Efficacy endpoints including ≥75% and 90%
reduction in the Psoriasis Area and Severity Index (PASI 75, PASI
90) were achieved following 12 weeks of treatment with ≥3 mg daily
of BMS-986165
Data published in New England Journal of
Medicine and presented at European Academy of Dermatology and
Venerology Congress
Late-stage development program initiated in
psoriasis and other immune-mediated diseases
Bristol-Myers Squibb Company (NYSE:BMY) today announced results
from a Phase 2 study of BMS-986165, an investigational oral,
selective tyrosine kinase 2 (TYK2) inhibitor, in patients with
moderate to severe plaque psoriasis. Efficacy endpoints including
≥75% and 90% reduction in the Psoriasis Area and Severity Index
(PASI 75, PASI 90) were achieved following 12 weeks of treatment
with ≥3 mg daily of BMS-986165, with a favorable risk-benefit
profile. Nasopharyngitis, headache, diarrhea, nausea and upper
respiratory tract infection were the most common adverse events
(AEs) reported.
These data were published in the New England Journal of Medicine
and presented at the 27th European Academy of Dermatology and
Venerology (EADV) Congress in Paris. In addition, data from the
Phase 2 study describing biomarker changes and the selectivity of
BMS-986165 for TYK2 in relation to clinical responses will be
presented at EADV on Sept. 15, during a late-breaker session.
“Moderate to severe psoriasis remains undertreated and many
patients struggle with insufficient disease control, leaving a
significant need for effective and convenient therapies that can
provide a positive impact on patients' lives,” said Mary Beth
Harler, M.D., head of Innovative Medicines Development,
Bristol-Myers Squibb. “BMS-986165 is a novel, oral, selective TYK2
inhibitor with a distinct mechanism of action that has the
potential to help psoriasis patients control their disease, and is
planned for study in a wide spectrum of immune-mediated
diseases.”
“Currently, patients with moderate to severe psoriasis have a
limited number of oral therapies,” said Dr. Kim Papp, M.D., Ph.D.,
of Probity Medical Research in Waterloo, Ontario and lead author of
the New England Journal of Medicine publication. “Having a
favorable risk-benefit profile and delivering significant skin
clearance and improvements in quality of life measures, these data
suggest that BMS-986165 may be a promising oral option to help
patients control their psoriasis in the future.”
The registrational POETYK (PrOgram to
Evaluate the efficacy and safety of BMS-986165, a selective
TYK2 inhibitor) PSO Phase 3 program for patients with
moderate to severe plaque psoriasis is currently enrolling. Phase 2
trials for patients with systemic lupus erythematosus or Crohn's
disease are also ongoing.
About IM011-011: A Multi-Center, Randomized, Double-Blind,
Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the
Clinical Efficacy and Safety of BMS-986165 in Subjects with
Moderate to Severe Psoriasis
This was a multicenter, randomized (1:1:1:1:1:1), double-blind,
placebo-controlled study in adults with moderate to severe
psoriasis. The trial randomized 267 patients to receive BMS-986165,
a novel, oral, selective TYK2 inhibitor, in doses of 3 mg every
other day (QOD) (n=44), 3 mg every day (QD) (n=44), 3 mg twice
daily (BID) (n=45), 6 mg BID (n=45), 12 mg QD (n=44), or placebo
(n=45). The primary endpoint was PASI 75 at Week 12. Key secondary
endpoints included PASI 90 and PASI 100, as well as Dermatology
Life Quality Index (DLQI), a quality of life measure.
BMS-986165 achieved PASI 75 in 67%-75% of patients in the 3 mg
twice daily and higher dose groups, compared to 7% for placebo at
Week 12. PASI 75 response rates were 7% for placebo, 9% for 3 mg
QOD (P=0.49 vs. placebo), 39% for 3 mg QD (P<0.001), 69% for 3
mg BID (P<0.001), 67% for 6 mg BID (P<0.001), and 75% 12 mg
QD (P<0.001). Efficacy was seen regardless of a patient’s prior
exposure to biologic therapy. Secondary endpoints included PASI 90
(response rates of 2%, 7%, 16%, 44%, 44%, and 43%, respectively)
and complete clearance of lesions (PASI 100; response rates of 0%,
2%, 0%, 9%, 18%, and 25%, respectively). The percentages of
patients in whom a static Physicians Global Assessment (sPGA) score
of 0 (clear) or 1 (minimal disease) was achieved were 64%-76% in
the 3 mg twice daily and higher dose groups compared to 7% in the
placebo group. A higher percentage of patients had a DLQI score of
0 or 1, reflecting a normal or near-normal quality of life, in the
groups receiving 3 mg of BMS-986165 twice daily (42%), 6 mg twice
daily (60%), or 12 mg daily (64%) than in the placebo group
(4%).
There were three serious AEs reported in the active groups and
two in the placebo group. No serious AEs were reported in the
highest dose groups (6 mg twice daily and 12 mg once daily). The
frequency of all treatment-emergent AEs were 55%-80% in the active
groups and 51% in the placebo group. Nasopharyngitis, headache,
diarrhea, nausea and upper respiratory tract infection were the
most common AEs reported.
About BMS-986165 and TYK2
TYK2, an intracellular signaling kinase, mediates
cytokine-driven immune and pro-inflammatory signaling pathways that
are critical in the cycle of chronic inflammation central to
immune-mediated diseases. TYK2 mediates signaling of IL-23, IL-12,
and Type I IFN-driven responses but not cytokine responses mediated
by other kinases, such as IL-6, hematopoietic growth factors and
the IL-2 family. TYK2 signaling is implicated in the
pathophysiology of various immune-mediated diseases including
psoriasis, lupus and inflammatory bowel disease.
BMS-986165 is a novel, oral, selective TYK2 inhibitor with a
unique mechanism of action distinct from other kinase inhibitors,
and is being studied in a wide spectrum of immune-mediated
diseases.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains “forward-looking statements” as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. No forward-looking statement
can be guaranteed. Among other risks, there can be no guarantee
that our TYK2 compound will receive regulatory approval for the
indications described in this release. Forward-looking statements
in this press release should be evaluated together with the many
uncertainties that affect Bristol-Myers Squibb’s business,
particularly those identified in the cautionary factors discussion
in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year
ended December 31, 2017 in our Quarterly Reports on Form 10-Q and
our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no
obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or
otherwise.
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Bristol-Myers SquibbMedia:Chrissy Trank,
609-252-5609christina.trank@bms.comorInvestors:Bill
Szablewski, 609-252-5894william.szablewski@bms.comorTim Power,
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