Bayer Prolactin Receptor Antibody For Male And Female Pattern Hair Loss

[Roeysdomi]

Haha, I am trying to spread some positivity in this thread. Maybe youre right.
I am living in a bigger german city and I saw at least 15 people who had a hair transplant and I know one guy who had already 2 in Turkey
Even if it will not reach 100% density, no one has to be bald nowadays. Its a choice.

I am losing ground fast as f***, but at least we have options. Keep your head up, guys. In the end of the day its just hair, even if its annoying!

No one has to be bald? Tell that to the whole nw6-7 with diffused donor zone.

 

[coolio]

No one has to be bald? Tell that to the whole nw6-7 with diffused donor zone.

The usual response to that is "yOU SHOUld have GoTTen on finASTERide". As if miniaturization never starts before your 20s and as if 5ar drugs never cause hormonal side effects.

 

[Roeysdomi]

The usual response to that is "yOU SHOUld have GoTTen on finASTERide". As if miniaturization never starts before your 20s and as if 5ar drugs never cause hormonal side effects.

The drug not always keep working forever specially for aggressive balding like nw6-7

 

[JohnDoe5]

The Status of the trial is „Not yet recruiting“.

We could be happy If we hear something und end of 2023. The study completion is in March 2024 so Maybe we will get the results in Summer 2024…

These Are the Dates For the Phase I Trial:

Estimated Study Start Date :	April 2022
Estimated Primary Completion Date :	July 2023
Estimated Study Completion Date :	March 2024

There is No reason to believe we get the results earlier then it is officially announced on clinicaltrials.gov unfortunately

Could someone please explain the below information to me? The 1st link says that HMI-115 is only now preparing to go into a phase 1 trial for hair loss and recruitment hasn't even started yet BUT the 2nd link says that Hope Medicine has been given clearance to start its phase 2 trial with the same treatment and also for hair loss. Since the company was given clearance to start its' phase 2 study that should mean the phase 1 study is completed and the results have been tabulated. I'm confused. Which one of these 2 links is accurate?

ClinicalTrials.gov

clinicaltrials.gov

Hope Medicine Announces US FDA Clearance for Phase II Clinical Trial of A First-in-class Monoclonal Antibody, HMI-115, in Androgen Alopecia | BioSpace

Hope Medicine Announces US FDA Clearance for Phase II Clinical Trial of A First-in-class Monoclonal Antibody, HMI-115, in Androgen Alopecia - read this article along with other careers information, tips and advice on BioSpace

www.biospace.com

 

[pegasus2]

Could someone please explain the below information to me? The 1st link says that HMI-115 is only now preparing to go into a phase 1 trial for hair loss and recruitment hasn't even started yet BUT the 2nd link says that Hope Medicine has been given clearance to start its phase 2 trial with the same treatment and also for hair loss. Since the company was given clearance to start its' phase 2 study that should mean the phase 1 study is completed and the results have been tabulated. I'm confused. Which one of these 2 links is accurate?

ClinicalTrials.gov

clinicaltrials.gov

Hope Medicine Announces US FDA Clearance for Phase II Clinical Trial of A First-in-class Monoclonal Antibody, HMI-115, in Androgen Alopecia | BioSpace

Hope Medicine Announces US FDA Clearance for Phase II Clinical Trial of A First-in-class Monoclonal Antibody, HMI-115, in Androgen Alopecia - read this article along with other careers information, tips and advice on BioSpace

www.biospace.com

This was covered just 2 or 3 pages back in this thread. People really need to learn to read first and ask questions later

 

[Tarcko]

Even $60,000 or $80,000 is still a lot of money, especially for young people.

Yes but now i have a real motivation to make money ))

 

[-specter-]

I realize that for many this is "only" an aesthetic problem and therefore it is not given relevance. But there are many people who suffer from it on a personal level and I am sure that many who shave their heads and ignore it deep down also suffer from it. It is a question of human dignity, not just an aesthetic problem. If the investors and whoever managed it were not cynical Methuselahs, all this would be clearer. To wait decades for something that could be solved in 2-4 years is absurd.

Now we find ourselves with Australia that rejected phase 2 because Hope medicine wanted to save twice, the first time by doing phase 1 only for women, the second time when it decided to do a single joint phase two in the various countries. This ridiculous and irresponsible management of the company has led not only to delays but also to spending more money, other than saving.

 

[pegasus2]

I realize that for many this is "only" an aesthetic problem and therefore it is not given relevance. But there are many people who suffer from it on a personal level and I am sure that many who shave their heads and ignore it deep down also suffer from it. It is a question of human dignity, not just an aesthetic problem. If the investors and whoever managed it were not cynical Methuselahs, all this would be clearer. To wait decades for something that could be solved in 2-4 years is absurd.

Now we find ourselves with Australia that rejected phase 2 because Hope medicine wanted to save twice, the first time by doing phase 1 only for women, the second time when it decided to do a single joint phase two in the various countries. This ridiculous and irresponsible management of the company has led not only to delays but also to spending more money, other than saving.

That's overly pessimistic. It is normal to have a single multicenter global phase 2, and increases statistical power. As for only doing one phase 1, HMI isn't the one to blame for that. That trial was conducted by Bayer because they had no plans to use the drug for hair loss. When HMI purchased rights to the drug that changed. If they had decided to start with a phase 1 for hair loss they would still be waiting for that trial instead of having an approval to run a phase 2 in the US. Their choice will get the drug to market faster provided they move forward with the phase 2 in the US without waiting for the Australian trial to complete. No one knows what their plans are so there is no foundation to criticize them on this matter

 

[-specter-]

That's overly pessimistic. It is normal to have a single multicenter global phase 2, and increases statistical power. As for only doing one phase 1, HMI isn't the one to blame for that. That trial was conducted by Bayer because they had no plans to use the drug for hair loss. When HMI purchased rights to the drug that changed. If they had decided to start with a phase 1 for hair loss they would still be waiting for that trial instead of having an approval to run a phase 2 in the US. Their choice will get the drug to market faster provided they move forward with the phase 2 in the US without waiting for the Australian trial to complete. No one knows what their plans are so there is no foundation to criticize them on this matter

I hope you are right, and that no more time is wasted on the buttercracy

 

[JohnDoe5]

This was covered just 2 or 3 pages back in this thread. People really need to learn to read first and ask questions later

So the Aussies have been given the green light to start a phase 1 study while they have been given the green light to start a phase 2 in the US. Interesting. I suspect they'll start phase 1 in Australia while starting phase 2 in the US at the same time. Of course, I'm not sure of this but it's my suspicion.

 

[pegasus2]

So the Aussies have been given the green light to start a phase 1 study while they have been given to start a phase 2 in the US and Europe. Interesting. I suspect they'll start phase 1 in Australia while starting phase 2 in the US and Europe at the same time. Of course, I'm not sure of this but it's my suspicion.

It might make the most sense to wait three months to see if the dose used in the AUS phase I trial is working. They've probably already dosed the first patient.

 

[RolfLeeBuckler]

So the Aussies have been given the green light to start a phase 1 study while they have been given to start a phase 2 in the US and Europe. Interesting. I suspect they'll start phase 1 in Australia while starting phase 2 in the US and Europe at the same time. Of course, I'm not sure of this but it's my suspicion.

where Did you See that they have Been given a green light to start Phase II in Europe? I think only US was mentioned…

 

[JohnDoe5]

where Did you See that they have Been given a green light to start Phase II in Europe? I think only US was mentioned…

You're right. My mistake.

 

[RolfLeeBuckler]

You're right. My mistake.

Unfortunately a Mistake

 

[JohnDoe5]

Unfortunately a Mistake

At least the US has authorized the company to go ahead with phase 2. If the company starts phase 2 in the US that means 2 good things for you.

1. If a US phase 2 study proves the treatment works then you might be able to get it early via blackmarket.

2. If a US phase 2 study proves the treatment works it would move to phase 3 in the US and once it completes phase 3 you could fly to America and get the treatment and then go home. Now, if you do it this way, rather than getting it blackmarket, then you would have to stay in America for months until you've used the treatment long enough that the recovery process will continue even after you go home and stop using the treatment.

 

[RolfLeeBuckler]

At least the US has authorized the company to go ahead with phase 2. If the company starts phase 2 in the US that means 2 good things for you.

1. If a US phase 2 study proves the treatment works then you might be able to get it early via blackmarket.

2. If a US phase 2 study proves the treatment works it would move to phase 3 in the US and once it completes phase 3 you could fly to America and get the treatment and then go home. Now, if you do it this way, rather than getting it blackmarket, then you would have to stay in America for months until you've used the treatment long enough that the recovery process will continue even after you go home and stop using the treatment.

I have Zero Problem to Stay und US For months to get my hair Back.

do you think that Phase II trials will only be For US residents or will it also be possible For european People of they Stay in the US For the duration of the trial?

 

[JohnDoe5]

I have Zero Problem to Stay und US For months to get my hair Back.

do you think that Phase II trials will only be For US residents or will it also be possible For european People of they Stay in the US For the duration of the trial?

I don't know if/when US trials will take place. I've only been speculating about stuff like everyone else. That aside, I don't think that US trial managers will allow people from foreign countries to take part in US trials. IMO the people doing the trials would want to be sure that the participants live close to the study site.

When I said that you might have to reside in the USA for some months I was talking about AFTER trials are over and the treatment is on the US market you might be able to spend some time in America to get the treatment but you might have to stay in American long enough to complete the treatment regimen.

 

[Dimitri001]

At least the US has authorized the company to go ahead with phase 2. If the company starts phase 2 in the US that means 2 good things for you.

1. If a US phase 2 study proves the treatment works then you might be able to get it early via blackmarket.

2. If a US phase 2 study proves the treatment works it would move to phase 3 in the US and once it completes phase 3 you could fly to America and get the treatment and then go home. Now, if you do it this way, rather than getting it blackmarket, then you would have to stay in America for months until you've used the treatment long enough that the recovery process will continue even after you go home and stop using the treatment.

Is this plausible? Can random labs manufacture this antibody or is it too technically difficult?

 

[snake190]

Is this plausible? Can random labs manufacture this antibody or is it too technically difficult?

iirc they have contacted labs regarding HMI but were quoted an amount which was not affordable + it had to be stored in -20C

 

[Armando Jose]

iirc they have contacted labs regarding HMI but were quoted an amount which was not affordable + it had to be stored in -20C

the same conditions than actual Covid vaccine, treatment is similar