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Pfizer PF 06651600- Breakthrough Technology Jak 3
phase 2 release of data expected sept 15, Pfizer will start phase 3 in 2019.
Replies to This Discussion
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Permalink Reply by kimk on
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Tomorrow BMY will allow public to listen to web cast-see link below.... this is the 2nd most important announcement this week! Pfizer is sat.... I am looking for a link to listen and post.
Press Release
Bristol-Myers Squibb to Take Part in Morgan Stanley Global Health Care Conference
SEP 06, 2018NEW YORK--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE:BMY) will take part in the Morgan Stanley 2018 Global Health Care Conference on Thursday, September 13, 2018, in New York. Giovanni Caforio, M.D., chairman and chief executive officer will make formal remarks about the company and answer questions at 11:10 a.m. EDT.
Investors and the general public are invited to listen to a live webcast of the session at http://investor.bms.com. Materials related to the presentation will be available at the same website at the start of the live webcast. An archived edition of the session will be available later that day.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180906005709/en/
Bristol-Myers Squibb
Media:
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Permalink Reply by singh on
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Thanks Kim this looks good but hoping for some better news from Pfizer !
If you can post a link to listen or even let us all know what they all say please..
Kind regards
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The Bristol Myers announcement, TKY2 BMS-986165, for Psoriasis, this am was “very positive” and maybe a block buster drug. TKY2 BMS-986165 has plans to run clinical trials for AA! The big news is Saturday!
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Thank you for all the info
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Bristol-Myers Squibb’s Novel, Oral, Selective TYK2 Inhibitor Delivered Significant Skin Clearance in Patients with Moderate to Severe Plaque Psoriasis in Phase 2 Trial
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
WEDNESDAY, SEPTEMBER 12, 2018 2:01 AM EDT$BMY announces results of Phase 2 trial in patients with psoriasis at #EADV2018
Tweet thisPRINCETON, N.J.--(BUSINESS WIRE)--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 27thEuropean 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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Hi,
Can someone explain to me what this above information means plz
Kind regards
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The drugs in trial currently will make the 2 drugs currently used off label, seem silly..... greater response and less risk. If you are anxious to use a med do a trial .... we will know more on sat after Pfizer announcement.
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Saturday, September 15, 2018 - 2:00amEDT
Pfizer Inc. (NYSE:PFE) today announced results from its Phase 2a study
of PF-06651600, an oral Janus kinase (JAK) 3 inhibitor, and PF-06700841,
a tyrosine kinase (TYK) 2/JAK1 inhibitor, compared to placebo, in
patients with moderate to severe alopecia areata (AA), an autoimmune
disease characterized by hair loss and often associated with profound
psychological consequences. Both JAK inhibitors met the primary efficacy
endpoint in improving hair regrowth on the scalp relative to baseline at
week 24 (33.6 points and 49.5 points for JAK3 and TYK2/JAK1,
respectively) as measured by the Severity of Alopecia Tool (SALT) score
(100 point scale). The findings were presented during a Late-Breaking
News session at the 27th European Academy of Dermatology and Venereology
(EADV) Congress in Paris, France.“We are pleased with these results and excited by the potential of
kinase inhibition as a new therapeutic target for patients living with
alopecia areata. This is the first well-controlled study of oral JAK
inhibitors in alopecia areata, helping enhance our understanding of this
disease with significant unmet need and advance the science of kinase
inhibition,” said Michael Vincent, M.D, Ph.D., Senior Vice President and
Chief Scientific Officer, Pfizer Inflammation and Immunology.Based on the totality of the data and the emerging clinical profiles,
the investigational JAK3 inhibitor, which was recently granted
Breakthrough Therapy designation from FDA for alopecia areata, is
advancing to the next phase of development for moderate to severe AA and
will continue to be evaluated for rheumatoid arthritis (RA), Crohn’s
disease (CD) and ulcerative colitis (UC). PF-06700841 will continue to
be evaluated for psoriasis (PsO), CD and UC.“People living with alopecia areata face a difficult journey as there
are currently no approved treatments,” said study investigator Rodney
Sinclair, MD, Sinclair Dermatology, Melbourne, Victoria, Australia. “The
results seen with these JAK inhibitors are very encouraging for me as a
clinician as they signal a potential new way to think about the
treatment of alopecia, which may bring hope for patients with this
distressing condition.”About the Study
This Phase 2a, randomized, double-blind, multicenter study evaluates the
efficacy, safety, and tolerability of PF-06651600 and PF-06700841
compared to placebo in patients with moderate to severe AA. Patients
were randomized 1:1:1 to receive: PF-06651600 (200 mg once daily [QD]
for 4 weeks, followed by 50 mg QD for 20 weeks), or PF-06700841 (60 mg
QD for 4 weeks, followed by 30 mg QD for 20 weeks), or placebo.The study found that the placebo-adjusted mean (95% CI) in SALT change
from baseline scores at Week 24 were 33.6 points (21.4, 45.7),
(P PF-06700841, with statistically significant separation from placebo
occurring as early as Week 6 and Week 4, respectively.In addition to meeting the primary efficacy endpoint, the
investigational candidates also met all secondary endpoints in this
study.Overall, adverse event (AE) rates were comparable between treatment
groups. The most common adverse events seen in the study were in the
infections, gastrointestinal and skin/subcutaneous tissue categories.
There were no cases of herpes zoster reactivation.
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