Puretech Health - 2017 Annual Report (2018-04-16)
- Thread starter Noisette
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Phase 3 is set to begin following their optimization study which we know they already started and may have completed by now.
The phase 3 is just for the office device; they're already done the other things. So it won't take long.
2 years ago, they had stated a 2018 release was their target, but they did suffer about a six month setback after stating that. So 2019 sometime is a good bet.
The phase 3 is just for the office device; they're already done the other things. So it won't take long.
2 years ago, they had stated a 2018 release was their target, but they did suffer about a six month setback after stating that. So 2019 sometime is a good bet.
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- Phase 3 involves 1000-3000 patients in clinics and hospitals who are monitored carefully to determine effectiveness and identify adverse reactions. (about 3 years)
From https://www.drugs.com/fda-approval-process.html
This is the norm but the FDA offers possibilties to speed up the process.
Fast Track (I can t imagine they got this)
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.
Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.
Priority Review
Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. In 1992, under the Prescription Drug User Act (PDUFA), FDA agreed to specific goals for improving the drug review time and created a two-tiered system of review times – Standard Review and Priority Review. A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review).
A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
Significant improvement may be demonstrated by the following examples:
- evidence of increased effectiveness in treatment, prevention, or diagnosis of condition;
- elimination or substantial reduction of a treatment-limiting drug reaction;
- documented enhancement of patient compliance that is expected to lead to an improvement in serious outcomes; or
- evidence of safety and effectiveness in a new subpopulation.
From: https://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm
Since they are confident about a quick release after starting phase 3 trials they need to have some kind of boost for the FDA process.
I don't know if I'm right, but I read somewhere that medical devices have less strict requirements for Phase 3.
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Does this device need a three year Phase 3 trial?? Does it fall under the definition of “drugs”?
I don’t know the fine print of the law, but it seems odd.
In any case, it’s great to know that Follica is geared up for Phase 3
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I have not been following Follica. I guess I’m about to join this hype train now.
Is that 56% the efficacy or something else??
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If this gets commercialized, where will it first be available at?
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I was not aware that it is just about the device. Because in my understanding medical devices do not go through 3 phases for FDA approval (I thought 3Phases automatically means Drugs)
Devices are classified into 3 groups by the FDA: Class I or “low risk of illness or injury” (e.g., surgical gauze [9]); Class II or “moderate risk” (e.g., suture [10]); and Class III, those which “support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential, unreasonable risk of illness or injury” (e.g., pacemakers [11]). Class I and II devices are subject to less stringent regulatory processes than Class III devices are; Class I or II device approvals are focused on registration, manufacturing, and labeling and often do not require extensive pre-clinical or clinical data. Class III devices that have only minor differences from already approved, so-called predicate devices, may be reclassified as Class I or II and are also subject to less stringent testing requirements than most Class III devices that are without predicates.
The skin disruption should be a class I device. Since the deepth of the wounding is controlled and through microneedling it is allready known to be save.
Around three-fourths of Class I devices, and a small percentage of class II devices qualify for “exempt” status, meaning there is no need for proof of safety or efficacy, nor for clinical trials (12). They also do not need to undergo the standard pre-market notification (PMN) process. Most Class II devices, however, have to demonstrate that they will perform as expected and will have to go through a PMN (aka 501[k]) clearance, which will likely not require stringent clinical evidence.
So chances are high that the device from follica does not even need an approval trial. And definetly not a 3 phase trail.
@That Guy where is that information from
Because like I quoted from https://www.sciencedirect.com/science/article/pii/S2452302X16300183 phase 3 is not something a device has to pass. If a device needs approval the terms are Level I and II clinical evidence.
USA. However, Follica had several European trials, so it may not take long until it is avaible in Europe after American launch.
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Thank you! Unfortunately, I live in southeast Asia
Thank You Elector.................nice to have that confirmation!
With respect to time line, Puretech had previously projected that the pivotal study would begin in the first half of 2018 before they changed the language on their website to say "following the completion of the optimization study". If it is correct that the modification of the pipeline trial phase chart indicates the completion of the optimization study, I think it is reasonable to assume that the start of the pivotal trial is imminent. The other thing to keep in mind is that in 2016 (http://puretechhealth.com/images/investors/20160406-PRTC-Annual-Results-RNS.pdf), on page 24-25, Puretech stated that "Follica plans to initiate a registration study in the second half of 2016, with data read-out in 2017. If the data are favourable, Follica would potentially plan to seek FDA clearance in 2017, with commercial release to follow as soon as 2018." This statement would indicate that Puretech anticipates a rather quick FDA approval process, perhaps because they are working with compounds that have already been approved by the FDA. Of course, things could have changed since they made that statement in April 7, 2016 and the optimization study could have been testing completely different compounds. All we can do is speculate about an approval date but the good news is that if in deed they are moving to phase 3, which it appears they are, then it would seem the optimization study was not a failure and produced enough of a positive result to warrant moving forward.
If we go by the Jefferies 2017 chart that Noisette posted on p.7, this could be out by this time next year (assuming the pivotal trial starts immediately after the optimization study). If the red arrows on the chart are somewhat precise, they had the pivotal trial beginning a little after Q1 started and possible FDA clearance before the end of Q4 (so maybe 9-10 months total).
Noisette
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I'm pretty confident that Follica's treatment will be a game-changer (even more with SM and Shiseido) . It's not a cure for sure, but in their patents, they talked about the devices which can induce hair follicle neogenesis, and can also stimulate, activate, and reorganize follicular structures in order to promote hair growth. So, we can have 25% of new hair follicles (follicle neogenesis) and also new terminal hair follicles
As we can have new hairs in our donor area, we can also have new hair graft for those who have high norwoods.
