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Press Release: Follica Announces Progression To Pivotal Study Following Positive Interim Data In Ma

Discussion in 'New Research, Studies, and Technologies' started by itsjustsimon, Jun 13, 2019.

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  1. itsjustsimon

    itsjustsimon Experienced Member My Regimen

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    Nothing new tbh, just nice to see some "official" news.

    Pivotal study expected to begin in late 2019

    PureTech Health has increased its ownership in Follica to 77%

    PureTech Health plc (LSE: PRTC) (“PureTech Health”), an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) axis, is pleased to note that its affiliate, Follica, announced today that it will progress the program to a pivotal study following positive interim data from an ongoing safety and optimisation study in male androgenetic alopecia (male pattern hair loss). In addition to demonstrating tolerability and informing key treatment parameters, the study achieved a visible and statistically significant improvement in non-vellus (visible) hair count after three months of treatment, compared to baseline, according to an analysis of 20 study participants. Additionally, blinded head-to-head bench testing of the proprietary Follica device has shown significant therapeutic advantages in scalp treatment versus commercially available skin disruption devices. A pivotal study is expected to initiate at the end of 2019 subject to continued safety and efficacy in the optimisation study. PureTech Health has increased its ownership in Follica and now holds a 77%i equity stake in the company, in addition to royalties from potential sales.

    Daphne Zohar, founder and chief executive officer of PureTech Health, said: “Follica is an affiliate that we haven’t spoken about as much pending these results, so we are excited to share this positive development as the company prepares to initiate its pivotal study toward the end of this year. The interim analysis showed a robust response to Follica’s proprietary treatment and we believe the company is uniquely positioned to potentially address a tremendous need in a large market.”

    Follica’s platform is designed to induce an “embryonic window” in adult skin via a proprietary form of micro-abrasion that initiates hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process of hair follicle neogenesis is enhanced through the application of a topical compound as part of the treatment regimen. In addition to the ongoing safety and optimisation study, Follica has proof-of-concept data from prior clinical studies using prototype devices with different treatment parameters and therapeutic compounds.

    *Calculated on a diluted basis, including issued and outstanding shares as well as outstanding options to purchase shares, excluding unallocated shares authorised to be issued pursuant to equity incentive plans, and assuming conversion of outstanding promissory notes.

    -

    BOSTON--(BUSINESS WIRE)--Follica, Inc. (“Follica”), a clinical-stage biotech developing a regenerative platform for hair growth, today announced positive interim data from an ongoing safety and optimization study to treat hair loss in male androgenetic alopecia. In addition to being well tolerated and informing key treatment parameters, analysis of 20 male study participants with androgenetic alopecia showed that Follica’s approach achieved a visible and statistically significant improvement in non-vellus (visible) hair count after three months of treatment, compared to baseline. Additionally, blinded head-to-head bench testing of the proprietary Follica device has shown significant therapeutic advantages in scalp treatment versus commercially available skin disruption devices. A pivotal study is expected to initiate at the end of 2019 subject to continued safety and efficacy in the optimization study.

    “Some of my past life was spent trying to stop hair from growing, but I’m equally enthusiastic to have been involved in helping advance and optimize George’s key discovery that shows promise for creating new hair”

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    Follica’s platform is designed to induce an “embryonic window” in adult skin via a proprietary form of micro-abrasion that initiates hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process of hair follicle neogenesis is enhanced through the application of a topical compound as part of the treatment regimen. In addition to the ongoing safety and optimization study, Follica has proof-of-concept data from prior clinical studies using prototype devices with different treatment parameters and therapeutic compounds. Follica’s translational work builds on an important basic discovery by George Cotsarelis, MD, Chair of the Department of Dermatology at the University of Pennsylvania, and a co-founder of Follica.

    “Follica’s pioneering work in new hair formation has the potential to address a tremendous need,” said Ken Washenik, MD, PhD, president of Bosley Medical Group, clinical faculty of Dermatology at NYU school of medicine, and senior medical advisor to Follica. “The unique mechanism of action has been studied extensively and is truly differentiated from existing treatment options. The results I’ve reviewed in the interim analysis are exciting and very strong, and I look forward to the initiation of the pivotal study later this year.”

    “Some of my past life was spent trying to stop hair from growing, but I’m equally enthusiastic to have been involved in helping advance and optimize George’s key discovery that shows promise for creating new hair,” said R. Rox Anderson, MD, PhD, professor of dermatology at Harvard Medical School, director of the Massachusetts General Hospital Laser Center, and scientific advisor to Follica, who conceived and developed many of the non-scarring treatments now widely used in medical and aesthetic care. These include laser treatments for birthmarks, microvascular and pigmented lesions, tattoo and permanent hair removal, as well as cryolipolysis (Coolsculpting®).

    “The biology of wounding in humans is very complex, and our ability to translate its effects into new hair growth is sensitive to a range of treatment factors,” said Jason Bhardwaj, chief executive officer of Follica. “From years of clinical testing, we have optimized the dosing, frequency, and several other important parameters and translated these learnings into a unique and proprietary treatment. Based on this interim analysis and the results of three previously conducted studies, we are excited to move forward into a pivotal study at the end of 2019.”

    The safety and optimization study is an endpoint-blinded, randomized, controlled study designed to evaluate Follica’s proprietary skin disruption device in men with androgenetic alopecia and to establish therapeutic parameters, including the optimal duration and frequency of treatment. The study will continue to enroll up to 60 men, ages 18-40, with moderate grades of androgenetic alopecia (Hamilton Norwood III-IV).

