- Initial data show that treatment with
ruxolitinib plus standard-of-care (SoC) did not prevent
complications in patients with COVID-19 associated cytokine
storm
Incyte (Nasdaq:INCY) today announced that the Phase 3 RUXCOVID
study evaluating the safety and efficacy of ruxolitinib (Jakafi®),
a JAK1/JAK2 inhibitor, plus standard-of-care (SoC) as a treatment
for patients 12 years and older with COVID-19 associated cytokine
storm did not meet its primary endpoint. Initial data show that
there was no reduction in the proportion of patients receiving
ruxolitinib plus SoC who experienced severe complications including
death, respiratory failure requiring mechanical ventilation or
admission to the intensive care unit (ICU) care by Day 29, compared
to SoC treatment alone (12.0% vs. 11.8% [OR: 0.91 [95% CI:
0.48-1.73], P=0.769, respectively)1.
In addition, there was no clinically relevant benefit observed
among secondary and exploratory endpoints, including mortality rate
by Day 29 and time to recovery, defined as the first day a patient
met the criteria for category 0 (Uninfected – No clinical or
virological evidence of infection), 1 (Ambulatory – No limitation
of activities), or 2 (Ambulatory – Limitation of activities) on the
9-point ordinal scale1. Ruxolitinib was generally well tolerated
and no significant safety concerns were identified1. A
comprehensive analysis including safety data is ongoing. The
results of this study do not affect other ongoing non-COVID-19
related ruxolitinib clinical trials or approved uses of
ruxolitinib.
“Given the urgent nature of the COVID-19 pandemic and the need
for treatments for patients hospitalized with severe COVID-19
associated cytokine storm, the results of the RUXCOVID study are
disappointing,” said Steven Stein, M.D., Chief Medical Officer,
Incyte. “However, we hope that these findings will contribute to
the scientific understanding of this complex disease and to the
collective efforts of the biopharma industry to find solutions that
improve outcomes for patients with COVID-19.”
The RUXCOVID study is complete. The data will be further
analyzed to determine any potential impact on other studies of
ruxolitinib in patients with COVID-19, and will be submitted for
publication.
Ruxolitinib (Jakafi®) is approved by the U.S. Food and Drug
Administration for the treatment of polycythemia vera (PV) in
adults who have had an inadequate response to or are intolerant of
hydroxyurea, in adults with intermediate or high-risk myelofibrosis
(MF), including primary MF, post-polycythemia vera MF and
post-essential thrombocythemia MF and for the treatment of
steroid-refractory acute GVHD in adult and pediatric patients 12
years and older. It is marketed by Incyte in the United States;
ruxolitinib (Jakavi®) is licensed to Novartis ex-U.S.
About COVID-19 Associated Cytokine Storm
Cytokine storm is a severe immune overreaction that can be
triggered by a viral infection and can lead to serious
complications, including pneumonia and acute respiratory distress
syndrome (ARDS). Patients with COVID-19 associated cytokine storm
who experience these complications often require intensive care,
including intubation and the use of mechanical ventilation, and are
at an increased risk of mortality. RUXCOVID study patients were
selected based on having pulmonary infiltrates, elevated
respiratory rate or hypoxemia.
About RUXCOVID
RUXCOVID (NCT04362137) was a global, randomized, double-blind,
placebo-controlled, 29-day, multi-center Phase 3 study evaluating
the efficacy and safety of ruxolitinib plus standard of care (SoC)
therapy in patients aged ≥12 years with COVID-19 associated
cytokine storm compared to placebo plus SoC therapy. The study
enrolled 432 patients globally, and randomization was stratified by
geographic region2.
The primary endpoint was the proportion of patients who died, or
developed respiratory failure and required mechanical ventilation
or required intensive care unit (ICU) care by Day 29. Secondary
endpoints were various efficacy assessments including evaluation of
clinical status using a 9-point ordinal scale; in-hospital outcomes
(mortality rate; proportion of patients requiring mechanical
ventilation; duration of hospitalization, ICU stay, supplemental
oxygen, invasive mechanical ventilation); change in the National
Early Warning Score (NEWS2); change in SpO2/FiO2 ratio; proportion
of patients with no oxygen therapy (oxygen saturation of ≥94% on
room air); and safety2.
Eligible patients were randomized 2:1 to receive oral
ruxolitinib 5mg twice daily (BID) or oral-matching placebo for a
total of 14 days. Study treatment was given in combination with SoC
therapy according to the investigator’s clinical judgement. After
14 days of therapy, if clinical signs or symptoms did not improve
or worsen, and the potential benefit outweighed the potential
risks, patients could receive an additional 14 days of study
therapy. In total, patients were followed on study for 29 days
post-randomization2.
