Yea, you're right, that wasn't you. My mistake.
Bayer Prolactin Receptor Antibody For Male And Female Pattern Hair Loss
- Thread starter Ollie
- Start date
- Reaction score
- 72
I'll take it back, I shouldn't have said that. Could you please stop being so antagonistic in this thread?
Jack, I have posted a lot but I did not start the antagonism. All I did is disagree with posters who think the efficacy of hair loss treatments in macaques is the same or worse than the efficacy of the same treatments in humans. I disagree with them and I'm not going to change my opinion because I'm right.
Calling me mentally ill doesn't matter to me. I'm new to the site but I've already noticed that in virtually every thread at this site when posters disagree with each other it's just a matter of time till one of them calls the other mentally ill as if a person with mental problems is always wrong and people with mental illness should always be ignored. It's the go-to default insult here even though many of the posters here are having mental issues over hair loss.
I'm not looking for antagonism so I'm moving on from this devolving discussion. I'll find out for sure if the Bayer drug works after phase 2 study results. Good luck to all.
Last edited:
- Reaction score
- 985
The Logic of HopeMedicine:
- Getting US FDA Clearance for Phase II Clinical Trial of A First-in-class Monoclonal Antibody, HMI-115, in Androgen Alopecia (January 2022)
- HopeMedicine Plans to do „Phase II clinical trial for the treatment of androgenetic alopecia is an international multi-center, randomized, double-blind, placebo-controlled study, which is planned to be carried out in the United States, Australia and other countries.
- getting rejection For doing Phase II clinical trials in australia (Maybe in February 2022)
——->>>
april 2022: HopeMedicine Starts Phase I Trial with 20 patients in Australia
GREAT JOB!!!
- Getting US FDA Clearance for Phase II Clinical Trial of A First-in-class Monoclonal Antibody, HMI-115, in Androgen Alopecia (January 2022)
- HopeMedicine Plans to do „Phase II clinical trial for the treatment of androgenetic alopecia is an international multi-center, randomized, double-blind, placebo-controlled study, which is planned to be carried out in the United States, Australia and other countries.
- getting rejection For doing Phase II clinical trials in australia (Maybe in February 2022)
——->>>
april 2022: HopeMedicine Starts Phase I Trial with 20 patients in Australia
GREAT JOB!!!
- Reaction score
- 342
Well, but what we have right now is that minoxidil works better on macaques, for which we have pegasus' explanation, and we have the info that finasteride works better on humans. So we really have no evidence for the claim that hairloss drugs in general work better on macaques, in fact we know finasteride works better on humans, so I don't think the claim that it's easier to grow hair on macaques holds, at least based on what's been brought up in the thread so far.
- Reaction score
- 24
Hopemedicines intention was to do a international multi centre phase 2 in US/EU/AUS (I don’t know why) . But since Australia rejected them to bypass phase 1 they will have to complete phase 1 in Australia and then commence with the original plan . They must be doing it to save costs down the line. We basically got set back 1 year cause of this
- Reaction score
- 24
I feel the same way except I still have faith in MOOGENE Medi, STEMSON Tx , and dNOVO
- Reaction score
- 985
if you would like to bring HMI-115 to Market and you got a rejection in Australia and First had to do a Phase I Trial there… would you do the Phase I Trial in Australia or would you do Phase II in US and Europe to bring the product to Market as soon as possible????
it Really is to stupid For me to beliebe this fu.cking sh1t
- Reaction score
- 985
Why is f***.ing Australia that important For them??? It Makes absolutely No sense. If they did the First trial in China i would understand it because the company is pur of China. It would be mich fastet then. But Australia?! Wtf
I've been surfing baldness forums since the early 2000s. Trust me, there are always a few groups out there working on something. Multiple treatments were in development 15-20 years ago. None of it means sh*t unless they are getting results.
This prolactin receptor antibody is the most promising thing I've seen in a long time. It's also the only thing that looks promising right now. If it doesn't work then IMO we are probably staying bald until the 2030s.
Last edited:
- Reaction score
- 985
和其瑞医药首创单抗新药HMI-115治疗雄激素脱发临床二期试验申请获美国FDA批准 - 园区要闻 - 南京生物医药谷
近日，江北新区生物医药谷园区企业Hope Medicine Inc.（和其瑞医药）（以下简称“和其瑞”），一家科学驱动的临床阶段创新生物制药公司，...
www.njbpv.cn
The application for the second clinical trial of HMI-115, the first new monoclonal antibody drug, for androgen loss has been approved by the US FDA. Release Date: 2022-01-27 Views: 160 Recently,
Hope Medicine Inc., a biomedical valley company in Jiangbei New Area region ( Heqirui Pharmaceuticals (hereinafter referred to as Heqirui), a science-based clinical innovation biopharmaceutical company, announced its first new drug of monoclonal antibody HMI-115, which is of global interest and was approved by the U.S. Food and Drug Administration (FDA) for the treatment of endometriosis II in 2021. Following the Phased Trial (IND) clinical trial, her application for a Phase II clinical trial (IND) for the treatment of Androgen hair loss (Androgenetic Alopecia) also recently approved by the US FDA. In April 2019, Heqirui Pharmaceuticals and Bayer AG signed a global exclusive license agreement for the development and industrialization of HMI-115, a monoclonal antibody targeting a prolactin receptor (PRLR). It is being developed and industrialized by Heqirui Pharmaceutical to develop and industrialize a number of indications around the world. This antibody has demonstrated excellent properties in animal models including non-human primate (NHP) models and human safety. Its treatment of two major indications, endometriosis and androgen alopecia, has been approved by the US FDA for a second stage clinical trial. The second stage clinical trial of HMI-115 in endometriosis started in late 2021 in the United States. The Phase Two Clinical Trial for the Treatment of Androgen Allopecia is an international, multi-center, randomized, double-blind, placebo-controlled study to be conducted in the United States, Australia and other countries. Dr., CEO of Chery Pharmaceuticals Henri Nico Doods said: "The FDA approved the IND of the second indication of HMI-115 and I am proud of the company which is an important milestone for young startups like Heqirui. This is an important step towards our vision to bring a new drug and highly differentiated products to patients around the world Patients with two main indications of endometriosis and hair loss look forward to new treatments with better efficacy and safety To be able to receive two IND approvals in such a short time, is a great incentive for the Heqirui team.We will continue to strengthen and expand global clinical research and development activities and strive to bring more innovative drug treatment options to patients around the world.
You realize that they can still launch a P2 trial in the USA or EU right? There is no press release with this Aus trial, meaning they probably have other things ready to launch/announce before they start issuing the final press release.
- Reaction score
- 985
i Hope you Are Right. But i am very nervous… it Doesnt make Sense to start Phase I and immediately After this starting a Phase II Trial in other countries.
It would make Sense:
Option 1: to do Phase I and wait until Trial finished. After then checken the results and think about If it is Worth to start Phase II.
Option 2: to start Phase II in US directly
They are not doing a phase 1 to check if it's worth it, no one does that. Phase 1 is generally 100% safety related.
They're doing a phase 1/2 because Australia clearly declined to allow a P2 to start in their country without data for that dose level or on men at all.
- Reaction score
- 985
yes But Why they start this Australia Trial at First?
they had FDA clearance in US For Phase II Trial! Why Arent they faster in starting the Trial in US then starting in Australia?
Should email the company* and ask. Obviously Australia is an important market for them as they aren't even doing trials in China yet despite almost guaranteed clearance.
Last edited:
- Reaction score
- 985
I wrote a lot of e mails to the company and got No answers
- Reaction score
- 24
Advantages of clinical trial in Australia :
“Cost – In comparison to US and Europe, Australia is 30% lower in study budgets. If R&D tax incentives are applicable, the cost advantage climbs to over 50%.
Incentives – Australia has the highest tax incentive for medical research and clinical trials in the world. Australia offers a generous 43.5% cash refund for clinical trials conducted in Australia if the applying country has a global revenue of less than 20M AUD.
Investigational New Drug (IND) not a pre-requisite – One of the major advantages of conducting clinical trials in Australia is that there is no need for an approved US FDA IND for initiating clinical studies. Clinical studies can be initiated in Australia at any time before or during the IND application process and then the data from these studies supplemented to the application, thus leading to a tremendous advantage of saved time. We have witnessed companies advancing directly in to Phase II at the time of IND approval since all Phase I studies were completed in Australia by the time IND approval was secured. This has been possible due to confidence in the very high quality of data generated for clinical studies in Australia.