Bayer Prolactin Receptor Antibody For Male And Female Pattern Hair Loss

[Nehel]

If humor allows you to deny reality, good for you, stay in your denial my baldies.

 

[pegasus2]

If humor allows you to deny reality, good for you, stay in your denial my baldies.

I am certain it won't cost more than what I can afford. For everyone else, maybe dNovo in ten years will be cheap.

 

[Nehel]

Maybe, but that's probably not the case for the majority here.

 

[Dimitri001]

Damn, some of you lucky Yanks might get the treatment for free! I hope someone can get in, so we can have an informant.

 

[pegasus2]

Clearly the better business case can be made for running an endo phase II trial, using those results to get more funding, and then running trials for hair loss or other indications with a safety net such that the whole company doesn't fail from one bad outcome.

Biotech moves really slow, nothing unusual in the timeline of events so far. Even large pharma companies usually prioritize a single indication when pushing a drug until at least phase III, and that's with vastly more resources and experience than this company has.

(and that's all without knowing what's actually happening behind the scenes - it's still not clear if regulatory bodies will force them to do a phase I in men or let them do some kind of combined phase I/II)

You might want to email this to Henri Doods so he knows he's making a terrible mistake pursuing Androgenetic Alopecia and endo at the same time

 

[pegasus2]

For all intents and purposes in the context we care about here, this drug is still preclinical - we could literally have a human on Mars before this is available

so even though it's exciting...it might be smarter to manage your expectations about any single treatment vs being excited about the dozens of other preclinical treatments that could pay off

Here's some wild speculation (since that's the theme of the thread):

It could be the case that their relatively faster progress on phase I/II trials in women only signals that they're looking at it their product development much more sequentially than is being hoped here

ie get it near the end of phase III for endometriosis first, and only then move forward seriously on phase II for Androgenetic Alopecia

If there's obvious progress on the Androgenetic Alopecia side in a couple years, then I'm wrong about that (e.g. they're past the phase II subject recruitment stage)

this pattern would also be very similar to how finasteride itself was developed - despite knowing 100% it would also work for Androgenetic Alopecia, they waited until it was approved and in use for the prostate (and their investment recouped) before moving forward to get it approved for that 2nd indication (5 full years extra)

It seems they are more interested in pursuing Androgenetic Alopecia than you thought

 

[hmmmmmmmm]

You might want to email this to Henri Doods so he knows he's making a terrible mistake pursuing Androgenetic Alopecia and endo at the same time

Yes, we should find out over the next year or two whether my speculation about their business plan is wrong...

If they concurrently run both trials without waiting for more funding from positive endo trial results

Either way, positive news. Will be interesting to see how the trial is structured when it gets registered for recruitment

 

[Baldingtooyoung]

This was the insane expensive drug right?

 

[John Difool]

Any pointer for Australia?

 

[pegasus2]

Any pointer for Australia?

Search of: Hmi-115 | Recruiting, Not yet recruiting Studies - List Results - ClinicalTrials.gov

www.clinicaltrials.gov

 

[RolfLeeBuckler]

Search of: Hmi-115 | Recruiting, Not yet recruiting Studies - List Results - ClinicalTrials.gov

www.clinicaltrials.gov

the status of the endo trial is "Not yet recruiting".
So can we assume that they didnt even started recruiting for this trial?
I checked the "Tidewater Clinical Research" and under Endometriosis - tidewaterclinresearch.com they have a clinical trial with Endo. I think this is the trial of HopeMedecine - dont you think so?

It seems like they didnt updated the clinicaltrials.gov site.

 

[pegasus2]

the status of the endo trial is "Not yet recruiting".
So can we assume that they didnt even started recruiting for this trial?
I checked the "Tidewater Clinical Research" and under Endometriosis - tidewaterclinresearch.com they have a clinical trial with Endo. I think this is the trial of HopeMedecine - dont you think so?

It seems like they didnt updated the clinicaltrials.gov site.

It just hasn't been updated.

 

[hmmmmmmmm]

It seems they are more interested in pursuing Androgenetic Alopecia than you thought

I always thought they were pursuing Androgenetic Alopecia, as well as endo (whose trial has actually started)

No need to lie about my position in virtually every comment, we'll both find out if it's the cure at the exact same time...
regardless of any predictions made

 

[hmmmmmmmm]

an IND literally just requires the investigator to file a status report once a year, and only becomes inactive if they don't start recruiting for a trial within 2.