The RUXCOVID study was sponsored by Incyte in the United States
and Novartis outside of the United States. For more information,
please visit: https://clinicaltrials.gov/ct2/show/NCT04362137.
To learn more about Incyte’s response to COVID-19, including
information on the 369-DEVENT study, please visit
Incyte.com/COVID-19.
About Jakafi® (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
U.S. FDA for the treatment of polycythemia vera (PV) in adults who
have had an inadequate response to or are intolerant of
hydroxyurea, in adults with intermediate or high-risk myelofibrosis
(MF), including primary MF, post-polycythemia vera MF and
post-essential thrombocythemia MF and for the treatment of
steroid-refractory acute GVHD in adult and pediatric patients 12
years and older.
Jakafi is marketed by Incyte in the United States and by
Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi
is a registered trademark of Incyte Corporation. Jakavi is a
registered trademark of Novartis AG in countries outside the United
States.
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi® (ruxolitinib) may cause your
platelet, red blood cell, or white blood cell counts to be lowered.
If you develop bleeding, stop taking Jakafi and call your
healthcare provider. Your healthcare provider will perform blood
tests to check your blood counts before you start Jakafi and
regularly during your treatment. Your healthcare provider may
change your dose of Jakafi or stop your treatment based on the
results of your blood tests. Tell your healthcare provider right
away if you develop or have worsening symptoms such as unusual
bleeding, bruising, tiredness, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious
infection during treatment with Jakafi. Tell your healthcare
provider if you develop any of the following symptoms of infection:
chills, nausea, vomiting, aches, weakness, fever, painful skin rash
or blisters.
Skin cancers: Some people who take Jakafi have developed
certain types of non-melanoma skin cancers. Tell your healthcare
provider if you develop any new or changing skin lesions.
Increases in cholesterol: You may have changes in your
blood cholesterol levels. Your healthcare provider will do blood
tests to check your cholesterol levels during your treatment with
Jakafi.
The most common side effects of Jakafi include: for
certain types of MF and PV - low platelet or low red blood cell
counts, bruising, dizziness, headache, and diarrhea; and for acute
GVHD – low platelet, red or white blood cell counts, infections,
and fluid retention.
These are not all the possible side effects of Jakafi. Ask your
pharmacist or healthcare provider for more information. Tell your
healthcare provider about any side effect that bothers you or that
does not go away.
Before taking Jakafi, tell your healthcare provider
about: all the medications, vitamins, and herbal supplements
you are taking and all your medical conditions, including if you
have an infection, have or had tuberculosis (TB), or have been in
close contact with someone who has TB, have or had hepatitis B,
have or had liver or kidney problems, are on dialysis, have a high
level of fat in your blood (high blood cholesterol or
triglycerides), had skin cancer or have any other medical
condition. Take Jakafi exactly as your healthcare provider tells
you. Do not change or stop taking Jakafi without first talking to
your healthcare provider.
Women should not take Jakafi while pregnant or planning to
become pregnant. Do not breast-feed during treatment with Jakafi
and for 2 weeks after the final dose.
Full Prescribing Information, which includes a more complete
discussion of the risks associated with Jakafi, is available at
www.jakafi.com.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements
regarding analysis and publication of the RUXCOVID results contain
predictions, estimates and other forward-looking statements. These
forward-looking statements are based on the Company’s current
expectations and subject to risks and uncertainties that may cause
actual results to differ materially, which risks are detailed from
time to time in the Company’s reports filed with the Securities and
Exchange Commission, including its Form 10-Q for the quarter ended
September 30, 2020. The Company disclaims any intent or obligation
to update these forward-looking statements.
1 Data on file. 2 “A Phase 3 Randomized, Double-blind,
Placebo-controlled Multi-center Study to Assess the Efficacy and
Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine
Storm (RUXCOVID).” ClinicalTrials.gov. 2020.
https://clinicaltrials.gov/ct2/show/NCT04362137.
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version on businesswire.com: https://www.businesswire.com/news/home/20201213005030/en/
Incyte Media Catalina
Loveman +1 302 498 6171 cloveman@incyte.com
Nupur Patel, PharmD +1 302 498 5822 npatel@incyte.com
Investors Michael Booth, DPhil +1 302 498 5914
mbooth@incyte.com
Christine Chiou +1 302 274 4773 cchiou@incyte.com
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