Aclaris Announces First Patient Dosed In A Pilot Study With Ati-502 Topical For Aag Pat

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Ollie

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Georgie said:
yeah say if tsuji gets it right and we see completely bald Androgenetic Alopecia sufferers regrowing full heads. I would probably cry. Not even exaggerating. It would mean potentially being able to live my life again.
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Im with you there dude i think we'd all cry, i practically cried just reading your comment.

I dont quite understand how tsuji would be administered though ?.. Would the cells be like sucked up and injected then randomly migrate and form new follicles by themselves or would they have to be implanted 1 by 1 like a normal hair transplant ?
 
Georgie

Georgie

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IdealForehead said:
From what I get from his post he's planning on taking flutamide orally.

Flutamide should probably never be used topically as it's not fully biologically active. It must be converted to hydroxyflutamide to have full activity. This conversion typically occurs in the liver. I don't know if it would happen in the skin.

Incidentally I was just trying to find out what the strength differential of hydroxyflutamide and flutamide was (it's 10-25x) and came across some other interesting points on flutamide from Wikipedia:

"Flutamide has been found to be equal to slightly more potent than cyproterone acetate and substantially more potent than spironolactone as an antiandrogen in bioassays. This is in spite of the fact that it has on the order of 10-fold lower affinity for the AR relative to cyproterone acetate. Flutamide has far lower affinity for the AR than spironolactone and cyproterone acetate, and it is a relatively weak antiandrogen in terms of potency by weight, but the large dosages at which flutamide is used appear to compensate for this."

Comparison table (RBA = relative binding affinity):

View attachment 86708

I find this interesting. It shows how incredibly powerful DHT's affinity for the androgen receptor is even compared to some of our stronger anti-androgens.

I also think the statement that flutamide is roughly equal to cyproterone in practice and both are greater than spironolactone probably makes sense. I can definitely say a full dose of cyproterone feels much stronger than spironolactone. Interesting to conceptualize cypro and flutamide "on the same level" and interesting flutamide can outperform what you'd expect from its low RBA.

As they say, having a low RBA can be compensated for by higher doses. ie. A high enough dose of hydroxyflutamide can still block out DHT despite having only a tiny fraction of its affinity. The max dose will be limited by drug tolerance and toxicity. So flutamide can "catch up" through high doses.

Would love to see how daro fits into that affinity ladder relative to DHT.
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I had read that cpa 50mg was the equivalent strength of 200mg spironolactone, and that flutamide was stronger again. Interestingly enough most of the women who use flutamide for Pcos find it more helpful than anything else. I wonder why that is.
 
Georgie

Georgie

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Ollie said:
Im with you there dude i think we'd all cry, i practically cried just reading your comment.

I dont quite understand how tsuji would be administered though ?.. Would the cells be like sucked up and injected then randomly migrate and form new follicles by themselves or would they have to be implanted 1 by 1 like a normal hair transplant ?
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I believe what happens is that they culture your own hair cells and then create a “germ” which is injected into whichever areas that need treatment and they sort of migrate on their own.
 
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IdealForehead

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Just an interesting note on Aclaris. I've tried to learn a bit more about them. They're essentially from what I can tell a pretty new startup, and their patents on the use of JAK inhibitors topically for hair is one of the major things they have their future pinned on. They only have one product ready for market at the present which is a hydrogen peroxide treatment pen for skin blemishes coming out next month.

However, they acquired the rights to topical JAK inhibitors in 2015 & 2017, for hair loss and other skin conditions, and so now they have a lot riding on that. If the topical JAK inhibitors succeed they will be rich beyond imagination. If they fail, well I guess their investors will have considered it a good gamble.

Here's what I can't figure out:

How does a company with literally ONE finished product that hasn't even been released to market have $300+ million valuation and the capacity to buy out other companies for rights to these topical JAK inhibitors?