    About Follica
    Follica is a clinical-stage biotech developing a regenerative platform for hair growth. Founded by PureTech Health (LSE: PRTC), a co-inventor of the current platform, and a group of world-renowned experts in hair follicle biology and regenerative medicine, Follica’s device platform has been shown to stimulate the development of new hair follicles and hair in three previously conducted clinical studies. The company’s proprietary device is designed to induce an embryonic window via a device with optimized parameters to create micro-abrasions and initiate hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process is enhanced through the application of a topical compound. Follica is conducting an ongoing optimization trial, with a pivotal study in androgenetic alopecia expected to begin at the end of Q4 2019. Follica’s technology and strong IP is based on work exclusively licensed from the University of Pennsylvania that has been further enhanced and protected by Follica’s internal development work.

    Forward Looking Statement
    This press release contains statements that are or may be forward-looking statements, including statements that relate to the company's future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

    Original document: http://puretechhealth.com/news/23-p...o-pivotal-study-in-male-androgenetic-alopecia
    Link: https://www.biospace.com/article/re...e-interim-data-in-male-androgenetic-alopecia/
     
    #1 itsjustsimon, Jun 13, 2019
    Last edited: Jun 13, 2019
    zinny999, kuba197, dermrafok and 4 others like this.
  2. br1

    br1 Senior Member

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    These guys never release... but hey, they have a website.
     
  3. Kagaho

    Kagaho Established Member My Regimen

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    So, they are happy with the results but still optimising.
     
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  4. Rolandconil

    Rolandconil Established Member My Regimen

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    http://www.follicabio.com/
    hey, where did the smartphone go? where is the second device? or just need to visit the doctor several times?
    or they have a bad web programmer?

    Intermediate research ... main research .., then they will say the final research blah blah blah. Well, how much can you already pull the tires .. suka blyat
     
  5. hanginginthewire

    hanginginthewire Senior Member

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    I’m progressing towards my goal of being a billionaire guys!
     
  6. MrJolly16

    MrJolly16 Experienced Member

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    So, will that be a device we can have at home? Will we have to pay a visit to a dcotor? Hope she´s hot stuff if we have to do that.
     
  7. Xaser94

    Xaser94 Established Member

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    Wow. This is great news!
     
  8. Star Trek fan

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    I assume that’s... sarcasm :(
     
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  9. Xaser94

    Xaser94 Established Member

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    No, I'm being serious. I think follica is the most feasible treatment that will come out in the near future. I'm not going to Japan for sheseido/tsuji or Mexico for histogen. My Norwood 2.5 is halted on propecia right now and if follica can help me get some density back and lower my hairline by 1 Norwood, I'll be very happy.

    Follica is using a 505b pathway.

    "505 (b)(2) may represent an appealing pathway for drug approval for manufacturers for certain products. The ability to utilize previously completed research as part of the FDA submission can save a great deal of time and money compared to the traditional full NDA."

    Chances are their pivotal trial won't take a whole year. Starting propecia was the best thing I did. Delays don't really get me down anymore since it's not a race against the clock to save my hair. Follica publicly saying they are growing new hair is a good thing. No reason for people to think this is bad.
     
  10. PeggyPeterson

    PeggyPeterson Established Member My Regimen

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    The press release seems quite underwhelming to be honest. No mnetion of the drugs they were mentioning would go with the skin disruption, so it implies that they are leaning more towards the wounding aspect.

    “Significant Therapeutic Advantage” has no scientific meaning. If the results are not statistically significant compared to other “commercially available skin disruption technology” then it’s not worth mentioning. Also...OTHER SKIN DISRUPTION TECHNOLOGY?
     
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  11. Jjmac

    Jjmac Member My Regimen

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    You bald pricks are incapable of being optimistic.
     
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  12. kiwi666

    kiwi666 Experienced Member My Regimen

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    Your momma has a website ;)
     
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  13. kiwi666

    kiwi666 Experienced Member My Regimen

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    Yeah I know right. He’s a whiny little cu_t.

    If Follica had announced they had collapsed he’d be posting “uhhhhh those guys sucked anyway.... uhhhhh I knew it.... uhhhhh duuuuuh”.
     
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  14. Pigeon

    Pigeon Senior Member My Regimen

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    Just hoping for good Shiseido news.
     
  15. Xaser94

    Xaser94 Established Member

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    "In addition to demonstrating tolerability and informing key treatment parameters, the study achieved a visible and statistically significant improvement in non-vellus (visible) hair count after three months of treatment, compared to baseline, according to an analysis of 20 study participants. "

    It's almost like you didn't even read it smh. Who cares if it's just wounding. If they can give me reliable results with just wounding idc.
     
  16. PeggyPeterson

    PeggyPeterson Established Member My Regimen

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    I did read that bit, basically it is saying wounding helps (we’ve already kind of discovered that).
    You can start wounding now! Why wait. If you don’t want to do it at home, some cosmetic clinics offer PRP + wounding.

    If you read the next paragraph, they’ve compared their wounding device to something that’s already out there (I’m guessing a dermaroller). They don’t say whether the Follica device is statistically significant, which matters, because that word can not be used carelessly as it will be deceiving investor. That’s why they used the words thereaupeutically significant -it’s just jargon.

    I want this thing to work, but I was hoping their drugs would be the main selling point.
     
    #16 PeggyPeterson, Jun 14, 2019
    Last edited: Jun 14, 2019
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  17. MrJolly16

    MrJolly16 Experienced Member

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  18. tomJ

    tomJ Experienced Member My Regimen

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    Why is it going to take approximately another 6 months to initiate the pivotal trial? I dont understand why they are moving so slow.
     
  19. Rolandconil

    Rolandconil Established Member My Regimen

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    MrJolly16 likes this.
  20. Janks16

    Janks16 Established Member My Regimen

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    It may very well work. I sure hope it does, but we're years away from seeing this come to market. A new study is starting at the end of the year. :(
     
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