Merck to Initiate New Phase 3 Clinical Program with Lower Dose of Daily Oral Islatravir in Combination with Doravirine for Treatment of People with HIV-1 Infection
20 September 2022 - 12:45PM
Business Wire
Phase 2 study evaluating an investigational
weekly oral combination treatment regimen of islatravir and Gilead
Sciences’ lenacapavir to resume with lower dose of islatravir
Monthly oral islatravir development for
pre-exposure prophylaxis (PrEP) to be discontinued; Merck continues
to evaluate other long-acting PrEP candidates
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, announced today that the company will initiate a new Phase
3 clinical program with once-daily islatravir for the treatment of
people with HIV-1 infection. These new Phase 3 studies will
evaluate a once-daily oral combination of doravirine 100 mg and a
lower dose of islatravir (DOR/ISL). One study will evaluate DOR/ISL
in previously untreated adults with HIV-1 infection and two studies
will evaluate DOR/ISL as a switch in antiretroviral therapy (ART)
in adults with HIV-1 infection who are virologically suppressed.
Certain study participants currently enrolled in once-daily
treatment studies with DOR 100 mg/ISL 0.75 mg will have the option
of transitioning to a new study with the lower islatravir dose. The
U.S. Food and Drug Administration (FDA) has reviewed and agreed
with this plan. The investigational new drug application (IND) for
the once-daily oral DOR/ISL treatment program remains under a
partial clinical hold for any studies that would use doses higher
than the dose to be studied in the new Phase 3 program. Refer here
for more information on the islatravir clinical hold.
The Phase 2 clinical trial (NCT05052996) evaluating an
investigational oral once-weekly combination treatment regimen of
islatravir and Gilead’s lenacapavir in adults with HIV-1 infection
who are virologically suppressed will resume under an amended
protocol with a lower dose of islatravir. The IND under which the
islatravir + lenacapavir once-weekly treatment regimen is being
investigated remains under a partial clinical hold for any studies
that would use weekly oral islatravir doses higher than the doses
considered for the revised clinical program. Islatravir and
lenacapavir, in combination, are investigational and not approved
for use. The safety and efficacy of this combination has not yet
been established.
Additionally, after careful evaluation and analysis, Merck will
discontinue the development of once-monthly oral islatravir for
PrEP. Participants in the ongoing Phase 3 PrEP once-monthly oral
studies will continue to be monitored. The company remains
committed to developing compounds for long-acting HIV prevention
and believes in the potential of the nucleoside reverse
transcriptase translocation inhibitor (NRTTI) mechanism. A Phase 1b
study in adults with HIV-1 infection assessing MK-8527, a novel
NRTTI candidate, will commence shortly (NCT05494736). Merck will
continue to engage with key stakeholders as it works to help
address the unmet need in HIV prevention.
“We are grateful to the study investigators and the many
participants in the trials of islatravir. Following extensive
evaluations and consultation with FDA, we are pleased to be able to
initiate our new Phase 3 clinical program to evaluate islatravir
for the treatment of HIV-1 infection,” said Dr. Eliav Barr, senior
vice president and head of global clinical development, chief
medical officer, Merck Research Laboratories. “We continue to
believe in the potential of the NRTTI mechanism and we are
evaluating additional candidates with the goal of helping to
address unmet needs in HIV prevention. As part of this, we are
pleased to continue our partnership with the Bill & Melinda
Gates Foundation as we continue to evaluate potential long-acting
PrEP opportunities.”
Merck’s 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
At Merck, known as MSD outside of the United States and Canada,
we are unified around our purpose: We use the power of leading-edge
science to save and improve lives around the world. For more than
130 years, we have brought hope to humanity through the development
of important medicines and vaccines. We aspire to be the premier
research-intensive biopharmaceutical company in the world – and
today, we are at the forefront of research to deliver innovative
health solutions that advance the prevention and treatment of
diseases in people and animals. We foster a diverse and inclusive
global workforce and operate responsibly every day to enable a
safe, sustainable and healthy future for all people and
communities. 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., Rahway,
N.J., USA
This news release of Merck & Co., Inc., Rahway, 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
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There can be no guarantees with respect to pipeline candidates that
the candidates will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
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actual results may differ materially from those set forth in the
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the impact of the global outbreak of novel coronavirus disease
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Media Contacts:
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Deb Wambold (215) 779-2234
Brian Plummer bplummer@gilead.com
Investor Contacts:
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Steve Graziano (908) 740-6582
Jacquie Ross Investors_relations@gilead.com
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