Merck's investigational once-daily formulation of Isentress meets primary and secondary endpoints in pivotal Phase III study
Results to be presented at future medical meeting, and regulatory submissions planned for 2016
Merck (MSD) has announced top-line results from the company’s Phase III pivotal trial, ONCEMRK. ONCEMRK is evaluating an investigational once-daily formulation of Isentress (raltegravir), known as raltegravir 600 mg (to be given as 2 x 600 mg once-daily), for previously untreated HIV-1 infected adults. The study met its primary efficacy endpoint: 1200 mg raltegravir (given as 2 x 600 mg once-daily) was statistically non-inferior to the marketed formulation approved dose of Isentress 400 mg twice-daily, each in combination therapy with Truvada, as assessed by the proportion of patients achieving HIV-1 RNA <40 copies/mL at Week 48. In addition, the secondary endpoints of tolerability and immunologic efficacy (as measured by change from baseline in CD4 cell counts at Week 48) were comparable. Later this year, Merck plans to present detailed findings of the study at an upcoming scientific conference, and to submit applications for licensure to the FDA and the EMA for this investigational new formulation.
Isentress is indicated twice-daily in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients 4 weeks of age and older. The use of other active agents with Isentress is associated with a greater likelihood of treatment response.
“Merck has never wavered in our commitment to develop meaningful therapeutic options for people with HIV-1 infection,” said Dr Eliav Barr, vice president clinical development, infectious diseases, Merck Research Laboratories. "We are pleased that this study has met its primary endpoint and look forward to presenting the data at a future congress.”
Related News
-
News CPHI Frankfurt 2022: Innovator Interview – DSM Biomedical
At CPHI Frankfurt we spoke to Anne-Cecile Bayne, Global Science & Innovation Lead Pharma and Medical Nutrition, and Marc Hendriks, Vice President Strategy & Business Development, on their expertise in nitrosamines and business strategy at DSM Biomedica... -
News New WHO health emergency guidelines expect full transparency from Big Pharma
The WHO are proposing a new set of pandemic guidelines to set out how future global health crises should be handled. -
News Magic mushrooms could be used to treat mental health conditions
A compound found in magic mushrooms, psilocybin, could be used to treat mental health conditions and help patients suffering with severe depression, as shown by the results of the largest study of its kind to date. -
News UK-based partnership to launch DETERMINE study into rare cancer research
UK-based CRO Quanticate is set to partner with Cancer Research UK for the launch of the DETERMINE study focused on testing a range of existing and approved drugs and therapies on rare cancers. -
News FDA approves Thermo Fisher blood tests for wheat and sesame allergies
Both tests have been approved by the US regulator for in vitro diagnostic use -
News QIAGEN launches world’s first syndromic test for monkeypox
The test can distinguish between monkeypox and other diseases that cause similar symptoms. -
News Monkeypox Update: Vaccine shortage, sewage surveillance and global testing
As concern over the monkeypox outbreak continues to rise, we take a look at major developments from the first week of August. -
News CPHI Podcast Series: The importance of novel excipients for innovative drug development
The latest episode in the CPHI Podcast Series dives into the world of novel excipients and explores their importance for innovative drug development.
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