Merck to Present New Data from Studies of Investigational HIV Therapies Doravirine and MK-8591 at CROI 2018
March 01 2018 - 7:00AM
Business Wire
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced that data from studies of Merck’s robust
HIV pipeline, including doravirine, a late-stage investigational
non-nucleoside reverse transcriptase inhibitor (NNRTI), and
MK-8591, an investigational nucleoside reverse transcriptase
translocation inhibitor (NRTTI), a “first of its kind” mechanism to
enter clinical trials, are scheduled to be presented at the
Conference on Retroviruses and Opportunistic Infections (CROI
2018). In addition, Merck scientists will present data from
experiments investigating the mechanisms of formation and
maintenance of HIV reservoirs and the impact of HIV persistence in
the gut on immune recovery during antiretroviral therapy. CROI 2018
is taking place in Boston, Massachusetts, from March 4-7, 2018.
“Merck’s commitment to HIV has never wavered, and we are very
excited about the progress being made in our labs today to both
better understand HIV and to bring forward the next generation of
potential treatments,” said Dr. George Hanna, associate vice
president, clinical research, Merck Research Laboratories.
Presentations include Week 48 subgroup analysis from the pivotal
Phase 3 DRIVE-AHEAD trial evaluating the efficacy and safety of
doravirine (DOR), lamivudine (3TC) and tenofovir disoproxil
fumarate (TDF) in a once-daily fixed-dose combination single tablet
as a complete regimen (DOR/3TC/TDF) for the treatment of HIV-1
infection in treatment-naïve adults. In addition, results from a
Phase 1 study evaluating MK-8591, an investigational nucleoside
reverse transcriptase translocation inhibitor (NRTTI) that
potentially inhibits HIV reverse transcriptase through multiple
mechanisms will be presented in a late breaking abstract
session.
Merck Abstracts at CROI 2018:
- Abstract # 491: Similar Efficacy and
Safety by Subgroup in DRIVE-AHEAD: DOR/3TC/TDF versus EFV/FTC/TDF
- Chloe Orkin
- Poster presentation, Monday, March 5,
2:30 – 4:00 PM, Poster Hall D
- Abstract # 89LB: Low Dose MK-8591
Protects Rhesus Macaques Against Rectal SHIV Infection
- Martin Markowitz
- Late-breaker oral presentation,
Tuesday, March 6, 11:45 AM, Ballroom B
- Abstract # 26: Multiple Daily Doses of
MK-8591 as Low as 0.25 mg Are Expected to Suppress HIV
- Randolph P. Matthews
- Oral presentation, Monday, March 5,
11:00 AM, Auditorium
- Abstract # 158: CD32+ CD4+ T Cells Are
HIV Transcriptionally Active Rather Than a Resting Reservoir
- Mohamed Abdel-Mohsen
- Oral presentation, Wednesday, March 7,
5:45 PM, Ballroom A
- Abstract # 730: Validation of a Chronic
Kidney Disease Risk Score in HIV+ Patients in the US
- Anthony Mills
- Poster presentation, Tuesday, March 6,
2:30 – 4:00 PM, Poster Hall D
- Abstract # 316: A Bispecific Approach
for Targeting Negative Checkpoint Receptors in HIV-1 Latency
- Daniel Gorman
- Poster presentation, Tuesday, March 6,
2:30 – 4:00 PM, Poster Hall A
- Abstract # 383: Higher Rectal p24
Levels Correlate with Poor CD4 Recovery in Treated HIV Infection
- Bonnie J. Howell
- Poster presentation, Wednesday, March
7, 2:30 – 4:00 PM, Poster Hall A
- Abstract # 376: IL-10 Signaling Is a
Key Mechanism of SIV Persistence in ART-Treated Rhesus Macaques
- Maria Pino
- Poster presentation, Wednesday, March
7, 2:30 – 4:00 PM, Poster Hall A
- Abstract # 393: Blinded Evaluation of
Ultrasensitive Assays of HIV in Plasma
- Sheila M. Keating
- Poster presentation, Wednesday, March
7, 2:30 – 4:00 PM, Poster Hall A
About Doravirine
Doravirine (MK-1439, DOR) is an investigational NNRTI being
evaluated by Merck for the treatment of HIV-1 infection. DOR is
being evaluated in several ongoing clinical trials both as a
once-daily single-entity tablet in combination with other
antiretroviral agents in a tailored regimen, and as a once-daily
fixed-dose combination (DOR/3TC/TDF) in a complete single tablet
regimen. Phase 3 trials include DRIVE-FORWARD, a trial comparing
DOR to once-daily ritonavir-boosted darunavir (DRV+r), each
administered in combination with emtricitabine (FTC)/TDF or
abacavir (ABC)/3TC, in treatment-naïve adults; DRIVE-AHEAD, a trial
comparing DOR/3TC/TDF to efavirenz (EFV)/FTC/TDF in treatment-naïve
adults; and DRIVE-SHIFT, a trial evaluating a switch to DOR/3TC/TDF
in HIV-1 infected adults who are currently virologically suppressed
on another antiretroviral regimen. Other ongoing Phase 2 clinical
trials include an evaluation of DOR/3TC/TDF in treatment-naïve
adults with transmitted resistance to NNRTIs and in people
switching from EFV due to intolerability.
Earlier this year, the U.S. Food and Drug Administration (FDA)
accepted for review two New Drug Applications (NDAs) for DOR for
the treatment of HIV-1 infection in treatment-naïve adults. The
submission includes a once-daily single-entity tablet in
combination with other antiretroviral agents in a tailored regimen,
and a once-daily fixed-dose combination (DOR/3TC/TDF) in a complete
single tablet regimen. The FDA has set a target action date of
October 23, 2018, for both applications.
About MK-8591
MK-8591 is Merck’s investigational nucleoside reverse
transcriptase translocation inhibitor (NRTTI) currently being
evaluated in clinical trials for the treatment of HIV infection.
Preclinical evidence indicates that MK-8591 inhibits HIV reverse
transcriptase through multiple mechanisms that are different from
any approved anti-HIV medicines, including traditional nucleoside
reverse transcriptase inhibitors (NRTIs). MK-8591 is being
evaluated in a 3-part Phase 2b dose-ranging trial, DRIVE2SIMPLIFY,
a study of MK-8591 in combination with doravirine.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company 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.
Through our prescription medicines, vaccines, biologic therapies
and animal health products, we work with customers and operate in
more than 140 countries to deliver innovative health solutions. We
also demonstrate our commitment to increasing access to health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer's disease and
infectious diseases including HIV and Ebola. 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
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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
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MerckMedia Contacts:Pamela
Eisele, 267-305-3558orCarmen de Gourville,
267-305-4195orInvestor Contacts:Teri
Loxam, 908-740-1986orMichael DeCarbo, 908-740-1807
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