Even after 2 years an extension can simply be filed to keep it active https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.45

An IND was a given, unless you thought they had completely abandoned pursuing Androgenetic Alopecia (which I didn't)
Nothing has really been clarified on their business plan or timeline

 

[hmmmmmmmm]

The first piece of real info on their timeline will come when we see their registered study design, and then when recruitment for it starts.

I think (hope) we'll see that this year too, but it's not a given

And we don't even know the details of their IND - there are possibilities like it being approved for FPHL only, or the FDA requiring a combined phase I/II to be allowed to test in men. We don't have any of the details

They could still easily do what I suggested and finish their phase II endo trial to attract more funding, before starting any trial for hair loss...or not

 

[Will Be an Egg in 5 years]

So, should I be hyped up or not?

 

[hmmmmmmmm]

Our resident statistician tells us that the odds of the macaque results translating to humans is less than 1%. Clearly sophisticated investors think the chance is a great deal higher than that, as those are not odds they would take. Perhaps if they had a Canadian statistician they would make better investments.

it's kind of a meta-discussion, but this is absolutely not how early stage VC funding works.

a typical split would be a VC firm investing in 10 companies - with the expectation that 7 fail, 2 have moderate returns, 1 has good returns

failure is actually the default expectation for any specific company (despite due diligence to try to reduce this rate)...but the ones that show returns make up for all the failed bets

*(glancing at the firms that invested here, it looks like they have a 10-15% exit rate with a bunch more companies "in flight", completely in line with the principle outlined above)

Their investors could easily believe all of the following at the same time, they are not contradictory:
-Hope Medicine as a company has a better than even chance of failure at everything
-HMI has a good *enough chance of reaching the market to treat endo, making 60M a good investment to own a large share of the returns (this is actually a below average amount for recent biotech series B funding)
-HMI has a 1% chance of having the literal cure for hair loss and reaching the market in the near future

 

[trialAcc]

an IND literally just requires the investigator to file a status report once a year, and only becomes inactive if they don't start recruiting for a trial within 2.

Even after 2 years an extension can simply be filed to keep it active https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.45

An IND was a given, unless you thought they had completely abandoned pursuing Androgenetic Alopecia (which I didn't)
Nothing has really been clarified on their business plan or timeline

Sure it has...they said they planned to start the trial last year. Based on what just occurred, it's pretty damn clear that it took the FDA longer to approve this trial then the endo one. The trial will launch on the site within a few weeks and they will start recruiting this spring.

You just keep moving the goal posts over there.

 

[trialAcc]

it's kind of a meta-discussion, but this is absolutely not how early stage VC funding works.

a typical split would be a VC firm investing in 10 companies - with the expectation that 7 fail, 2 have moderate returns, 1 has good returns

failure is actually the default expectation for any specific company (despite due diligence to try to reduce this rate)...but the ones that show returns make up for all the failed bets

*(glancing at the firms that invested here, it looks like they have a 10-15% exit rate with a bunch more companies "in flight", completely in line with the principle outlined above)

Their investors could easily believe all of the following at the same time, they are not contradictory:
-Hope Medicine as a company has a better than even chance of failure at everything
-HMI has a good *enough chance of reaching the market to treat endo, making 60M a good investment to own a large share of the returns (this is actually a below average amount for recent biotech series B funding)
-HMI has a 1% chance of having the literal cure for hair loss and reaching the market in the near future

While you are not wrong about the VC structure, you are being incredibly misleading about the average biotech funding round. That average number includes companies in areas like cancer, rare and orphan disease space, etc. In the hairloss space, this is (I think) the largest funding round ever raised where hairloss is one of the primary indications. There might be a series C or D from like 2 decades ago that I'm not aware of though.

Your 50% and 1% figures are also laughably dumb. Once a drug has reached phase 2, it's odds for reaching the market are about 50%. With two indications in phase 2, the company has an above 50% chance based on historical averages for having one successful application.

 

[hmmmmmmmm]

IMO the bigger takeaway here is they're moving at a really fast pace for a biotech startup, with their endo phase II trial already recruiting before EOY 2021

a promising signal they'll also be able to move faster towards testing it for Androgenetic Alopecia (regardless of the specifics of their business strategy)

the celebration and focus on some bureaucratic paperwork is a just reflection of how starved the hair loss community always is for information outside of press releases

nuance is dead