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 timeClearly 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)
It seems they are more interested in pursuing Androgenetic Alopecia than you thoughtFor 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)
Yes, we should find out over the next year or two whether my speculation about their business plan is wrong...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
the status of the endo trial is "Not yet recruiting".
It just hasn't been updated.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.
I always thought they were pursuing Androgenetic Alopecia, as well as endo (whose trial has actually started)It seems they are more interested in pursuing Androgenetic Alopecia than you thought
it's kind of a meta-discussion, but this is absolutely not how early stage VC funding works.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.
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.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
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.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