Data Include Week 48 Results from Phase 2B
Study Evaluating MK-8591 in Combination with Doravirine
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, announced today that the results from studies evaluating
MK-8591, an investigational nucleoside reverse transcriptase
translocation inhibitor (NRTTI), are scheduled to be presented at
the 10th International AIDS Society Conference on HIV Science (IAS
2019) taking place July 21 – 24, 2019 in Mexico City.
“Building upon our proud heritage in HIV, we are excited to
share these latest findings for MK-8591,” said Dr. Roy Baynes,
senior vice president and head of global clinical development,
chief medical officer, Merck Research Laboratories. “Based upon the
Phase 2B results to be presented at IAS 2019, our company plans to
initiate Phase 3 trials evaluating MK-8591 with doravirine for the
treatment of HIV-1.”
Abstracts to be presented at IAS 2019
- MK-8591, at doses of 0.25 to 2.25 mg QD, in combination with
doravirine establishes and maintains viral suppression through 48
weeks in treatment-naïve adults with HIV-1 infection. Late-breaking
Oral Presentation. Wednesday, July 24, 11:00-12:30 CDT. Abstract
WEAB0402LB. J-M Molina et al.
- First-in-human trial of MK-8591-eluting implants demonstrates
concentrations suitable for HIV prophylaxis for at least one year.
Late-breaking Oral Presentation. Tuesday, July 23, 16:30-18:00 CDT.
Abstract TUAC0401LB. R. Matthews et al.
- Tolerability, safety and efficacy of MK-8591 at doses of 0.25
to 2.25 mg QD, in combination with doravirine and lamivudine
through 24 weeks in treatment-naïve adults with HIV-1 infection.
Late-breaking Poster Presentation. Tuesday, July 23, 12:30-14:30
CDT. Abstract LBPED46. J-M Molina et al.
- Cellular Modulation and HIV reactivation in response to serial
treatment of latently HIV-infected CD4 T cells with Histone
Deacetylase inhibitors (HDACi). Poster Presentation. Wednesday,
July 24, 12:30-14:30 CDT. Abstract WEPEA044. J. Maxwell et al.
For more information, please visit the IAS 2019 website.
Doravirine is marketed as PIFELTRO® in the United States.
PIFELTRO (doravirine, 100 mg) is a once-daily non-nucleoside
reverse transcriptase inhibitor (NNRTI) to be administered in
combination with other antiretroviral (ARV) medicines currently
indicated for the treatment of HIV-1 infection in adult patients
not previously treated with antiretroviral therapy. PIFELTRO was
approved by the U.S. Food and Drug Administration (FDA) on August
30, 2018 to be administered in combination with other
antiretrovirals for the treatment of HIV-1 infection in adult
patients with no prior ARV treatment experience. A supplemental New
Drug Application is under review by the FDA for use (in combination
with other antiretrovirals) in people living with HIV-1 who are
switching from a stable antiretroviral regimen and whose virus is
suppressed (HIV-1 RNA <50 copies/mL). The Prescription Drug User
Fee Act (PDUFA) date is Sept. 20, 2019.
Selected Safety Information about PIFELTRO
(doravirine)
PIFELTRO is contraindicated when co-administered with drugs that
are strong cytochrome P450 (CYP)3A enzyme inducers (including the
anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, and
phenytoin; the androgen receptor inhibitor enzalutamide; the
antimycobacterials rifampin and rifapentine; the cytotoxic agent
mitotane; and the herbal product St. John’s wort (Hypericum
perforatum)), as significant decreases in PIFELTRO plasma
concentrations may occur, which may decrease the effectiveness of
PIFELTRO. Immune reconstitution syndrome can occur, including the
occurrence of autoimmune disorders with variable time to onset,
which may necessitate further evaluation and treatment.
Co-administration of PIFELTRO with efavirenz, etravirine or
nevirapine is not recommended. If co-administered with rifabutin,
increase PIFELTRO dosage to one tablet twice daily (approximately
12 hours apart).
Consult the full Prescribing Information prior to and during
treatment for important potential drug-drug interactions. The
safety of PIFELTRO is based on two studies, DRIVE-FORWARD and
DRIVE-AHEAD. In DRIVE-FORWARD, the most common adverse reactions
(incidence ≥5%, all intensities) were nausea (7%), headache (6%),
fatigue (6%), diarrhea (5%) and abdominal pain (5%). In
DRIVE-AHEAD, the most common adverse reactions (incidence ≥5%, all
intensities) were dizziness (7%), abnormal dreams (5%) and nausea
(5%).
There is a pregnancy exposure registry that monitors pregnancy
outcomes in individuals exposed to PIFELTRO during pregnancy.
Healthcare providers are encouraged to register patients by calling
the Antiretroviral Pregnancy Registry at 1-800-258-4263. Mothers
infected with HIV-1 should be instructed not to breastfeed if they
are receiving PIFELTRO (doravirine) due to the potential for HIV-1
transmission.
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-1 infection
in combination with other antiretrovirals, as well as for
pre-exposure prophylaxis of HIV-1 infection as a single
investigational agent, across a variety of formulations.
Our 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 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
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 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 2018
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).
Please see Prescribing Information for PIFELTRO (doravirine)
at:
https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_pi.pdf;
and Patient Information for PIFELTRO (doravirine) at:
https://www.merck.com/product/usa/pi_circulars/p/pifeltro/pifeltro_ppi.pdf
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