Cassiopea Announces Very Positive Phase 2 Twelve Months Results For Breezula

[hypetraintime]

http://www.cassiopea.com/news-and-media/press-releases/yr-2019/190416.aspx

It's happening.

12 Month Efficacy Results

Compared to the 6 Month Efficacy Results

 

[inmyhead]

Are they in phase 3 already?

 

[baldman329]

Woh, this is big news.... looks like there's finally an alternative to minoxidil soon

 

[hypetraintime]

Are they in phase 3 already?

"Diana Harbort, CEO of Cassiopea, said: “We are very pleased by these excellent results which show that our topical anti-androgen is efficacious in the treatment of Androgenetic Alopecia with side effects similar to placebo and importantly without any systemic side effects. Based on these results, we plan to meet with the FDA mid-year to discuss the planned six-month Phase III trials in men. Hopefully, we will begin our Phase III program in 4Q 2019."

It's interesting that they are only planning a 6 month phase 3. They must be confident it works.

 

[hailbrotzu]

Time to buy some CB

 

[inmyhead]

"Diana Harbort, CEO of Cassiopea, said: “We are very pleased by these excellent results which show that our topical anti-androgen is efficacious in the treatment of Androgenetic Alopecia with side effects similar to placebo and importantly without any systemic side effects. Based on these results, we plan to meet with the FDA mid-year to discuss the planned six-month Phase III trials in men. Hopefully, we will begin our Phase III program in 4Q 2019."

It's interesting that they are only planning a 6 month phase 3. They must be confident it works.

So probably 2021 release date at the best, 2022 most likely.

 

[Iah11]

surely this data disproves everyone saying winlevi will be useless for hair loss? the dose response curve does not seem very steep. the 2.5% BD group outperformed 5% BD and 7.5% QD.

 

[Tom4362]

So how does it compare to finasteride?

 

[MrJolly16]

So, is it better than minoxidil and finasteride then? Her CEO rocks, but he it to hit market as soon as possible!

 

[Iah11]

"Diana Harbort, CEO of Cassiopea, said: “We are very pleased by these excellent results which show that our topical anti-androgen is efficacious in the treatment of Androgenetic Alopecia with side effects similar to placebo and importantly without any systemic side effects. Based on these results, we plan to meet with the FDA mid-year to discuss the planned six-month Phase III trials in men. Hopefully, we will begin our Phase III program in 4Q 2019."

It's interesting that they are only planning a 6 month phase 3. They must be confident it works.

if you compare 12 month efficacy data to the 6 month efficacy data, it seems that results are better at 6 months. Does this mean that tolerance develops to this medication like minoxidil? hard to say yet, but something to keep in mind.

EDIT: anecdotal evidence from some online experimenters is that it has worked for them for numerous years, but we won't know for real until/if it is released

 

[Ryko]

Finally, here's for hoping it will be available in 2022. Guess, gonna have to stretch finasteride for 3 years.

 

[alibaba92]

@petersonKj

 

[hypetraintime]

the 2.5% BD group outperformed 5% BD and 7.5% QD

It only outperformed in the patient questionnaire. Winlevi 1% won't be useless, but it definitely won't outperform Breezula 2.5%. Also considering it's an oil-in-water (O/W) emulsion, it may be difficult to apply to the scalp.

 

[Iah11]

Just to add to my previous post, the 5% group actually kept on improving until the 12 month mark, unlike the others. Also, the groups outside of the 7.5% BD didn't change TAHC significantly from 6 to 12 months. That is odd to me. Interpreting these results, i have some questions:

1) Did patients adhere strictly to protocol (Impossible to know). I have been part of a clinical trial for a topical. I know how easy it is to skip applications by accident. The variable, seemingly random differences between the groups TAHC from 6 to 12 months, indicates that this could be a possibility.
2) How precise was the process of counting the hairs?
3) is there a dose response curve publicly available for this drug?

 

[Iah11]

It only outperformed in the patient questionnaire. Winlevi 1% won't be useless, but it definitely won't outperform Breezula 2.5%. Also considering it's an oil-in-water (O/W) emulsion, it may be difficult to apply to the scalp.

sorry, i was looking at the 6 month efficacy data. You're right.

 

[Ryko]

these are terrible results, I could not even think it wa this bad. it's over now, finasteride or shave

I don't understand how this is "terrible results", obviously even after 12 months there is still a 14.3 increase @ 7.5% Breezula with NO systemic side effects reported or observed. Now even if this is half as good as finasteride, it's still a good option to take before jumping on finasteride. Maybe some people could maintain for a long time before needing an oral AA. What did you expect, a miracle drug? The only thing that can be called a miracle is Tsuji and hair cloning which is still under development. I seriously think the reason people here are balding is because they are bitter and pessimistic as f*ck.

 

[kiwipilu]

it's only half as good as finasteirde and probably even worse since it seems to have reached maximum efficiency after 6 months and then went downhill very quickly.

both metrics are extremely bad, hair count is a joke, an actual joke and self assessment is unlike with finasteride even worse after 6 month vs 12. the placebo group barely lost any hair so this makes the results even worse

bottom line, we are fucked no, nothing can safe us

sorry but where do you see it went downhill? They actually had 2 groups using 7,5% One applied once a day(QD) and the other twice a day(BID).it looks like BID is more effective obviously.

 

[hypetraintime]

it's only half as good as finasteirde

I agree that these results are bizarre, given the drop from 20.8 to 14.3 from month 6 to 12. However, compared to Finasteride at 12 months, the results indicate that Breezula is about 70% as effective (20.1 vs 14.3). I think that this is encouraging, especially when only 2 topical applications per day is 70% as effective as finasteride (which is present in the body all day). I wouldn't be surprised if more applications per day close the gap even more.

No sure what Finasteride was at 6 months, so it's assumed linear. Also if we were never given 6 month results, this is how they compare.

 

[hypetraintime]

These are great results if this is truly whitout side effects...which I doubt though

I don't think there will be side effects (if any) similar to finasteride. However, I found a trial Cassiopea ran back in September 2018 that may suggest something. A Study to Investigate the Effects of Cortexolone 17α-propionate (and Its Metabolites) on Healthy Volunteers' Heart.

However, in their press statement, they may have addressed the results of this particular study.

'Since the chemical structure of Clascoterone is similar to that of a steroid while its function is not, cortisol levels were tested in a sub-group of patients to verify that Clascoterone is free from systemic steroid activity. The mean absolute changes of cortisol values throughout the study were similar among groups, proving that Clascoterone has no systemic effect on cortisol.'.

 

[Bigbone]

Kind of disappointing that it seems to be losing efficiency already after 6 months, however as long as it does something I still consider it a win.