INDIANAPOLIS, Sept. 29, 2015 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today
announced positive top-line results of RA-BEGIN, the third Phase 3
study evaluating the safety and efficacy of baricitinib, an
investigational medicine for patients with moderately-to-severely
active rheumatoid arthritis (RA). The study met its primary
objective of demonstrating non-inferiority of baricitinib
monotherapy to methotrexate monotherapy based on ACR20 response
rate after 24 weeks of treatment. Additionally, baricitinib was
superior to methotrexate based on ACR20 response.
"Too many people with rheumatoid arthritis who are treated with
methotrexate – commonly used across the disease continuum for 25
years – do not achieve adequate disease control, which can cause
disability and impede productivity," said David Ricks, Lilly senior vice president, and
president of Lilly Bio-Medicines. "People living with RA who
achieve adequate disease control can be more active with their
families, in their careers and in their communities – emphasizing
the importance of effective treatment options."
The RA-BEGIN study included patients who had limited or no prior
treatment with methotrexate, and were naïve to other conventional
or biologic disease-modifying antirheumatic drugs (DMARDs). Part of
a larger Phase 3 program of more than 3,000 RA patients at various
points in the RA treatment continuum, RA-BEGIN enrolled nearly 600
patients who were randomized to one of the following treatment
groups:
- Once-weekly oral methotrexate monotherapy
- 4 mg once-daily oral baricitinib monotherapy
- 4 mg once-daily oral baricitinib in combination with
once-weekly oral methotrexate
"The superiority of baricitinib over methotrexate in the
treatment of patients with early RA adds to the positive data
already seen for baricitinib in RA patients with inadequate
responses to traditional DMARDs (RA-BUILD) and biological therapies
(RA-BEACON)," said Rich Levy, M.D.,
chief drug development officer of Incyte. "The sum of these results
further illustrates the therapeutic profile of baricitinib. If
approved, we believe that baricitinib has the potential to be used
across multiple lines of therapy in rheumatoid arthritis."
In RA-BEGIN, the incidence of treatment-emergent adverse events
and serious adverse events, including serious infections, was
similar across treatment groups. No cases of tuberculosis or
gastrointestinal perforation were reported during the study. The
most common adverse events observed were consistent with previous
studies of baricitinib in RA. Discontinuations due to adverse
events were more common in patients receiving the combination of
baricitinib plus methotrexate. A large majority of patients
completing RA-BEGIN opted to participate in a long-term extension
study.
Lilly and Incyte announced top-line results in December 2014 for the first Phase 3 trial of
baricitinib, RA-BEACON, and in February
2015 for the second, RA-BUILD. Data from these studies were
presented at the EULAR annual scientific congress in June 2015. The companies plan to submit
additional detailed data from all three of these studies for
presentation in scientific meetings and publication in
peer-reviewed journals in 2015 and 2016. Topline results of the
fourth Phase 3 study, RA-BEAM, are expected later this year.
About Baricitinib
Baricitinib is a once-daily, oral, selective JAK1 and JAK2
inhibitor. There are four known JAK enzymes: JAK1, JAK2, JAK3 and
TYK2. JAK-dependent cytokines have been implicated in the
pathogenesis of a number of inflammatory and autoimmune diseases,
suggesting that JAK inhibitors may be useful for the treatment of a
broad range of inflammatory conditions. Baricitinib demonstrates
approximately 100-fold greater potency of inhibition against JAK1
and JAK2 than JAK 3 in kinase assays.
In December 2009, Lilly and Incyte
announced an exclusive worldwide license and collaboration
agreement for the development and commercialization of baricitinib
and certain follow-on compounds for patients with inflammatory and
autoimmune diseases. Baricitinib is currently in Phase 3 clinical
development for rheumatoid arthritis and Phase 2 development for
psoriasis and diabetic nephropathy.
About Rheumatoid Arthritis
Rheumatoid arthritis is an autoimmune
disease[i] characterized by inflammation and
progressive destruction of joints.[ii] More
than 23 million people worldwide suffer from
RA.[iii] Approximately three times as many
women as men have the disease. Patients and physicians indicate
there remains an important opportunity to improve patient care.
Current treatment of RA includes the use of non-steroidal
anti-inflammatory drugs, oral disease-modifying anti-rheumatic
drugs such as methotrexate, and injectable biological response
modifiers that target selected mediators implicated in the
pathogenesis of RA.[iv]
About Baricitinib Phase 3 Trials
Lilly and Incyte are conducting four pivotal Phase 3 clinical
trials of baricitinib in patients with moderately-to-severely
active rheumatoid arthritis to support regulatory submission in
most countries. An additional Phase 3 study was initiated to
support clinical development in China. The clinical trial program includes a
wide range of patients including those who are methotrexate naïve,
inadequate responders to methotrexate, inadequate responders to
conventional disease-modifying anti-rheumatic drugs, or inadequate
responders to TNF inhibitors. Four of these five pivotal studies
are expected to be completed by the end of 2015. Patients
completing any of the five Phase 3 studies can enroll in a
long-term extension study. For additional information on this
clinical trial program, please visit
www.clinicaltrials.gov.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company
focused on the discovery, development and commercialization of
proprietary therapeutics for oncology and inflammation. For
additional information on Incyte, please visit the Company's
web site at www.incyte.com.
About Eli Lilly and Company
Lilly is a global
healthcare leader that unites caring with discovery to make life
better for people around the world. We were founded more than a
century ago by a man committed to creating high-quality medicines
that meet real needs, and today we remain true to that mission in
all our work. Across the globe, Lilly employees work to discover
and bring life-changing medicines to those who need them, improve
the understanding and management of disease, and give back to
communities through philanthropy and volunteerism. To learn more
about Lilly, please visit us at www.lilly.com and
newsroom.lilly.com/social-channels. (P-LLY)
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about baricitinib as a potential treatment for patients with
rheumatoid arthritis and reflects Lilly and Incyte's current
beliefs. However, as with any pharmaceutical product, there are
substantial risks and uncertainties in the process of development
and commercialization. There is no guarantee that future study
results will be consistent with study findings to-date, or that
baricitinib will receive regulatory approvals or prove to be
commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly's and Incyte's filings with the
United States Securities and Exchange Commission. Except as
required by law, Lilly and Incyte undertake no duty to update
forward-looking statements to reflect events after the date of this
release.
[i] American College of Rheumatology, Rheumatoid
Arthritis,
http://www.rheumatology.org/practice/clinical/patients/diseases_and_conditions/ra.asp
(Accessed: October 27, 2014)
[ii] Hand Clinics, Advances in the Medical
Treatment of Rheumatoid Arthritis,
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3135413/pdf/nihms305780.pdf
(Accessed: October 27, 2014)
[iii] WHO Global Burden of Disease Report, (table 7,
page 32) 2004,
http://www.who.int/healthinfo/global_burden_disease/GBD_report_2004update_full.pdf
(Accessed Nov. 11, 2014)
[iv] Arthritis Foundation, Medications for Rheumatoid
Arthritis,
http://www.arthritistoday.org/about-arthritis/types-of-arthritis/rheumatoid-arthritis/treatment-plan/medication-overview/ra-medications.php
(Accessed: May 15, 2013)
Refer
to:
|
Celeste Stanley;
celeste_stanley@lilly.com; +1-317-626-8896 (media)
|
|
Phil Johnson;
johnson_philip_l@lilly.com; +1-317-655-6874 (investors)
|
|
Michael Booth, DPhil;
mbooth@incyte.com; +1-302-498-5914
(Incyte)
|
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SOURCE Eli Lilly and Company; Incyte Corporation