phase 2 release of data expected sept 15, Pfizer will start phase 3 in 2019.  

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how did this one sneak through phase2 without getting mentioned here? 

quick information: PF 06651600 is an oral Jak3 inhibitor. It has also been getting tested for efficacy in treating Crohns, RA, and ulcerative colitis 

https://clinicaltrials.gov/ct2/results?cond=&term=PF-06651600&a...

edit: apparently I posted about it last year and forgot lol

https://www.alopeciaworld.com/forum/topics/clinical-trial-of-pf-066...

Thank u for link..... I will post the results sept 12 & 15

Does that mean you’re participating in this trial?

Someone posted his regrowth results during the trial in the FB group, it was already a year ago. Looked impressing (basically 100% from baseline) and as he reported zero side effects.

Hi,

I just seen this too that it has got BTD ( breakthrough therapy designation) meaning they got 60 days to say yeh or no to approve it ?

Can drugs get approved before phase 3??

KimK have you had good results whilst on this ?

This is exciting because it’s Pfizer’s own drug and will help people get it on the FDA and also great for people in UK and Europe as it says they are working with the EMA.

I just hope it’s a safe and reliable medication that can finally be approved and help people with Alopecia and other immune diseases.

Any update would be greatly appreciated,

Thank you.

Firstly Break Through Technolgy, per the FDA:

https://www.fda.gov/forpatients/approvals/fast/default.htm

and another great write up:

https://weinberggroup.com/blog/fda-expedited-approvals/


Fast track and breakthrough therapy are the most similar programs designed to expedite the development of drugs for serious conditions. The most significant difference in these two programs is related to the type of data needed to substantiate the request. Fast track can be granted based on preliminary data, such as activity in a nonclinical model or pharmacological data, or a mechanistic rationale. Breakthrough therapy must use preliminary clinical data, and therefore activity in a nonclinical model or a mechanistic rationale alone would not be sufficient.

Sponsors should also note the subtle differences in the designation criteria: drugs seeking fast track must only have the potential to address an unmet medical need, while drugs seeking breakthrough therapy must have preliminary data which demonstrate substantial improvement on clinically significant endpoints over available therapies. The benefits of fast track are more frequent meetings with FDA, more frequent written communication from the Agency, and rolling review. Rolling review refers to the ability of FDA to begin review of the NDA as sections are completed, rather than waiting for the entire NDA finalized to begin the review. Breakthrough therapy drugs have all the benefits of fast track drugs, but also are given intensive guidance on an efficient drug development program and have the involvement of FDA senior managers. In a sense, fast track can be thought of as a junior version of breakthrough therapy, and it is not uncommon for a drug with fast track to be granted breakthrough therapy during the drug development process.

Accelerated approval is perhaps the most “different” of the programs for drugs intended to treat a serious disease because it is an approval pathway rather than a designation. An approval pathway is a mechanism to market authorization whereas a designation is granted to a drug based on meeting certain criteria and which provides certain benefits, such as speeding the approval process for priority review designations or providing tax credits and exclusivity for orphan drug designations. Accelerated approval allows for the use of a surrogate endpoint that is reasonably likely to predict clinical benefit or an intermediate clinical endpoint that can be measured earlier than irreversible morbidity or mortality. Drugs using the accelerated approval pathway must also generally provide a meaningful advantage over available therapies. This pathway has been used extensively for drugs to treat cancer and HIV, as one can obtain a relatively good idea of how a treatment is working by measuring tumor size or viral load rather than waiting for long-term survival data. Accelerated approval does have one major caveat; the Sponsor is required to conduct additional clinical trials after the drug is approved to confirm the clinical benefit. Until the benefit has been confirmed in a post-market setting, the labeling has special language to indicate that the use of the drug has not yet been shown to have a clinical benefit. Additionally, if a drug fails to show a clinical benefit after approval, the drug can be removed from the market.

The final expedited program is priority review, which is a requested by the Sponsor with the initial NDA submission. While most NDAs have a 10 month goal date, priority review drugs have a 6 month goal date. In order to qualify for priority review, the Sponsor must show that if approved, the drug would provide a significant improvement in safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition.

Drugs intended to treat an unmet medical need for a serious condition will often use more than one of these programs. A Sponsor wishing to use all four pathways could first seek fast track with nonclinical data, and could then seek breakthrough therapy using clinical data. The Sponsor could then discuss the possibility of using accelerated approval and obtain FDA agreement on endpoints before moving forward with clinical trials. Finally, the Sponsor could request priority review upon the submission of the original NDA.

