Superiority of deucravacitinib was
demonstrated on both co-primary endpoints and multiple key
secondary endpoints in the POETYK PSO-2 trial
The overall safety profile remains
consistent with previously reported results and consistent with the
mechanism of action of deucravacitinib, an oral selective tyrosine
kinase 2 (TYK2) inhibitor
Bristol Myers Squibb (NYSE:BMY) today announced positive results
from POETYK PSO-2, the second pivotal Phase 3 trial evaluating
deucravacitinib, a novel, oral, selective tyrosine kinase 2 (TYK2)
inhibitor, for the treatment of patients with moderate to severe
plaque psoriasis. POETYK PSO-2 evaluated deucravacitinib 6 mg once
daily and met both co-primary endpoints versus placebo, with
significantly more patients achieving Psoriasis Area and Severity
Index (PASI 75), defined as at least a 75 percent improvement of
baseline PASI, and a static Physician's Global Assessment (sPGA)
score of clear or almost clear (sPGA 0/1) after 16 weeks of
treatment with deucravacitinib.
The trial also met multiple key secondary endpoints, including
showing deucravacitinib 6 mg once daily was superior to Otezla®
(apremilast) in the proportion of patients reaching PASI 75 and
sPGA 0/1 at Week 16. The overall safety profile of deucravacitinib
in POETYK PSO-2 remains consistent with previously reported results
and consistent with the mechanism of action of deucravacitinib.
Dr. Bruce Strober, M.D., Ph.D., Clinical Professor of
dermatology at Yale University School of Medicine and Central
Connecticut Dermatology, commented, “I am excited to see that the
results from this second pivotal trial further support the
promising efficacy and safety profile of deucravacitinib. This
represents an important step for the over 100 million people living
with psoriasis worldwide, many of whom remain undertreated and are
in need of new, effective oral therapies.”
POETYK PSO-2 is the second of two global Phase 3 studies
demonstrating superiority of once daily deucravacitinib compared to
placebo and Otezla in patients with moderate to severe plaque
psoriasis. Positive topline results from the first Phase 3 trial,
POETYK PSO-1, were announced in November 2020. The company and key
investigators will complete a full evaluation of the POETYK PSO-2
data and share the detailed results at a future medical
meeting.
“Deucravacitinib was designed to be a selective TYK2 inhibitor
that inhibits the IL-12, IL-23 and Type 1 IFN pathways, which are
implicated in multiple immune-mediated diseases. The superior
efficacy we have observed in patients with moderate to severe
psoriasis, combined with the well-tolerated safety profile, are
consistent with the novel mechanism of action of deucravacitinib, a
potential new class of molecule,” said Samit Hirawat, M.D.,
executive vice president, chief medical officer, global drug
development, Bristol Myers Squibb. “The encouraging data we have
seen to date suggest deucravacitinib may become an important oral
treatment option for people living with psoriasis. We look forward
to discussing the results from the POETYK PSO-1 and POETYK PSO-2
registrational studies with health authorities, with the goal of
offering this novel therapy to those suffering from this serious
disease as soon as possible.”
Bristol Myers Squibb thanks the patients and investigators who
participated in the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical
trials.
About Deucravacitinib
Deucravacitinib is the first and only novel, once daily, oral,
selective tyrosine kinase 2 (TYK2) inhibitor in clinical studies
across multiple immune-mediated diseases. Bristol Myers Squibb
scientists designed deucravacitinib to be a selective TYK2
inhibitor, inhibiting interleukin (IL)-12, IL-23 and Type 1
interferon (IFN) pathways, which are implicated in the pathogenesis
of psoriasis and other immune-mediated diseases. Deucravacitinib
achieves selectivity by binding to the regulatory domain of TYK2,
which is structurally distinct from the Janus kinase (JAK) 1, 2 and
3 kinases. Deucravacitinib does not inhibit JAK 1, 2, 3 at
clinically relevant concentrations. Due to the innovative design of
deucravacitinib, Bristol Myers Squibb earned recognition with the
2019 Thomas Alva Edison Patent Award for the science underpinning
the clinical development of deucravacitinib.
Deucravacitinib is being studied in multiple immune-mediated
diseases, including psoriasis, psoriatic arthritis, lupus and
inflammatory bowel disease. In addition to POETYK PSO-1 and POETYK
PSO-2, Bristol Myers Squibb is evaluating deucravacitinib in three
other Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462);
POETYK PSO-4 (NCT03924427); POETYK PSO-LTE (NCT04036435).
