our Start-Up Programme we have gotten to know some of these leaders, and in this Day in the ... -
News Biopharmaceutical manufacturing boost part of new UK government budget
In their national budget announced by the UK Labour Party, biopharmaceutical production and manufacturing are set to receive a significant boost in capital grants through the Life Sciences Innovative Manufacturing Fund (LSIMF). -
News CPHI Podcast Series: The power of proteins in antibody drug development
In the latest episode of the CPHI Podcast Series, Lucy Chard is joined by Thomas Cornell from Abzena to discuss protein engineering for drug design and development. -
News Amgen sues Samsung biologics unit over biosimilar for bone disease
Samsung Bioepis, the biologics unit of Samsung, has been issued a lawsuit brought forth by Amgen over proposed biosimilars of Amgen’s bone drugs Prolia and Xgeva. -
News CPHI Podcast Series: Why we need to consider women in clinical trials
The latest episode of the CPHI Podcast Series with Lucy Chard covers women's health, specifically women's representation in clinical trials, the associated bias, and the impacts on health for this population. -
News US FDA does not approve MDMA therapy for PTSD, requests more data
The MDMA-based therapeutic developed by Lykos Therapeutics, a California-based Public Benefit Corporation (PBC), has been reviewed and unapproved by the US FDA. The regulator has requested additional phase III trial data for further safety and efficacy... -
News Novartis and Viatris latest facing lawsuit over HeLa cell misuse
Global pharmaceutical companies Novartis and Viatris are the latest hit with a lawsuit claim pertaining to alleged misuse of the ‘HeLa’ cell line from the estate of woman whose cancerous tissue cells were taken without consent. -
News Sanofi invests billions into Frankfurt insulin production site
French pharmaceutical company Sanofi have announced an investment of EUR1.3 billion at their existing BioCampus site in Frankfurt am Main for the expansion of insulin production.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance