HMI-115 PRLR antibody: The Most Promising Treatment Ever

[RagnarLothbrok]

Uhmm, im asuming it means its already confirmed "for schedule". But yeah, the website graphic makes it look like they are full blown into phase 2 already wtf

 

[snake190]

Would it be possible to procure it off-label once it passes the endo trails? Because it seems endo would complete p3 before Androgenetic Alopecia. Probably 2024-2025 or something?

 

[RagnarLothbrok]

Would it be possible to procure it off-label once it passes the endo trails? Because it seems endo would complete p3 before Androgenetic Alopecia. Probably 2024-2025 or something?

Yeah, if it becomes an FDA approved drug and is commercially available usually doctors can prescribe it off-label. But this is not some cute cream you buy on pharmacy and put in your head, it is an injection of antibodies in abdomen, so maybe it's gonna be hard to convince the docs lol

 

[Redgate]

What doctor is going to prescribe an antibody, that only has an approved indication for women, to balding men that are citing a monkey study they read on a hair loss cope forum? Practically you'd have to find someone who posts here.
Also let's not forget that this is extremely expensive and probably more so for endometriosis because they'll rip off insurance (which won't cover off-label scripts)

 

[Feelsbadman.jpg]

Yeah, if it becomes an FDA approved drug and is commercially available usually doctors can prescribe it off-label. But this is not some cute cream you buy on pharmacy and put in your head, it is an injection of antibodies in abdomen, so maybe it's gonna be hard to convince the docs lol

This treatment should also be beneficial in treating metabolic syndrome to an extent. It should have health promoting effects for just about everyone I think. I would go that route, i.e. your cardiometabolic profile is at risk, rather than asking for it strictly for treatment for hair loss.

 

[pegasus2]

Yeah, if it becomes an FDA approved drug and is commercially available usually doctors can prescribe it off-label. But this is not some cute cream you buy on pharmacy and put in your head, it is an injection of antibodies in abdomen, so maybe it's gonna be hard to convince the docs lol

The chances of it getting approved for endometriosis are less than 50%, but if it does get approved you'll be able to get it off label if you're willing to pay cash. It will be 80k a year or more for endometriosis, and if the dose is only half that for Androgenetic Alopecia then you'll pay double.

 

[Feelsbadman.jpg]

The chances of it getting approved for endometriosis are less than 50%, but if it does get approved you'll be able to get it off label if you're willing to pay cash. It will be 80k a year or more for endometriosis, and if the dose is only half that for Androgenetic Alopecia then you'll pay double.

Why would you need to pay the endometriosis cost yearly? The macaque study showed regrowth/maintenance continued long after treatment stopped. The phase II endometriosis trial is only 12 weeks of administrating a dose of of HMI 115 every two weeks. You could run one course of it off label and then wait for the Androgenetic Alopecia dose and frequency of application to be released.

 

[pegasus2]

Why would you need to pay the endometriosis cost yearly? The macaque study showed regrowth/maintenance continued long after treatment stopped. The phase II endometriosis trial is only 12 weeks of administrating a dose of of HMI 115 every two weeks. You could run one course of it off label and then wait for the Androgenetic Alopecia dose and frequency of application to be released.

Hair growth in macaques didn't peak at the end of 6 months. It's likely you need to dose for at least 1 year for maximum regrowth. Additionaly, while the macaques remained well above baseline for 4 years after discontinuation they did lose significant ground 6 months after treatment was stopped. That is clear from the trichogram images. The length of the trial has nothing to do with how long the drug will be prescribed. We all know that finasteride trials were 12 months long, but the drug is for life. In the case of endometriosis the trial end point is not reversal of the disease, it is relief of symptoms. The drug will need to be taken indefinitely for endo. That doesn't really matter to us though. The point is that the cost of the endo treatment will likely work out to a minimum of $3,000 per dose. If you are prescribed the drug off label for another indication that is the price you will pay. However, if the endo dose is 120mg and the Androgenetic Alopecia dose 240mg, then you will pay $6,000 per dose. If you take the drug for one year that's $156,000.

 

[fashy]

However, if the endo dose is 120mg and the Androgenetic Alopecia dose 240mg, then you will pay $6,000 per dose. If you take the drug for one year that's $156,000.

OR, alternatively, you can buy a rope for 10$ for one-time use only. It's all you'll ever need.

 

[RagnarLothbrok]

I would pay that right now if it had proved macaque results in humans, people have different priorities u know.

I would never spend $150k in some luxury car despite having money, but I would do it on this immediatly. To each their own. Let people spend money on w/e the f they want lol

 

[Dr sanches]

Hair growth in macaques didn't peak at the end of 6 months. It's likely you need to dose for at least 1 year for maximum regrowth. Additionaly, while the macaques remained well above baseline for 4 years after discontinuation they did lose significant ground 6 months after treatment was stopped. That is clear from the trichogram images. The length of the trial has nothing to do with how long the drug will be prescribed. We all know that finasteride trials were 12 months long, but the drug is for life. In the case of endometriosis the trial end point is not reversal of the disease, it is relief of symptoms. The drug will need to be taken indefinitely for endo. That doesn't really matter to us though. The point is that the cost of the endo treatment will likely work out to a minimum of $3,000 per dose. If you are prescribed the drug off label for another indication that is the price you will pay. However, if the endo dose is 120mg and the Androgenetic Alopecia dose 240mg, then you will pay $6,000 per dose. If you take the drug for one year that's $156,000.