It's for a device , You can see in the following sreenshot
And Puretech health expect to have a quick FDA clearance. Phase 3 could begin in few weeks, this year.56% means that Puretech health owns more than 50% of a company's outstanding shares (= Affiliate / Ownership) .
An affiliate is used to describe a parent company that possesses a minority share of ownership in a company (Follica is an affiliate of Puretech Health).
Yes exactly, as we can see in this pic
I'm also wondering this. From the brief amount I've read about this it doesn't seem like there's an anti androgen component to this so how would this be any different from a minoxidil on steroids? Then again I might be wrong and there's some sort of anti androgen component to this
Noisette
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According to their latest patent (yes
)and I think they are spending more than a decade in trials, studies, researches to test some compounds, not just a minoxidil on steroids
In this one we can read that : Needling device and Drug applicator (At-Home device)
Source: https://patents.google.com/patent/WO2017054009A1/en?oq=WO2017054009A1
[000286] In some embodiments, the hair growth-promoting agent treatment comprises treatment with one or more prostaglandin F2a analogs, prostaglandin analogs, or prostaglandins. Non-limiting examples of prostaglandin F2a analogs include bimatoprost
[000285] In some embodiments, the hair growth-promoting agent treatment comprises treatment with one or more antiandrogens, such as, e.g., finasteride (e.g., marketed as Propecia or Proscar), ketoconazole, fluconazole, spironolactone, flutamide, diazoxide, 17-alpha- hydroxyprogesterone, 11-alpha-hydroxyprogesterone, ketoconazole, RU58841, dutasteride (marketed as Avodart), fluridil, or QLT-7704, an antiandrogen oligonucleotide, or others described in Poulos & Mirmirani, 2005, Expert Opin. Investig. Drugs 14: 177-184, the contents of which is incorporated herein by reference.
[000291] In some embodiments, the hair growth-promoting agent treatment comprises treatment with a compound that mobilizes bone marrow-derived stem cells (e.g., growth factors such as G-CSF and/or chemical agents such as plerixafor (Mozobil®));
[000293] In some embodiments, the hair growth-promoting agent treatment comprises treatment with one or more agents that induce an immune response or cause inflammation, such as, e.g., tetanus toxoid, topical non-specific irritants (anthralin), or sensitizers (squaric acid dibutyl ester [SADBE] and diphenyl cyclopropenone [DPCP])
000296] In certain embodiments, a hair growth-promoting agent described herein may be used at a dosage or in a range of dosages known in the art for that agent (e.g., as made available on a package insert or in the Physicians' Desk Reference). In other embodiments the regular dosage of the hair growth-promoting agent is adjusted to optimize a combination treatment (e.g., integumental perturbation or treatment with another active ingredient) described herein. For example, the regular dosage may be increased or decreased as directed by the physician. For example, a lower dosage may be used over a shorter duration owing to the synergistic effect of combination with another treatment described herein.
According to their latest patent (yes
and I think they are spending more than a decade in trials, studies, researches to test some compounds, not just a minoxidil on steroids
In this one we can read that : Needling device and Drug applicator (At-Home device)
Source: https://patents.google.com/patent/WO2017054009A1/en?oq=WO2017054009A1
[000286] In some embodiments, the hair growth-promoting agent treatment comprises treatment with one or more prostaglandin F2a analogs, prostaglandin analogs, or prostaglandins. Non-limiting examples of prostaglandin F2a analogs include bimatoprost
[000285] In some embodiments, the hair growth-promoting agent treatment comprises treatment with one or more antiandrogens, such as, e.g., finasteride (e.g., marketed as Propecia or Proscar), ketoconazole, fluconazole, spironolactone, flutamide, diazoxide, 17-alpha- hydroxyprogesterone, 11-alpha-hydroxyprogesterone, ketoconazole, RU58841, dutasteride (marketed as Avodart), fluridil, or QLT-7704, an antiandrogen oligonucleotide, or others described in Poulos & Mirmirani, 2005, Expert Opin. Investig. Drugs 14: 177-184, the contents of which is incorporated herein by reference.
[000291] In some embodiments, the hair growth-promoting agent treatment comprises treatment with a compound that mobilizes bone marrow-derived stem cells (e.g., growth factors such as G-CSF and/or chemical agents such as plerixafor (Mozobil®));
[000293] In some embodiments, the hair growth-promoting agent treatment comprises treatment with one or more agents that induce an immune response or cause inflammation, such as, e.g., tetanus toxoid, topical non-specific irritants (anthralin), or sensitizers (squaric acid dibutyl ester [SADBE] and diphenyl cyclopropenone [DPCP])
000296] In certain embodiments, a hair growth-promoting agent described herein may be used at a dosage or in a range of dosages known in the art for that agent (e.g., as made available on a package insert or in the Physicians' Desk Reference). In other embodiments the regular dosage of the hair growth-promoting agent is adjusted to optimize a combination treatment (e.g., integumental perturbation or treatment with another active ingredient) described herein. For example, the regular dosage may be increased or decreased as directed by the physician. For example, a lower dosage may be used over a shorter duration owing to the synergistic effect of combination with another treatment described herein.
That sounds great. Now I'm just wondering about side effects from anti-androgens if you're one of the unlucky few like me who does get sides from finasteride. I wonder how they're going to address that issue