Results from this study support the safety
profile of oral islatravir PrEP regimen through 24 weeks versus
placebo
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced results from a Phase 2a clinical trial
evaluating the safety, tolerability and pharmacokinetics (PK) of
six monthly oral doses, over 24 weeks, of islatravir, the company’s
investigational nucleoside reverse transcriptase translocation
inhibitor, versus placebo for pre-exposure prophylaxis (PrEP) of
HIV-1 infection in adults at low-risk of contracting HIV-1. After
24 weeks, once-monthly oral islatravir was generally well tolerated
versus placebo. Most adverse events (AEs) were mild and there were
no serious drug-related AEs in people who received islatravir. The
levels of islatravir in peripheral blood mononuclear cells (PBMCs)
also remained above the pre-specified efficacy PK threshold for
PrEP at both doses studied (60 mg and 120 mg) eight weeks after the
last study dose. These data were shared as a late-breaking oral
presentation during the virtual 11th International AIDS Society
Conference on HIV Science (IAS 2021) and are a follow-up to the
interim analysis that was presented earlier this year at the
virtual 2021 HIV Research for Prevention Conference (HIVR4P
2021).
“The 24-week analysis of investigational, once-monthly oral
islatravir not only builds upon the PK data we have already seen,
but also provides encouraging support for the safety and
tolerability profile of this HIV-1 PrEP regimen,” said Dr. Joan
Butterton, vice president, global clinical development, infectious
diseases, Merck Research Laboratories. “As part of our commitment
to understanding the potential for our HIV medicines in a broad
range of patients, we focused on the enrollment of diverse patient
populations at risk for HIV, including women, who have one of the
highest unmet needs in HIV prevention.”
Islatravir is currently being evaluated across a variety of
dosing regimens, for both the treatment of HIV-1 infection in
combination with other antiretroviral agents and for the prevention
of HIV-1 infection as a monotherapy. An overview of the islatravir
treatment and prevention development program is available here,
which includes our two Phase 3 IMPOWER trials evaluating islatravir
as once-monthly oral PrEP across diverse populations of people who
may benefit from additional HIV-1 prevention options.
Phase 2a Oral Study Results for Investigational
Islatravir
In the ongoing Phase 2a (NCT04003103) randomized, double-blind,
parallel assignment, placebo-controlled, multicenter trial in
adults at low-risk for acquiring HIV-1 infection, participants were
randomly assigned (2:2:1) to one of three oral once-monthly therapy
groups: islatravir 60 mg, islatravir 120 mg or placebo.
Participants received once monthly oral doses of islatravir or
placebo over a 24-week blinded therapy period, followed by a
12-week blinded follow-up in all groups and a 32-week unblinded
follow-up in the islatravir groups to characterize the terminal
elimination phase. Outcome measures for safety, tolerability and PK
will be analyzed through week 68.
Of the 242 randomized participants at this 24-week analysis,
which concludes the dosing portion of the study, 92% (n=222/242)
completed dosing and 8% (n=20/242) discontinued the study
intervention before week 24. Less than 1% (n=2) of participants
discontinued due to an AE. Of the total participants, 67.4%
(n=163/242) were female, 52.9% (n=128/242) were white, 41.7%
(n=101/242) were Black or African American and 14.9% (n=36/242)
were Hispanic or Latino. Unblinded safety data showed that both
doses of islatravir were generally well tolerated versus placebo
over 24 weeks and most AEs were mild (73.5%). The most common AEs
(occurring in >5% of participants)
in the islatravir 60 mg, islatravir 120 mg and placebo groups
respectively were headache (10.3% [n=10/97], 9.3% [n=9/97] and 4.2%
[n=2/48]), diarrhea (5.2% [n=5/97], 5.2% [n=5/97] and 8.3%
[n=4/48]) and nausea (5.2% [n=5/97]), 7.2% [n=7/97] and 4.2%
[n=2/48]). There were no serious drug-related AEs in people who
received islatravir. The study enrolled a population at low-risk
for HIV infection as evidenced by no confirmed HIV infections
occurring during the treatment period.
The PK analysis showed that trough concentrations (the lowest
level between doses) of islatravir triphosphate in PBMCs following
either 60 mg or 120 mg monthly doses continue to remain above the
pre-specified PK threshold for HIV-1 prophylaxis of 0.05 pmol/106
PBMCs and were sustained through eight weeks after the last dose of
islatravir.
About Islatravir (MK-8591)
Islatravir (MK-8591) is Merck’s investigational nucleoside
reverse transcriptase translocation inhibitor under evaluation in
clinical trials for the treatment of HIV-1 infection in combination
with other antiretrovirals, including the ILLUMINATE clinical
trials program for once-daily treatment. Islatravir is also being
studied for pre-exposure prophylaxis (PrEP) of HIV-1 infection as a
single agent across a variety of formulations, including the
IMPOWER clinical trials evaluating an oral once-monthly
regimen.
Our Commitment to HIV
For more than 35 years, Merck has been committed to scientific
research and discovery (R&D) in HIV. Today, we are developing a
series of antiviral options designed to help people manage HIV and
protect people from HIV, with the goal of reducing the growing
burden of infection worldwide. We remain committed to working
hand-in-hand with our partners in the global HIV community to
address the complex challenges that impede progress toward ending
the epidemic.
About Merck
For 130 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
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline products that
the products will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of the global outbreak of novel coronavirus disease
(COVID-19); the impact of pharmaceutical industry regulation and
health care legislation in the United States and internationally;
global trends toward health care cost containment; technological
advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining
regulatory approval; the company’s ability to accurately predict
future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign
risk; dependence on the effectiveness of the company’s patents and
other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2020
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
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