Fda Grants Fast Track For Aclaris’ Jak Inhibitors (7/9/18)

champpy

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Does anyone know if ths FDA fast tracking actually costs Aclaris anything? If they are spending big money to get this fast tracked, then im officially excited.
 

alibaba92

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Does anyone know if ths FDA fast tracking actually costs Aclaris anything? If they are spending big money to get this fast tracked, then im officially excited.

any reports on the trial for Androgenetic Alopecia ? People say JAK is bullshjt, that's why no one cares, idk man
 

NewUser

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From Aclaris' April 23 press release
WAYNE, Pa., April 23, 2018 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, today announced the initiation of a Phase 2 open-label study of ATI-502, a topical Janus Kinase (JAK) 1/3 inhibitor (ATI-502 Topical), in patients with androgenetic alopecia (Androgenetic Alopecia), a condition characterized by a genetically determined male/female-pattern baldness.

This trial will evaluate the safety, tolerability and effect of ATI-502 Topical applied twice daily in 24 adult subjects (12 male, and 12 female) with androgenetic alopecia. This 30-week trial will be conducted at 3 investigational centers within the United States.

Sounds like they've started a phase 2 clinical trial using topical ATI-502 for Androgenetic Alopecia with completion date approx. mid December. Then there is mention of "soft JAKinibs" for Androgenetic Alopecia still in development stages.
 

alibaba92

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From Aclaris' April 23 press release


Sounds like they've started a phase 2 clinical trial using topical ATI-502 for Androgenetic Alopecia with completion date approx. mid December. Then there is mention of "soft JAKinibs" for Androgenetic Alopecia still in development stages.

Where did they say mid-December is the completion date for phase 2 ?
 

NewUser

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Where did they say mid-December is the completion date for phase 2 ?
They said, on April 23rd, that it will be a 30-week trial. I'm only guessing middle of Dec.

Eta: I remember Christiano saying the topical version of tofacitinib worked significantly better on mice than ingested form of the drug, and this was a complete surprise to them. She also said whoever picked up her research(now Aclaris) would have to develop a special formulation and carrier to get the drug to penetrate human scalp to remain at the depth of hair follicles longer than a few minutes in order to be effective if it does work in people. Some expertise is required for this she said but doable.
 
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alibaba92

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They said, on April 23rd, that it will be a 30-week trial. I'm only guessing middle of Dec.

Eta: I remember Christiano saying the topical version of tofacitinib worked significantly better on mice than ingested form of the drug, and this was a complete surprise to them. She also said whoever picked up her research(now Aclaris) would have to develop a special formulation and carrier to get the drug to penetrate human scalp to remain at the depth of hair follicles longer than a few minutes in order to be effective if it does work in people. Some expertise is required for this she said but doable.

So, have they done the "special formulation" ? I supposed yes, otherwise, how to do phase 2 ?
 

blehbleh1

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So this is it? The cure is near? OH LORD PLEASE SAVE US ALL PLEASE LORD HAVE MERCY WITH OUR SOULS
 

DanielDüsentrieb

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I m not familiar with the jak stuff but I heard some rumors that the jaks can have some serius side effects...
Does someone know if this rumors are true or just the pesimists making stuff up
 

DanielDüsentrieb

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ATI-50002 seems to be used for many different conditions. Here I listed some trials.

Phase 2 for Androgenetic Alopecia
https://clinicaltrials.gov/ct2/show/NCT03495817
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : October 30, 2018

Phase 2 for Vitiligo (Skin without pigmentation)
https://globenewswire.com/news-rele...-50002-Topical-in-Patients-with-Vitiligo.html
Started December 2017

Phase 2 for AT and AU
https://clinicaltrials.gov/ct2/show/NCT03315689
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : July 15, 2018

So either ATI-50002 is some medicine wonder that can be used for many different conditions or ATI-50002 is not a specific product but a general name for topical jaks.

If I understand this quote from Belgravia right the later is the truth.
https://www.beIgraviacentre.com/blo...-patents-for-tofacitinib-hair-loss-treatment/
Whether the code names ATI-50001 and 50002 refer to any of the suite of JAK inhibitor drugs already patented in the USA and Japan by The Trustees of Columbia University in the City of New York, who have licensed them exclusively to Aclaris Therapeutics, remains to be seen.
 