Given the tremendous benefits of using these programs, it is not surprising that many Sponsors are taking advantage. According to FDA’s Novel New Drugs Summary, 46% of the novel new drugs approved in 2014 were designated as fast track, breakthrough therapy, or both. Drugs granted priority review made up 61% of the novel new drugs, while 20% were approved using accelerated approval. There are many caveats to these programs as well as additional ways to qualify for the benefits, and so Sponsors should review the guidance to see if one of these programs may be appropriate for their drug and to ensure all relevant criteria are met.

Emily Krulewitz is a Consultant at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please reach out to us by email.


I have not been on any clinical trial, I was preparing for A    Topical,  however I have changed my mind and I am waiting for a trial that will offer more significant upside.  I am geek and stock market observer and I worked in Biotech and have a technical degree .  

I have build a spread sheet on new drug trials and results.  Next week will be very exiting with news out of Bristol Myers and Pfizer

Next week at “EADV (European Academy of Dermatology and Venerology

Thank you for the reply KimK! It was very informative. 

This is exciting and so looking forward to what information they release next week ! 

If phase 3 is starting in 2019, do you think this might get approved by 2020? If the drug continues to show great efficiency and safety ? 

I feel this and CTP-543 have a great chance of getting approved by 2020 but that is just my opinion. As CTP-543 has been granted fast track too.

P.s I hope the price of these medications are not rediculous as others have been..

If I don’t catch the information they release next week could you please upload what they say on this thread ? 

Thank you. 

Major Wall Street Analyst expects 5% chance of commercial product by 2022.

cost I expect market pricing -

If a 3 phase trial opens in Feb 2019 and runs a year or 1 1/2 years=Oct 2020.

 then 1 year to analyze and approve data...... Oct 2021 

Timing can be everything.... which is why I changed my mind on the topical trial.  Most of  these trials require a 6 month wash out after participating in an immunosuppressive drug.  If trial is 6 or 9 months long..... that’s a year or 1 1/2 ..... 

5 % chance for an earliest commercial product at 2022? Why so pessimistic? 

Is it because of the patent dispute between Concert and Incyte?

I'd love to see your spreadsheet shared as a google sheet for the community to have for quick information! 

I'm glad I'm not the only one who enjoys aggregating data

This could be the lead horse in the race, what race...........to be the first to market for AA treatment!

This is Pfizer press release:

https://www.pfizer.com/news/press-release/press-release-detail/pfiz...

PFIZER RECEIVES BREAKTHROUGH THERAPY DESIGNATION FROM FDA FOR PF-06651600, AN ORAL JAK3 INHIBITOR, FOR THE TREATMENT OF PATIENTS WITH ALOPECIA AREATA

PHASE II DATA ACCEPTED FOR LATE-BREAKER NEWS SESSION AT 2018 EADV CONGRESS

Wednesday, September 5, 2018 - 8:50am
EDT

Pfizer Inc. (NYSE:PFE) today announced its investigational oral Janus kinase 3 (JAK3) inhibitor PF-06651600received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body.1,2

The Breakthrough Therapy designation for alopecia areata was supported by positive results from a Phase 2 study, which will be presented during the late-breaking news session at the 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris on September 15, 2018. Currently, there are no FDA-approved treatments for alopecia areata, which impacts millions of people worldwide and is often associated with profound psychological consequences.1,2

“We are encouraged by this Breakthrough Therapy designation as it underscores the potential of our JAK3 inhibitor to address a critical unmet need,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “We are continuing to work closely with the FDA on the development process with the goal of bringing this potential new treatment to patients living with alopecia areata as soon as possible.”

Breakthrough Therapy designation was initiated as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) signed in 2012. As defined by the FDA, a Breakthrough Therapy is a drug intended to be used alone or in combination with one or more other drugs to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. If a drug is designated as a Breakthrough Therapy, the FDA will expedite the development and review of such drug.3

Pfizer is also working with the European Medicines Agency (EMA) on the clinical development program for PF-06651600.

