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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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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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Permalink Reply by Carl on
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hi Kim, will you please translate this for us? How does the scoring system work? Do these results seem encouraging? Thank you!
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Hi, it means both drugs are working. Translated it means appr. half of the AA is gone after 6 months. We have seen people posting their results in the global FB group. And they were at a zero SALT score after this period of time. Looks very good. These are second generation drug, selecting the target - as opposed to famous Xeljanz which is inhibiting all three JAK pathways. It means less side effects - and less blathering with insurers and random dermatologists about the so-called "risk-benefit-ratio" (meaning they donot want AA to be treated as it is just "cosmetic")
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Wow, that’s great. Does a zero SALT score mean it was 100% effective in the trial patients? Or in other words, how effective was it across the trial patients? Did all see half of the AA gone after six months?
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I think xeljanz is a JAK 1 and 3 and ruxolitinib is a JAK 1 and 2.Im a non responder to xeljanz so I’m hoping a JAK 2 is the answer for me.This is all great news we must be one of the only diseases that doesn’t have one approved drug on the market for treatment.
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Thanks Nor75 for clearing that up! Sounds very interesting. Do you know the name of that Facebook group plz?
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Hi Nor75 I just checked and couldn’t anyone posting an results. But thank you for the info and will keep checking
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1. This may be the first AA treatment product! That’s what it means? High chance this will be 1st to market by Pfizer.
2. The initial safety profile supports patients of AA consider Phase 3 more confidently!
Pfizer's JAK3 PF-06651600 showed placebo-adjusted 33.6-pt mean improvement on the Severity of Alopecia Tool (SALT) score.
There were no serious adverse events (SAEs) and 4% discontinued due to AEs, The most common AEs were infections, GI disorders, and skin and SQ tissue disorders, and most were mild.
These data supported the FDA's granting Breakthrough Therapy designation.
Remember none of this is ganrenteed but best news I have seen.
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Thanks for the information KimK. Still a few years away am guessing but better news nevertheless.
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