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.
Bayer Prolactin Receptor Antibody For Male And Female Pattern Hair Loss
- Thread starter Ollie
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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.
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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.
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I wrote a lot of e mails to the company and got No answers
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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.
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But in this case hope Medicine has IND Approval For Phase II studies in US. So they should move in this fuc.king Phase II Trial as planned
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The subreddit r/HairlossResearch has introduced Professor Rodney Sinclair as a resident expert (announcement). He is on the team of Sinclair Dermatology which is the outfit recruiting for the HMI trial in Australia. Perhaps we could get some info out of him. Thanks to TrichoSearch on Reddit for the tipoff!
Shouldn't even post that here, he's going to get spammed by trolls and quit reddit.
If the trial renders positive results, just hoping that the next step towards market goes through the mRNA pathway. Creating monoclonal antibodies is a expensive process, but the antibody sequence could be translated into mRNA for its production inside the body.
(https) pubmed.ncbi.nlm.nih.gov/30795778/
(https) pubmed.ncbi.nlm.nih.gov/30795778/
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So in the mRNA pathway When the product could be commercialized?
Couldn't tell really, but if the monoclonal antibody demonstrates efficacy (phase 3), then the mRNA version should undergo all the testing and trial phases since it would be a different product... Realistically, I guess that we would all be slick bald when a supposed release of an mRNA BAY/HMI-115 reached the market.
My wish concerns only money and logistics only.
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How would an mRNA approach work here? Doesn't mRNA tell cells to produce proteins? Or is an antibody a protein - pardon my ignorance.
Also, I wonder if Bayer's patent would permit someone to go down the mRNA route.
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It is all nonsense we Are discussing about. Phase 1 just started in Australia. We will hear about the results in Fall/winter of 2023 and See whether they start a Phase 2 in US in 2024.
until then we won‘t hear anything of Hope Medicine so there is Nothing to discuss unfortunately until end of 2023. See you Next Year!
until then we won‘t hear anything of Hope Medicine so there is Nothing to discuss unfortunately until end of 2023. See you Next Year!
I hope this is not the case and phase 2 starts this year. this industry is cursed or just sucks. it is impossible to think that ineffective and probably harmful vaccines have passed in a year and that for these things the fda and the financiers make so many problems.
yes of course in 25 years new things have been discovered but always only the hormonal side is targeted.
if this is long delayed, fails or has too dangerous side effects, it will be easier to imagine the end of industrial society rather than the end of baldness.
yes of course in 25 years new things have been discovered but always only the hormonal side is targeted.
if this is long delayed, fails or has too dangerous side effects, it will be easier to imagine the end of industrial society rather than the end of baldness.
The trial is already recruiting. It's only 6 months. What makes you think it will take 18 months to get results?
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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