Deucravacitinib is not approved for any use in any country.
About the Phase 3 POETYK PSO-1 and POETYK PSO-2
Studies
PrOgram to Evaluate the efficacy and safety
of deucravacitinib, a selective TYK2 inhibitor (POETYK)
PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) are global Phase
3 studies designed to evaluate the safety and efficacy of
deucravacitinib compared to placebo and Otezla® (apremilast) in
patients with moderate to severe plaque psoriasis. Both POETYK
PSO-1, which enrolled 666 patients, and POETYK PSO-2, which
enrolled 1,020 patients, are multi-center, randomized, double-blind
trials that evaluated deucravacitinib (6 mg once daily) compared
with placebo and Otezla (30 mg twice daily). POETYK PSO-2 included
a randomized withdrawal and retreatment period after Week 24.
The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2
were the percentage of patients who achieved Psoriasis Area and
Severity Index (PASI) 75 and the percentage of patients who
achieved static Physician's Global Assessment (sPGA) score of 0 or
1 at Week 16 versus placebo. Key secondary endpoints of the trials
included the percentage of patients who achieved PASI 75 and sPGA
0/1 compared to Otezla at Week 16.
About Psoriasis
Psoriasis is a widely prevalent, chronic, systemic
immune-mediated disease that substantially impairs patients’
physical health, quality of life and work productivity. Psoriasis
is a serious global problem, impacting at least 100 million people
worldwide. Up to 90 percent of patients with psoriasis have
psoriasis vulgaris, or plaque psoriasis, which is characterized by
distinct round or oval plaques typically covered by silvery white
scales. People with psoriasis can experience social stigma that can
lead to significant psychological distress, while accompanying pain
can cause functional disability and reduced quality of life.
Psoriasis is associated with multiple comorbidities that are known
to reduce life expectancy, including cardiovascular disease,
metabolic syndrome, obesity, diabetes, inflammatory bowel disease,
depression and malignancies.
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, Facebook and
Instagram.
Celgene and Juno Therapeutics are wholly owned subsidiaries of
Bristol-Myers Squibb Company. In certain countries outside the
U.S., due to local laws, Celgene and Juno Therapeutics are referred
to as, Celgene, a Bristol Myers Squibb company and Juno
Therapeutics, a Bristol Myers Squibb company.
Otezla® (apremilast) is a registered trademark of Amgen Inc.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding, among other things, the research, development and
commercialization of pharmaceutical products. All statements that
are not statements of historical facts are, or may be deemed to be,
forward-looking statements. Such forward-looking statements are
based on historical performance and current expectations and
projections about our future financial results, goals, plans and
objectives and involve inherent risks, assumptions and
uncertainties, including internal or external factors that could
delay, divert or change any of them in the next several years, that
are difficult to predict, may be beyond our control and could cause
our future financial results, goals, plans and objectives to differ
materially from those expressed in, or implied by, the statements.
These risks, assumptions, uncertainties and other factors include,
among others, that future study results will be consistent with the
results to date, that deucravacitinib (BMS-986165) may not receive
regulatory approval for the indication described in this release in
the currently anticipated timeline or at all and, if approved,
whether such product candidate for such indication described in
this release will be commercially successful. No forward-looking
statement can be guaranteed. Forward-looking statements in this
press release should be evaluated together with the many risks and
uncertainties that affect Bristol Myers Squibb’s business and
market, particularly those identified in the cautionary statement
and risk factors discussion in Bristol Myers Squibb’s Annual Report
on Form 10-K for the year ended December 31, 2019, as updated by
our subsequent Quarterly Reports on Form 10-Q, Current Reports on
Form 8-K and other filings with the Securities and Exchange
Commission. The forward-looking statements included in this
document are made only as of the date of this document and except
as otherwise required by applicable law, Bristol Myers Squibb
undertakes no obligation to publicly update or revise any
forward-looking statement, whether as a result of new information,
future events, changed circumstances or otherwise.
corporatefinancial-news
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210202005374/en/
Bristol Myers Squibb Media Inquiries: media@bms.com Kirby Hosea
Kirby.Hosea@bms.com Investors: Tim Power 609-252-7509
Timothy.Power@bms.com Nina Goworek 908-673-9711
Nina.Goworek@bms.com
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Aug 2024 to Sep 2024
Bristol Myers Squibb (NYSE:BMY)
Historical Stock Chart
From Sep 2023 to Sep 2024