Cassiopea Anounces Positive Breezula 12 Month Results
Today, Cassiopea SpA has announced topline data from its fully completed phase 2 dose ranging trial for men with androgenic alopecia. The results of the trial were favorable.
Phase 2 Trial for Clascoterone
The trial which was completed by Cassiopea included 400 men and 4 different doses of clascoterone, also known as breezula, for the treatment of androgenic alopecia. The different doses included 2.5%, 5.0%, 7.5% solutions twice daily and a 7.5% solution once daily. There were also subjects who received only a vehicle or placebo solution, but all subjects received applications over a 12 month period. The primary endpoints that Cassiopea were observing in the trial were 1) terminal (thick) hair count and 2) something known as a hair growth assessment score.
Efficacy Results
The best performing group of the trial were the men who received the highest dose of 7.5% solution twice daily. This is a positive indication for the breezula drug because it shows that taking more of the drug causes more of the positive hair growth effect, also known as a “dose response.” Here are some highlighted details from the press release for Cassiopea’s phase 2 dose ranging trial at 12 months:
- The average improvement in target area hair count compared to placebo group was 10.2 hairs in the 2.5% solution group, 13.8 hairs in the 5% solution group, 14.3 hairs in the 7.5% solution group (all twice daily), and 12.7 hairs in the 7.5% solution once daily group.
- In the HGA hair growth assessment, patients expressed their own personal opinion of whether their hair looked better over the 12 months of treatment. More subjects in the 4 breezula dose groups responded positively to the assessment compared to placebo.
- TAHW, or target area hair width, improved in all groups of men who received breezula applications over 12 months.
- Breezula/Clascoterone had an excellent safety profile in the trial and was similar to placebo in both adverse events and local skin reactions. The drug is also showed no systemic effect on cortisol.
- Breezula/Clascoterone is a topical anti-androgen similar to that of finasteride, however it has not shown any hormonal or sexual related side effects during its testing.
Next Steps For Men and Women
This is where we get to the ever present question in the online hair seeking world: when will this be available for me to use? Here’s a quote from CEO of Cassiopea, Diana Harbort, from the press release to address things like phase 3 trials and when women will be tested with Breezula:
“We are very pleased by these excellent results which show that our topical anti-androgen is efficacious in the treatment of AGA 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. We also plan to begin – as soon as practicable – a POC study in women, which would enlarge significantly the potential of the product. The global hair loss market is very large and very underserved with only OTC products and generic therapies available, therefore this product, if approved, could serve a global audience.”
It would be logical that if and when this product is approved for use by men much sooner than women, that it would also be available prescribed “off-label” for women as well. Also, if approved it would be the first new approved drug for hair loss/growth since finasteride in 1997. With positive results coming in from a full-fledged clinical trial, Breezula appears to be something to feel good about.
Posted in Breezula, Hair Growth Treatment
There was a decrease in the amount of hairs between month 6 to month 12…
where did you find this information?
You can look at their interim analysis (6 months) and final results (12 months):
https://www.cassiopea.com/2018/07/16/cassiopea-announces-very-positive-interim-analysis-phase-2-results-for-breezula-clascoterone-in-treating-androgenetic-alopecia/
https://www.cassiopea.com/2019/04/16/cassiopea-announces-very-positive-phase-ii-twelve-months-results-for-breezula-clascoterone-in-treating-androgenetic-alopecia-3/
There was a decrease between the two.
Thank you admin for your continuous efforts to consolidate the news in the market regarding hair re-generation! don’t feel you hear it enough, this is the best source and we’re a lot of people following and reading the updates. Please continue keeping up the good work
Photographs?
Why can’t they show off their excellent results with some high quality before and after pictures?
Nothing questionable such as bright ‘before’ pictures and ‘after’ pictures taken in the cellar…..
Honestly, come on….. if the latest smartphone release was just a description with a list of specifications….. how many people would be interested???
Clascoterone
It is an effective treatment without doubt; which inhibits DHT with no side effects
I am optimistic in a year to treat baldness.
Yes Ahmed Bekeer, thanks; that’s word-for-word what you posted on HLC2020 as well, oddly. A bit early to advertise this. 😉
…Anyway, from reading this summary, it’s not clear at all to me how much it actually helps. For example, “13.8 hairs in the 5% solution ” — what does this even mean? I know that’s 13.8 hairs in the “target area”, but I’ve skimmed through the release and can’t find any definition of what that actually means. Did I miss that somewhere?
Also, what about photos? I thought the results were very promising? 🙁
I really *want* to be excited, but urghhhhhh!
Agreed with MC. Without proper definition of target area this is pure marketing.
Anyway they just finished phase 2 so we won’t hear until 5 years before it reaches the market.
It is not strange to guess the results of the treatment; for the first treatment after finasteride is aimed at dht without side effects; and is the only treatment among many treatments in clinical stages targeting dht
REMEMBER THIS NAME Breezula!!!
target area is 1cm^2. why don t you read the provided link
smeone , I did say I skimmed it 😉 Strange that I missed that! I even searched for “target area”, lol. Thanks for the clarification!
P-3074 (polichem Topical Finasteride) Phase Iii Just Ended
Wow
TissUse Smart Hair Transplants (SHT)
https://www.tissuse.com/en/products/regenerative-therapies/
Sounds wonderful.
Is it available?
Thank you very much for reaching out to us and for your interest in our SHT technology
We are still in the very late preclinical development stage but plan to move to a first clinical trial in the next years. We have just recently signed an agreement with a Japanese company to bring the treatment to the Japanese market.
However, this also means that it will still take a couple of more years before SHT will be broadly available as an alternative to conventional hair transplantation methods
Thank you for your interest in RT1640, we are not currently recruiting for any clinical trials. We are anticipating a release date in 2022.
Aclaris Therapeutics Announces Issuance of a Patent Covering the use of Ruxolitinib and its Deuterated Forms to Treat Alopecia Areata
https://investor.aclaristx.com/news-releases/news-release-details/aclaris-therapeutics-announces-issuance-patent-covering-use
Follica completed its clinical-stage development of a next-generation device and drug combination product for androgenetic alopecia, which is currently in an optimisation study.
Admin. Very very very encouraging news just came out for Follica. Can you please cover it.
Admin, can you please clarify about what the above comments are talking about when it comes to breezula being ineffective after 6 months? i just read someone saying it elsewhere and came back to this article to find the same thing.
the two links provided above show 6 month results being compared to baseline TAHC, whereas 12 month results are being compared to vehicle TAHC which i assume are two different comparisons? meaning we cannot conclude that it does in-fact go ineffective after 6 months?
would appreciate a clarification, thank you!
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