Cassiopea Launches Trial For Female Alopecia
The anti-androgen drug Breezula is now being trialed for women with pattern hair loss.
Today on November 13, 2019, the pharmaceutical company Cassiopea announced that a new phase 2 trial for female androgenic alopecia is soon to be underway. This announcement follows approval from the German BfArM (equivalent to the US FDA) to begin the trial and Cassiopea will now proceed to enroll its first female patient in the study. Earlier this year, we received positive results from the 12 month Breezula trial in male androgenic alopecia where subjects who received the 7.5% Breezula solution twice daily showed an average increase of 14.3 hairs in a targeted area compared to baseline. It appears those results have encouraged the company to pursue an additional trial route for Breezula in women. For reference, Breezula is the brand name of the anti-androgen molecule clascoterone. A 1% solution of clascoterone is currently under review by the US FDA for treating acne and should be on the market in 2020.
Female Trial Details
As mentioned, Cassiopea has previously conducted multiple studies with clascoterone in acne and male AGA, and thus, they are able to begin this female trial at phase 2. Today’s press release mentions the upcoming trial will be a dose ranging study which is typically done at phase 2b. If this is correct, Cassiopea would be able to move into a final phase 3 trial immediately following this study which is good news for female patients who are eagerly anticipating a new approved treatment for hair loss.
Here are the specifics for the upcoming multicentered double-blind trial for female AGA:
- 6 month duration
- 280 female subjects between the ages of 18 – 55
- 4 different treatment groups including: 5% clascoterone solution twice daily, 7.5% clascoterone solution twice daily, 2% minoxidil solution twice daily, and vehicle twice daily
- Primary endpoints: terminal hair count increase from baseline and hair growth assessment score (HGA) at 6 months
Phase 3 Breezula Trial For Male AGA
Following the results of the phase 2 male AGA trial earlier this year, Cassiopea announced its plans to begin a pivotal phase 3 trial for males in Q4 2019. Since then, several positive developments have transpired for the company including the submission of a new drug application to the FDA for clascoterone’s use in acne and, now, the initiation of a new trial for female AGA. Also in this latest press release, Cassiopea mentioned they will meet with the FDA on November 13, 2019 to discuss the initiation of their phase 3 trial for males. As things seem to be going well, we can expect to hear another announcement from Cassiopea regarding the phase 3 trial within the next 2 months. A positive reminder, Cassiopea previously mentioned that its phase 3 trial for men would only be a 6 month trial, which is favorable to the typical 12 month phase 3 model. Once announced, Breezula would join Samumed’s SM04554 as the second drug to reach the phase 3 stage for treating baldness since finasteride did so in the late 1990’s.
Posted in Hair Growth Treatment
Samumed, Breezula, and Follica soon, Let’s GO!
Hi Admin … Novan Therapeutics has the same Story in Phase 3 … Acne and AGA
Nitric Oxide SB204 …
https://novan.com/pipeline/
What do you think about it?
John, thanks for sharing. It looks very interesting but I don’t see androgenic alopecia listed on the pipeline itself, but just below as a potential application. I think it’s possible to use the solution as an experimental treatment for AGA when it is released. But, I think the concentration of the formula will play an important role. For example, Cassiopea’s acne treatment will be 1% and the AGA version will be 7.5%. If the Novan drug has a high enough % it may be worthwhile. Have you been following this company much?
thank you for sharing. This brings a lot of hope to the female population dealing with hair loss, usually silently.
That’s great news. I think i will go back and use minoxidil because i’ve lost a lot of hair and i don’t know if i’ll recover all of them back or not. hopefully Breezula will hit the market very soon.
@ Admin, well I did not follow the Company Novan much. … Anyway I just wanted to Point that more companies are already in Phase 3 or late stage or even shortly befor release. … Besides Samumed and Cassiopea there are Almirall/Polichem, Novan, Medipost, Avalon Globocare, Giuliani, Direct Biologics , Exopharm and the Electro Cap from Madison and few more… I guess the Situation and near release Pipeline is much more positive then most of us would think.
Great news, both in Admin scooping and in substance!
I like this crowd around here, we’re down for the momentum. If the Giuliani trial is positive by January this whole thing is going to turn around. Not to mention a Tissuse trial coming soon!
Good to hear. If it is being trialed in Germany, how does this cross over to the US Market in terms of FDA review and approval for the necessary dosage and timing of availability in the US market? Or do we buy directly from Germany and consider it safe as their regulatory body should have good enough oversight? I did note this is drug is being trialed in the US for a different use (acne) at a lower dosage and should be completed in 2020, so hoping this expedites the process.
I also want to comment how shocking it is that this is the second drug since the late 1990’s! Our medical community has been asleep ? on this issue for 20 years!
I don’t know about you folks, but to me, this sound like putting plaster over a shotgun wound. Being that it contains Minoxidil or Finasteride, it don’t think it will be any better than taking the aforementioned orally. However, in all fairness, my opinion means f**k all since I am no tricholologist…lol!. With this current hair conference in Thailand, I hope some good news comes out of it…good news as in hair multiplication or the like.
C, the Breezula formula only contains the molecule clascoterone which blocks androgen receptors. It does not contain minoxidil or finasteride. The trial includes a group using minoxidil to compare the clascoterone drug to minoxidil. I hope that makes sense. Clascoterone is a new drug.
Will this be helpful in growing new hair if just to boost the existing hair growth?
Devit, it seems to have a similar effect as finasteride, but we will know best when it becomes more widely used. Finasteride has show to regrow some lost hair for people, but it serves best to prevent hair loss and does thicken hair which has become miniaturized.
Admin, I applaud you for your patience! 😉
Thank you Yoda! Some comments have to be taken light-heartedly 😉 We’re all in it together, sometimes.
What are the possible side-effects of this ? Because this is an anti-androgen. Even topical finasteride you get side effetcs.
Maybe for theory the possible side effects are the same as finasteride but the company is claiming that they don’t think it will cause harm because it does not affect the ‘hormonal profile.’ They also say the molecule is quickly metabolized to some form cortexolone. This is mentioned in the press release.
BTW … Again Allergan
https://www.fiercebiotech.com/biotech/allergan-pays-exicure-25m-to-discover-nucleic-acid-hair-loss-drugs
http://exicuretx.com/pipeline/overview.php