They were founded in 2012. They went public in 2015 after getting some topical JAK patents (when they didn't even have a single product to offer). Their first product will be released next month for blemishes, with likely a small market reach expected for it.

Where the f*** is this coming from? I feel like I'm missing something. I don't have a lot of time to read all the documents on their history (here), but from what I gather this is a company built by people with deep financial connections within the pharma/biotech sector almost solely around making a concerted gamble that topical JAK inhibitors will be a game changer for conditions like psoriasis and maybe even hair loss.

Their primary "asset" at the present from what I can tell are their patents for JAK inhibitors for topical use that they have been acquiring since 2015, and that seems to be the only factor that has led to them being valued in the hundreds of millions.

Here's their pipeline:
pipeline.PNG


This is their director, and a bit about his "friends":

Neal Walker co-founded our company and has served as President and Chief Executive Officer and a member of our Board since our inception in July 2012. Dr. Walker co-founded NeXeption, LLC, a biopharmaceutical assets management company, in August 2012. Between July 2011 and July 2012, Dr. Walker served as a consultant to a number of pharmaceutical companies. Dr. Walker co-founded and served as President and Chief Executive Officer and a member of the board of directors of Vicept Therapeutics, Inc., a dermatology-focused specialty pharmaceutical company, from 2009 until its acquisition by Allergan, Inc. in July 2011. Previously, Dr. Walker co-founded and led a number of life science companies, including Octagon Research Solutions, Inc., a software and services provider to biopharmaceutical companies (acquired by Accenture plc), Trigenesis Therapeutics, Inc., a specialty dermatology company, where he served as Chief Medical Officer (acquired by Dr. Reddy's Laboratories Inc.), and Cutix Inc., a commercial dermatology company. He began his pharmaceutical industry career at Johnson and Johnson, Inc. Dr. Walker is a director of Alderya Therapeutics, Inc, a publicly held biotechnology company, as well as several private biotechnology companies.
​
The bios for their whole board of directors reads like this.
 
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orphanfunkhouser

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anybody know how trial participants are selected? I live right down the road from this place. Im tempted to contact the dr. and ask him if i can be his lab rat
 
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zato

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The CEO of the company said this to shareholders in august:

Our Androgenetic Alopecia-201 topical trial is an ongoing Phase 2 open-label clinical trial of ATI-502 for the topical treatment of androgenetic alopecia or Androgenetic Alopecia, also known as male or female pattern hair loss. This ongoing trial will evaluate the efficacy of ATI-502 on the regrowth of hair in up to 24 patients with Androgenetic Alopecia and data are expected in this trial in the first half of 2019.
https://seekingalpha.com/article/41...-results-earnings-call-transcript?part=single

Their advances with Alopecia Areata are promising. We will see with Androgenetic Alopecia.
 
shadowcast

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IdealForehead said:
How does a company with literally ONE finished product that hasn't even been released to market have $300+ million valuation and the capacity to buy out other companies for rights to these topical JAK inhibitors?
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From what I can see, they have raised about $100MM in funding. This is probably less than you think it is. Valuations themselves are essentially pulled out of thin air. If you're trying to tie these impressive looking numbers to the likelihood of this stuff working for Androgenetic Alopecia, then you're in for a let down. If you're just generally confused, then I assure you there is nothing odd about raising hundreds of millions of dollars based on little tangible product. Have you heard of Theranos?
 
anders

anders

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"Androgenetic Alopecia-201 Topical – This ongoing Phase 2 open-label clinical trial is evaluating the safety and efficacy of ATI-502, a topical JAK1/3 inhibitor, on the regrowth of hair in 31 patients with androgenetic alopecia (Androgenetic Alopecia), also known as male/female pattern hair loss. 6-month data are expected in the second quarter of 2019 and 12-month data are expected in the second half of 2019."

Source:
https://www.globenewswire.com/news-...-on-Clinical-and-Commercial-Developments.html
 
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