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.
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.
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.
They said, on April 23rd, that it will be a 30-week trial. I'm only guessing middle of Dec.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.
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.
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.
Hang in there, bro. Hopefully this is it for you!Yeah I have alopecia universalis.
It has taken away every single hair on my body and has caused my fingernails to stop growing and chip away.
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: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