About Alopecia Areata

Alopecia areata is an autoimmune disease, characterized by hair loss, often patchy, on the scalp, face, or body.1,2 People suffering from alopecia areata experience symptoms when immune cells attack healthy hair follicles, causing the hair to fall out, often starting with smooth, round patches.1,2 The mean age of onset is between 25 and 35, but it can also impact children and adolescents, and is seen in both sexes and all ethnicities.1,2 More than half of patients with alopecia areata experience poor health-related quality of life and, as a result, the condition may lead to serious psychological consequences, including high levels of depression and anxiety.1

About PF-06651600 and Pfizer’s Kinase Inhibitor Leadership

The JAK pathways are believed to play an important role in inflammatory processes as they are involved in signaling for over 50 cytokines and growth factors, many of which drive immune-mediated conditions.4JAK inhibition offers the potential for new advanced treatment options for these conditions through unique and targeted selectivity.5

“Pfizer strives to continue moving the JAK science forward with development of multiple JAKis with unique selectivity profiles that are being evaluated in clinical trials. These inhibitors have the potential of meeting significant unmet needs in multiple inflammatory conditions,” said Michael Vincent, Chief Scientific Officer, Pfizer Inflammation & Immunology.

PF-06651600 is an oral small molecule that selectively inhibits Janus kinase (JAK) 3.5 PF-06651600 is also under investigation for the treatment of rheumatoid arthritis, Crohn’s disease and ulcerative colitis.

Pfizer has established a leading kinase research capability with multiple unique kinase inhibitor therapies in development. As a pioneer in JAK science, the Company is continuing to advance several investigational programs for molecules with novel selectivity profiles, which, if approved, could potentially deliver transformative therapies for patients. In addition to PF-06651600, Pfizer has the following kinase inhibitors in trials across multiple indications:

  • PF-04965842: A selective JAK1 inhibitor in Phase 3 clinical trials for the treatment of atopic dermatitis(AD)6; PF-04965842 received Breakthrough Therapy designation from the FDA for the treatment of patients with moderate-to-severe AD
  • PF-06700841: A tyrosine kinase 2(TYK2)/JAK1 inhibitor under investigation for the treatment of psoriasis, Crohn’s disease, ulcerative colitis and alopecia areata
  • PF-06650833: An interleukin-1 receptor associated kinase 4 (IRAK4) inhibitor under investigation for the treatment of rheumatoid arthritis
  • PF-06826647: A TYK2 inhibitor under investigation for the treatment of psoriasis and inflammatory bowel disease (IBD)

Working together for a healthier world ®

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of September 5, 2018. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about PF-06651600 and Pfizer’s ongoing investigational programs in kinase inhibitor therapies, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing data; risks associated with preliminary data; the risk that clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate, regulatory authorities may not share our views and may require additional data or may deny approval altogether; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any jurisdictions for any potential indication for PF-06651600 or any other investigational kinase inhibitor therapies; whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted, and, if approved, whether PF-06651600 or any such other investigational kinase inhibitor therapies will be commercially successful; decisions by regulatory authorities regarding labeling, safety and other matters that could affect the availability or commercial potential of PF-06651600 or any other investigational kinase inhibitor therapies; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at  www.sec.gov  and  www.pfizer.com .

1 Villasante Fricke AC, Miteva M. Epidemiology and burden of alopecia areata: a systematic review. Clinical, Cosmetic and Investigational Dermatology. 2015;8:397-403. doi:10.2147/CCID.S53985.
2 Pratt CH, King LE, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nature reviews Disease primers. 2017;3:17011. doi:10.1038/nrdp.2017.11.
3 Food and Drug Administration Fact Sheet Breakthrough Therapies at https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/Signifi... accessed on January 25, 2018
4 Banerjee, S., Biehl, A., Gadina, M. et al. JAK–STAT Signaling as a Target for Inflammatory and Autoimmune Diseases: Current and Future Prospects. Drugs. 2017;77: 521. https://doi.org/10.1007/s40265-017
5 Telliez JB, Dowty ME, Wang L, Jussif J, Lin T, Li L, et al. Discovery of a JAK3-selective inhibitor: functional differentiation of JAK3-selective inhibition over pan-JAK or JAK1-selective inhibition. ACS Chem Biol. 2016;11(12):3442–51. doi:10.1021/acschembio.6b00677.
6 J Med Chem. 2018 Feb 8;61(3):1130-1152. doi: 10.1021/acs.jmedchem.7b01598. Epub 2018 Jan 23.

 

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