Collaboration with the Bill & Melinda
Gates Foundation Seeks to Bring Forward a New HIV Prevention Option
to Help Address the HIV Epidemic with Focus on Women in Sub-Saharan
Africa
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, today announced a collaboration with the Bill & Melinda
Gates Foundation (the foundation) where the foundation is
committing to provide funding to support a pivotal Phase 3 study
investigating a once-monthly oral pre-exposure prophylaxis (PrEP)1
option in women and adolescent girls at high risk for acquiring
HIV-1 infection in sub-Saharan Africa. The study, IMPOWER 22, will
evaluate the efficacy and safety of islatravir -- Merck’s novel
investigational nucleoside reverse transcriptase translocation
inhibitor (NRTTI) under evaluation for both treatment and
prevention -- and is anticipated to begin by early 2021. More than
half of new HIV infections globally occur in sub-Saharan Africa,
with women accounting for nearly 60 percent of new infections in
this region.
“Our collaboration with the Bill & Melinda Gates Foundation
exemplifies our shared mission to end the global HIV epidemic
through meaningful innovations in HIV prevention, including
additional PrEP options,” said Dr. Roy D. Baynes, senior vice
president and head of global clinical development, chief medical
officer, Merck Research Laboratories. “Islatravir is a promising
antiviral candidate with evidence from ongoing clinical trials to
support its development as a once-monthly oral PrEP agent. Through
this collaboration, we can further explore the potential of
islatravir as part of our work towards the collective global public
health goal of reducing the number of new HIV infections.”
“The world will not be able to end the HIV epidemic until we can
effectively prevent HIV acquisition in at-risk individuals and
populations,” said Dr. Emilio Emini, director of the TB & HIV
program, the Bill & Melinda Gates Foundation. “This
collaboration will help advance HIV science and potentially offer a
new option to prevent HIV acquisition among at-risk women, both in
sub-Saharan Africa and globally.”
Per the agreement between the foundation and Merck, the
foundation, in its role as a funder, intends to provide grant
funding to the International Clinical Research Center (ICRC) at the
University of Washington Department of Global Health, which is
collaborating with Merck on the IMPOWER 22 study. This grant will
support ICRC’s work with experienced trial sites in sub-Saharan
Africa to enroll, follow and retain the large number of women
required for this research. Merck will be the trial sponsor,
responsible for supplying the medicine, gaining regulatory and
customs approvals, and providing operational expertise and
resources for management of the trial, such as site monitoring and
data reporting. Merck will be funding the IMPOWER 22 clinical trial
in the United States.
“Globally, women continue to be underserved in HIV research and
care. In 2019, women accounted for 48 percent of new infections,
and in 2018, AIDS-related illnesses remained the leading cause of
death for women during their reproductive years,” said Prof.
Elizabeth Anne Bukusi, MBChB, PhD, senior principal clinical
research scientist and co-director of the Research Care Training
Program at the Center for Microbiology Research of The Kenya
Medical Research Institute, and a trial investigator. “We will not
turn the tide on HIV globally until we turn the tide on the virus
in Africa, and this clinical trial seeks to help advance this
effort through its focus on women, especially younger women, who
remain disproportionately at risk on this continent.”
About IMPOWER Clinical Trials Program
IMPOWER 22 is a randomized, active-controlled, double-blind,
multisite Phase 3 study evaluating the efficacy and safety of
islatravir administered orally once-monthly as PrEP in cisgender
women who are at high risk for HIV-1 infection in sub-Saharan
Africa and the United States. The active comparator for this study,
emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), will be
administered orally once daily. Approximately 4,500 cisgender women
and adolescent girls, ages 16 through 45, will be randomized
(stratified by site and age) in a 1:1 ratio to receive either
islatravir or FTC/TDF for the duration of the study. Information on
this study will be posted shortly on www.clinicaltrials.gov.
Merck also plans to conduct additional studies in HIV prevention
with islatravir in once-monthly oral PrEP. These studies will
include IMPOWER 24, a global Phase 3 clinical trial to evaluate
islatravir as a once-monthly oral agent for PrEP at sites across
the world and among other key populations impacted by the epidemic,
including men who have sex with men (MSM) and transgender
women.
About Islatravir (MK-8591)
Islatravir (formerly MK-8591) is Merck’s investigational
nucleoside reverse transcriptase translocation inhibitor (NRTTI)
currently being evaluated in clinical trials for the treatment of
HIV-1 infection in combination with other antiretrovirals, as well
as for pre-exposure prophylaxis (PrEP) of HIV-1 infection as a
single investigational agent, across a variety of formulations. In
2012, Merck licensed islatravir
(4’-ethynyl-2-fluoro-2’-deoxyadenosine or EFdA) from the Yamasa
Corporation based in Choshi, Japan.
Merck’s Commitment to HIV
For more than 30 years, Merck has been committed to scientific
research and discovery in HIV, and we continue to be driven by the
conviction that more medical advances are still to come. Our focus
is on pursuing research that addresses unmet medical needs and
helps people living with HIV and their communities. We remain
committed to working hand-in-hand with our partners in the global
HIV community to address the complex challenges that hinder
continued progress.
About the Bill & Melinda Gates Foundation
Guided by the belief that every life has equal value, the Bill
& Melinda Gates Foundation works to help all people lead
healthy, productive lives. In developing countries, it focuses on
improving people's health and giving them the chance to lift
themselves out of hunger and extreme poverty. In the United States,
it seeks to ensure that all people—especially those with the fewest
resources—have access to the opportunities they need to succeed in
school and life. Based in Seattle, Washington, the foundation is
led by CEO Mark Suzman, under the direction of Bill and Melinda
Gates and Warren Buffett.
About Merck
For more than 125 years, Merck, known as MSD outside of the
United States and Canada, has been inventing for life, bringing
forward medicines and vaccines for many of the world’s most
challenging diseases in pursuit of our mission to save and improve
lives. We demonstrate our commitment to patients and population
health by increasing access to health care through far-reaching
policies, programs and partnerships. Today, Merck continues to be
at the forefront of research to prevent and treat diseases that
threaten people and animals – including cancer, infectious diseases
such as HIV and Ebola, and emerging animal diseases – as we aspire
to be the premier research-intensive biopharmaceutical company in
the world. For more information, visit www.merck.com and connect
with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA
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USA (the “company”) includes “forward-looking statements” within
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1 PrEP is a way for people who do not have HIV, who are
considered high-risk for acquiring HIV, to prevent the infection.
Currently, the only available/approved dosing option is to take a
pill every day. PrEP has been shown to effectively reduce the risk
of HIV infection from sex when taken daily, but is less effective
if it is not taken consistently. (Source:
https://www.cdc.gov/hiv/risk/prep/index.html)
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