KENILWORTH, N.J.–(BUSINESS WIRE) November 16, 2020 — Merck (NYSE: MRK), generally known as MSD exterior of the USA and Canada, at this time introduced a collaboration with the Invoice & Melinda Gates Basis (the muse) the place the muse is committing to offer funding to assist a pivotal Section three examine investigating a once-monthly oral pre-exposure prophylaxis (PrEP)1 choice in ladies and adolescent women at excessive danger for buying HIV-1 an infection in sub-Saharan Africa. The examine, IMPOWER 22, will consider the efficacy and security of islatravir — Merck’s novel investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) below analysis for each therapy and prevention — and is anticipated to start by early 2021. Greater than half of latest HIV infections globally happen in sub-Saharan Africa, with ladies accounting for practically 60 % of latest infections on this area.
“Our collaboration with the Invoice & Melinda Gates Basis exemplifies our shared mission to finish the worldwide HIV epidemic by means of significant improvements in HIV prevention, together with further PrEP choices,” stated Dr. Roy D. Baynes, senior vp and head of worldwide scientific growth, chief medical officer, Merck Analysis Laboratories. “Islatravir is a promising antiviral candidate with proof from ongoing scientific trials to assist its growth as a once-monthly oral PrEP agent. By this collaboration, we will additional discover the potential of islatravir as a part of our work in direction of the collective world public well being purpose of decreasing the variety of new HIV infections.”
“The world won’t be able to finish the HIV epidemic till we will successfully forestall HIV acquisition in at-risk people and populations,” stated Dr. Emilio Emini, director of the TB & HIV program, the Invoice & Melinda Gates Basis. “This collaboration will assist advance HIV science and doubtlessly supply a brand new choice to stop HIV acquisition amongst at-risk ladies, each in sub-Saharan Africa and globally.”
Per the settlement between the muse and Merck, the muse, in its position as a funder, intends to offer grant funding to the Worldwide Scientific Analysis Middle (ICRC) on the College of Washington Division of International Well being, which is collaborating with Merck on the IMPOWER 22 examine. This grant will assist ICRC’s work with skilled trial websites in sub-Saharan Africa to enroll, observe and retain the massive variety of ladies required for this analysis. Merck would be the trial sponsor, chargeable for supplying the drugs, gaining regulatory and customs approvals, and offering operational experience and sources for administration of the trial, similar to web site monitoring and information reporting. Merck might be funding the IMPOWER 22 scientific trial in the USA.
“Globally, ladies proceed to be underserved in HIV analysis and care. In 2019, ladies accounted for 48 % of latest infections, and in 2018, AIDS-related sicknesses remained the main reason for loss of life for girls throughout their reproductive years,” stated Prof. Elizabeth Anne Bukusi, MBChB, PhD, senior principal scientific analysis scientist and co-director of the Analysis Care Coaching Program on the Middle for Microbiology Analysis of The Kenya Medical Analysis Institute, and a trial investigator. “We is not going to flip the tide on HIV globally till we flip the tide on the virus in Africa, and this scientific trial seeks to assist advance this effort by means of its concentrate on ladies, particularly youthful ladies, who stay disproportionately in danger on this continent.”
About IMPOWER Scientific Trials Program
IMPOWER 22is a randomized, active-controlled, double-blind, multisite Section three examine evaluating the efficacy and security of islatravir administered orally once-monthly as PrEP in cisgender ladies who’re at excessive danger for HIV-1 an infection in sub-Saharan Africa and the USA. The lively comparator for this examine, emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), might be administered orally as soon as each day. Roughly 4,500 cisgender ladies and adolescent women, ages 16 by means of 45, might be randomized (stratified by web site and age) in a 1:1 ratio to obtain both islatravir or FTC/TDF at some point of the examine. Info on this examine might be posted shortly on
Merck additionally plans to conduct further research in HIV prevention with islatravir in once-monthly oral PrEP. These research will embrace IMPOWER 24, a world Section three scientific trial to judge islatravir as a once-monthly oral agent for PrEP at websites internationally and amongst different key populations impacted by the epidemic, together with males who’ve intercourse with males (MSM) and transgender ladies.
About Islatravir (MK-8591)
Islatravir (previously MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) at the moment being evaluated in scientific trials for the therapy of HIV-1 an infection together with different antiretrovirals, in addition to for pre-exposure prophylaxis (PrEP) of HIV-1 an infection as a single investigational agent, throughout quite a lot of formulations. In 2012, Merck licensed islatravir (4’-ethynyl-2-fluoro-2’-deoxyadenosine or EFdA) from the Yamasa Company primarily based in Choshi, Japan.
Merck’s Dedication to HIV
For greater than 30 years, Merck has been dedicated to scientific analysis and discovery in HIV, and we proceed to be pushed by the conviction that extra medical advances are nonetheless to return. Our focus is on pursuing analysis that addresses unmet medical wants and helps folks dwelling with HIV and their communities. We stay dedicated to working hand-in-hand with our companions within the world HIV neighborhood to deal with the complicated challenges that hinder continued progress.
In regards to the Invoice & Melinda Gates Basis
Guided by the idea that each life has equal worth, the Invoice & Melinda Gates Basis works to assist all folks lead wholesome, productive lives. In growing international locations, it focuses on enhancing folks’s well being and giving them the prospect to carry themselves out of starvation and excessive poverty. In the USA, it seeks to make sure that all folks—particularly these with the fewest sources—have entry to the alternatives they want to reach college and life. Based mostly in Seattle, Washington, the muse is led by CEO Mark Suzman, below the route of Invoice and Melinda Gates and Warren Buffett.
For greater than 125 years, Merck, generally known as MSD exterior of the USA and Canada, has been inventing for all times, bringing ahead medicines and vaccines for lots of the world’s most difficult ailments in pursuit of our mission to save lots of and enhance lives. We exhibit our dedication to sufferers and inhabitants well being by growing entry to well being care by means of far-reaching insurance policies, applications and partnerships. Immediately, Merck continues to be on the forefront of analysis to stop and deal with ailments that threaten folks and animals – together with most cancers, infectious ailments similar to HIV and Ebola, and rising animal ailments – as we aspire to be the premier research-intensive biopharmaceutical firm on the earth. For extra data, go to and join with us on Twitter, Fb, Instagram, YouTube and LinkedIn.
Ahead-Trying Assertion of Merck & Co., Inc., Kenilworth, N.J., USA
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1 PrEP is a method for individuals who should not have HIV, who’re thought-about high-risk for buying HIV, to stop the an infection. Presently, the one accessible/permitted dosing choice is to take a capsule each day. PrEP has been proven to successfully cut back the danger of HIV an infection from intercourse when taken each day, however is much less efficient if it isn’t taken constantly. (Supply: )
Posted: November 2020