It only last 4 years ?

 

[pegasus2]

I would pay that right now if it had proved macaque results in humans, people have different priorities u know.

I would never spend $150k in some luxury car despite having money, but I would do it on this immediatly. To each their own. Let people spend money on w/e the f they want lol

But would you spend that knowing that you can get it for a third if the price of you wait one year?

 

[Feelsbadman.jpg]

Hair growth in macaques didn't peak at the end of 6 months. It's likely you need to dose for at least 1 year for maximum regrowth. Additionaly, while the macaques remained well above baseline for 4 years after discontinuation they did lose significant ground 6 months after treatment was stopped. That is clear from the trichogram images. The length of the trial has nothing to do with how long the drug will be prescribed. We all know that finasteride trials were 12 months long, but the drug is for life. In the case of endometriosis the trial end point is not reversal of the disease, it is relief of symptoms. The drug will need to be taken indefinitely for endo. That doesn't really matter to us though. The point is that the cost of the endo treatment will likely work out to a minimum of $3,000 per dose. If you are prescribed the drug off label for another indication that is the price you will pay. However, if the endo dose is 120mg and the Androgenetic Alopecia dose 240mg, then you will pay $6,000 per dose. If you take the drug for one year that's $156,000.

I don't think you will need injections every two weeks for life to treat endometriosis or Androgenetic Alopecia for life. Like you said, results will peak at some point and then to maintain this, the time in between treatments can be extended. The length of the trial does have something to do with the time frame that researches expect peak results to be achieved or at least approached. 12 weeks may not be enough to get maximum effect for endometriosis but it's at least long enough/enough injections to illicit a positive result. That's why the researchers chose that interval.

My point is, if you are losing hair now, you are better off getting a round of HMI 115 off label, and then waiting a few years for the more affordable Androgenetic Alopecia dose to come out then doing nothing but wait for years until the Androgenetic Alopecia dosing amount/schedule is released for prescription. You seem to be an all or nothing mindset. Taking 6 doses and then waiting a couple years to take it on a regular interval for Androgenetic Alopecia is better than doing nothing. Basically, taking what you can afford sooner is going to be better as it slows the damage of Androgenetic Alopecia sooner which should allow for better results later on when optimal dosing becomes available.

 

[Feelsbadman.jpg]

But would you spend that knowing that you can get it for a third if the price of you wait one year?

How do you know the Androgenetic Alopecia treatment will be cheaper?

Hair growth in macaques didn't peak at the end of 6 months. It's likely you need to dose for at least 1 year for maximum regrowth. Additionaly, while the macaques remained well above baseline for 4 years after discontinuation they did lose significant ground 6 months after treatment was stopped. That is clear from the trichogram images. The length of the trial has nothing to do with how long the drug will be prescribed. We all know that finasteride trials were 12 months long, but the drug is for life. In the case of endometriosis the trial end point is not reversal of the disease, it is relief of symptoms. The drug will need to be taken indefinitely for endo. That doesn't really matter to us though. The point is that the cost of the endo treatment will likely work out to a minimum of $3,000 per dose. If you are prescribed the drug off label for another indication that is the price you will pay. However, if the endo dose is 120mg and the Androgenetic Alopecia dose 240mg, then you will pay $6,000 per dose. If you take the drug for one year that's $156,000.

If this is the case, why would the Androgenetic Alopecia treatment be cheaper, especially since it will be considered cosmetic? I hope it is but am just curious what the basis for us assuming it will be is.

 

[pegasus2]

I don't think you will need injections every two weeks for life to treat endometriosis or Androgenetic Alopecia for life. Like you said, results will peak at some point and then to maintain this, the time in between treatments can be extended. The length of the trial does have something to do with the time frame that researches expect peak results to be achieved or at least approached. 12 weeks may not be enough to get maximum effect for endometriosis but it's at least long enough/enough injections to illicit a positive result. That's why the researchers chose that interval.

My point is, if you are losing hair now, you are better off getting a round of HMI 115 off label, and then waiting a few years for the more affordable Androgenetic Alopecia dose to come out then doing nothing but wait for years until the Androgenetic Alopecia dosing amount/schedule is released for prescription. You seem to be an all or nothing mindset. Taking 6 doses and then waiting a couple years to take it on a regular interval for Androgenetic Alopecia is better than doing nothing. Basically, taking what you can afford sooner is going to be better as it slows the damage of Androgenetic Alopecia sooner which should allow for better results later on when optimal dosing becomes available.