DanielDüsentrieb

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According to Aclaris Therapeutics, Inc., ‘This data is the first indication that ATI-502 is absorbed through human skin in the clinical setting and engages the target. The results also demonstrate the pharmacodynamic effect of modulating the appropriate genes associated with the interferon gamma pathway and cytotoxic T-lymphocytes, which are 2 of 3 biomarker components of the Alopecia Areata Disease Activity Index (ALADIN) score.

From: https://www.beIgraviacentre.com/blog/positive-reports-from-topical-alopecia-areata-treatment-trial/
So i suppose that is a yes.
 

alibaba92

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ATI-50002 seems to be used for many different conditions. Here I listed some trials.

Phase 2 for Androgenetic Alopecia
https://clinicaltrials.gov/ct2/show/NCT03495817
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : October 30, 2018

Phase 2 for Vitiligo (Skin without pigmentation)
https://globenewswire.com/news-rele...-50002-Topical-in-Patients-with-Vitiligo.html
Started December 2017

Phase 2 for AT and AU
https://clinicaltrials.gov/ct2/show/NCT03315689
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : July 15, 2018

So either ATI-50002 is some medicine wonder that can be used for many different conditions or ATI-50002 is not a specific product but a general name for topical jaks.

If I understand this quote from Belgravia right the later is the truth.
https://www.beIgraviacentre.com/blo...-patents-for-tofacitinib-hair-loss-treatment/
Whether the code names ATI-50001 and 50002 refer to any of the suite of JAK inhibitor drugs already patented in the USA and Japan by The Trustees of Columbia University in the City of New York, who have licensed them exclusively to Aclaris Therapeutics, remains to be seen.

Androgenetic Alopecia trial, expected completion: 30 October 2018, study duration: 26 weeks, and NOW, still RECRUITING ? wtf ?

idk man, if one drug can treat so many diseases, seems like ... snake oil. idk
 

FootyStar

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I really hope it fixes you. I’m reminded sometimes that my puny nw5 is nothing compared to cases such as yours. Priorities first, I hope your type gets cured before typical AA.

Thanks - fingers crossed! :)

Hopefully we'll all be rid of the hair loss problem soon - with Tsuji's treatments and this on the horizon it is certainly an exciting time right now.
 

NewUser

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idk man, if one drug can treat so many diseases, seems like ... snake oil. idk

And all of the diseases targeted by jakinib research have something in common, immunity. It's a new class of drugs they think will treat everything from psoriasis to AA and, hopefully, Androgenetic Alopecia as well. Some research results hint at the possibility that Androgenetic Alopecia *may be partially due to our inmune system causing inflammation. U. Of Manchester scientists recently experimented with a substitute drug for CsA, an immunosuppressive that works to
reduce expression of protein SFRP1, which inhibits the growth of various tissues, including hair follicles. Hopefully jakinibs will work for pattern baldness as well. We will know soon enough. One thing we can be sure of is that with the development of newer jakinibs to treat a wide range of immune-related diseases, the price of jakinibs will fall.
 
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Btg

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Androgenetic Alopecia trial, expected completion: 30 October 2018, study duration: 26 weeks, and NOW, still RECRUITING ? wtf ?

idk man, if one drug can treat so many diseases, seems like ... snake oil. idk
Corticosteroids belonging to the glucocorticoid class influence the body system in several ways, but they are used mostly for their strong anti-inflammatory effects and in conditions that are related to the immune system function such as:

Glucocorticoid corticosteroids are used to treat systemic lupus, severe psoriasis, leukemia, lymphomas, idiopathic thrombocytopenic purpura, and autoimmunehemolytic anemia. These corticosteroids also are used to suppress the immune system and prevent rejection in people who have undergone organ transplant as well as many other conditions.

Fludrocortisone (Florinef), a potent systemic oral mineralocorticoid corticosteroid is used to treat Addison's disease and diseases that cause salt loss as in congenital adrenal hyperplasia. It also is used commonly to treat conditions of low blood pressure (hypotension) although this is not a Food and Drug Administration (FDA) approved indication.
So corticosteroids are snake oil aswell ? Nice logic there mate
 

champpy

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Ok so the FDA fast tracking doesnt necessarily mean this is for Androgenetic Alopecia. It may work well on 1 of the 3 conditions its meant to treat. I guess ill tap the breaks a little.
 

Tano1

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I’m assuming this grows through scarring as well since areata and universalis causes fibrosis of the scalp once follicles have completely fallen.
 
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