There's a big difference between Androgenetic Alopecia and endometriosis. HMI-115 apparently reverses Androgenetic Alopecia. It only eases the pain of endometriosis. It's laughable to think 12 weeks of injections will cute endometriosis. Clinical trials are expensive. The length of a trial is chosen based on how long it is expected before clinical benefit and safety can be assessed. It doesn't have to be maximum benefit, especially in a phase 2. For example, the phase 2 trials for minoxidil and finasteride were 6 months, whereas phase 3 was 12 months. You can't just take finasteride or minoxidil for 12 months and then stop. You have to stay on them for life.

I didn't say you will need injections for life with Androgenetic Alopecia, but you will work endo. With Androgenetic Alopecia you may need a course of injections every few years, or perhaps you can maintain with dutasteride. You glossed over the fact that reversal of hair loss with HMI is NOT permanent. There is significant regression 6 months after treatment is stopped.

I guess if you're a billionaire you might not be worried about spending an extra 100k. I'm a millionaire and very much want my hair back, but I wouldn't throw away 100k like that instead of waiting one year. Taking it for 12 weeks is not going to make much difference. You need 6 months to get good results if you are a top responder. Likely you need a year if you are the average lab monkey

 

[pegasus2]

How do you know the Androgenetic Alopecia treatment will be cheaper?

If this is the case, why would the Androgenetic Alopecia treatment be cheaper, especially since it will be considered cosmetic? I hope it is but am just curious what the basis for us assuming it will be is.

The only dose being trialed for Androgenetic Alopecia is 240mg. The doses being trialed for endo are 60, 120, and 240mg. I don't know what final dose will be, but there's a very good chance that the dose for Androgenetic Alopecia will be twice as high as the dose for endo. That means that even if the two treatments will be marketed for the same price it will be twice as expensive to buy 240mg of the endo drug. This is similar to clascoterone. The dose for acne is about 7.5x less than the dose for Androgenetic Alopecia, so if you want it off label for Androgenetic Alopecia it costs 7.5x as much.

This is going to be the first monoclonal antibody not covered by insurance. There is no precedent, but it stands to reason that it will be cheaper if they want people to pay it. Not a lot of people are going to be able to cough up the 80k average annual price of an mAb. Insurance won't cover it so the cost will have to be somewhat lower.

 

[waynakyo]

So the idea of a lab doing something for us here, a GB type of deal is out of the question and why?

 

[Feelsbadman.jpg]

There's a big difference between Androgenetic Alopecia and endometriosis. HMI-115 apparently reverses Androgenetic Alopecia. It only eases the pain of endometriosis. It's laughable to think 12 weeks of injections will cute endometriosis. Clinical trials are expensive. The length of a trial is chosen based on how long it is expected before clinical benefit and safety can be assessed. It doesn't have to be maximum benefit, especially in a phase 2. For example, the phase 2 trials for minoxidil and finasteride were 6 months, whereas phase 3 was 12 months. You can't just take finasteride or minoxidil for 12 months and then stop. You have to stay on them for life.

I didn't say you will need injections for life with Androgenetic Alopecia, but you will work endo. With Androgenetic Alopecia you may need a course of injections every few years, or perhaps you can maintain with dutasteride. You glossed over the fact that reversal of hair loss with HMI is NOT permanent. There is significant regression 6 months after treatment is stopped.

I guess if you're a billionaire you might not be worried about spending an extra 100k. I'm a millionaire and very much want my hair back, but I wouldn't throw away 100k like that instead of waiting one year. Taking it for 12 weeks is not going to make much difference. You need 6 months to get good results if you are a top responder. Likely you need a year if you are the average lab monkey

I don't think I did. Are you implying that HMI 115 is purely a growth stimulant that doesn't disrupt the Androgenetic Alopecia process in a manner that provides long term maintenance above baseline? Because that is what the macaque study shows.

 

[Feelsbadman.jpg]

The only dose being trialed for Androgenetic Alopecia is 240mg. The doses being trialed for endo are 60, 120, and 240mg. I don't know what final dose will be, but there's a very good chance that the dose for Androgenetic Alopecia will be twice as high as the dose for endo. That means that even if the two treatments will be marketed for the same price it will be twice as expensive to buy 240mg of the endo drug. This is similar to clascoterone. The dose for acne is about 7.5x less than the dose for Androgenetic Alopecia, so if you want it off label for Androgenetic Alopecia it costs 7.5x as much.

This is going to be the first monoclonal antibody not covered by insurance. There is no precedent, but it stands to reason that it will be cheaper if they want people to pay it. Not a lot of people are going to be able to cough up the 80k average annual price of an mAb. Insurance won't cover it so the cost will have to be somewhat lower.

So using the lesser dose would have 0 impact in slowing the progression of Androgenetic Alopecia? Again, you are all or nothing here.

 

[pegasus2]

I don't think I did. Are you implying that HMI 115 is purely a growth stimulant that doesn't disrupt the Androgenetic Alopecia process in a manner that provides long term maintenance above baseline? Because that is what the macaque study shows.

I'm saying that it's in-between. It doesn't make your hair magically immune to Androgenetic Alopecia. The macaque study shows a rather large decline in hair shaft diameter at 6 months without treatment.