Category Archives: Cosmo Pharmaceuticals

Breezula, Androgen Receptors, Cassiopea, Clascoterone, Cosmo Pharmaceuticals, Topical Antiandrogen

Breezula Phase III Trials Begin

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Update: September 13, 2023

Breezula Cosmo Pharma
Breezula from Cosmo Pharmaceuticals.

Breezula Phase 3 Trial Enrollment Opportunities

Earlier this week, someone I trust sent me a link in regards to a new androgenetic alopecia related clinical trial that is taking place in New Jersey, US. There are two very interesting keywords in the URL that I was sent:

https://cenexelresearch.com/hri/trials/androgenetic-alopecia/?utm_source=Facebook&utm_medium=Paid&utm_campaign=Cassiopea%20CB-03-01%2F37&utm_content=Dermatology

The shortened version of the link on CenExel clinical research organization (CRO)’s androgenetic alopecia page does not mention the involvement of Cassiopea (or its new owner Cosmo Pharmaceuticals). Neither does it mention any product name.

However, in my last update of this post in June, I mentioned that Cosmo is finally starting its Breezula topical anti-androgen Phase 3 clinical trials in the US and Georgia. A total of 750 males will be enrolled between the two countries. The trials will end in January 2025. I wonder if the above mentioned trials in New Jersey are for Breezula?

Please do not bombard this company with calls and e-mails. It could ultimately even be some entirely new product, or a misread on my part. However, if you are serious and can make it to New Jersey regularly, think about signing up. Perhaps they also have a local residency requirement. Note that you have to be a male of 18 years age or older who has androgenetic alopecia.

I have written about Cassiopea/Cosmo/Breezula in well over a dozen past posts. Feel free to read all of them, going back to the very first one in 2014 when the product was known as CB-03-01. Its key ingredient is known as clascoterone, an androgen receptor (AR) antagonist. Similar to Kintor Pharma’s KX-826 (Pyrilutamide).

Update: June 29, 2023

Cosmo Begins Phase III Trials for Clascoterone (Breezula)

Cosmo Pharmaceuticals just announced the beginning of Phase III trials of clascoterone solution in males for the treatment of androgenetic alopecia (AGA). The name of this product is Breezula®  and it is a novel androgen receptor inhibitor. Trials will involve 750 patients in the US and Georgia.

The company’s acne product with the same clascoterone ingredient (but lower dose) is called Winlevi and is already available in the market. Actual Phase 3 clinical trial details for Breezula can be found here.

Key quote:

“If approved by the FDA, clascoterone solution has the potential to be the only topical androgen receptor inhibitor for AGA and the first drug with a new mechanism of action for the treatment of AGA in nearly three decades.”

Update: February 16, 2023 — Cosmo Pharma’s latest guidance states the following:

“Cosmo expects to have the first patient enrolled in the Breezula® (Clascoterone solution for androgenetic alopecia) phase III trial in males in Q1 2023.”

Also see Cosmo Pharma’s new page on Breezula. The company took over majority ownership of Cassiopea in December 2021 after being a part-owner for years (see bottom of this post).

Update: October 7, 2020 — Cassiopea (Cosmo Pharma) completed enrollment in its Phase II trials for female pattern hair loss. The 6-month study has enrolled 293 patients. The four-arm study will divide volunteers into four treatment groups: clascoterone solution 5% BID (twice daily); clascoterone solution 7.5% BID (twice daily); minoxidil solution 2% BID (twice daily); and vehicle BID (twice daily).

Before Breezula 2023, there is Winlevi 2021

Update: August 27, 2020 — Cassiopea’s Winlevi topical androgen receptor inhibitor has just been approved as an acne treatment by the US FDA. It is the first acne treatment with a new mechanism of action to be approved in 40 years. The key ingredient (clascoterone cream 1%) is the same as in the keenly awaited hair loss product Breezula. The latter will have a higher dosage.

CEO Diana Harbort quote:

Dermatologists have said targeting androgen hormonal activity in the skin is ‘the holy grail’ of acne treatment for both males and females.

I expect Breezula will not come to the market till 2023, assuming it gets final approval. However, some people plan to use Winlevi on the scalp, even though this is not recommended by the manufacturer.

Breezula Phase 3 Trials Delay

March 19, 2020

How things can change in just a few weeks. Breezula Phase 3 trials have now been delayed till 4th quarter 2020 or 1st quarter 2021. All due to COVID-19 (Coronavirus), which has hit Italy particularly hard. More information can be found in Cassiopea’s 2019 Annual Report which was released today.

The Clascoterone female pattern hair loss Phase 2 trials are on track to finish enrollment in 2Q 2020. Trials should be completed by year-end 2020. However, delays are still possible depending on progression and recurrence of the current pandemic.

Quote from the accompanying pdf:

“As part of the process in the NDA review, the FDA amongst other, also inspects the facility in which Clascoterone cream 1% is manufactured. Clascoterone cream 1% is planned to be manufactured at Cosmo Pharmaceuticals plant in Lainate in Italy. Given restrictions currently in place because of the COVID-19, the FDA had to postpone the inspection planned for March.”

Nevertheless, Cassiopea is still planning to release its Winlevi acne cream product by the end of this year.

Update November 13, 2019: Cassiopea’s women’s hair loss clascoterone solution Phase II trials starting soon in Germany.

April 16, 2019

Cassiopea (Cosmo Pharmaceuticals)

I have covered Italian company Cassiopea since 2014 (when it was called Cosmo Pharmaceuticals). The company is developing a topical anti-androgen hair loss product named Breezula (originally called CB-03-01). The chemical name for this product is Clascoterone. Note that Cosmo Pharma still owns 45 percent of Cassiopea.

Breezula will be available for both men and women. Several of my well known physician contacts in the hair loss world have told me great things about this product. Their feedback is based on what they saw at conferences or heard from colleagues.

Breezula Phase II Trials Very Successful

In July of last year, Cassiopea stated that the interim Phase II clinical trial results for Breezula were very positive. Today, they released twelve month Phase II trial results with the same conclusion:

Cassiopea announces very positive Phase II Twelve Months Results for Breezula® (Clascoterone) in treating androgenetic alopecia.

The presentation of the results is confusing, detailed, full of acronyms and somewhat open to interpretation. Note that “BID” in there stands for “twice per day” after conversion from Latin. Hopefully they release before and after photos at some point.

Also note that the previous 6-month interim report had 375 subjects, and the 12-month report has 344 subjects. The trial was conducted in Germany.

Breezula Target Area Hair Count Increase

Breezula Hair Count Increase
Breezula Hair Count Increase.

Best case result highlighted in yellow (14.3 new hairs per square centimeter, after 12 months of 7.5% BID clascoterone solution dosage). BID means twice per day.

Breezula Target Area Hair Width Increase

Breezula Hair Width Increase
Breezula Hair Width Increase.

Best case result highlighted in yellow (762.5 um width increase, after 12 months of 7.5% BID dosage).

My gut feeling is that Breezula will be at least as effective as Finasteride and Minoxidil.

Clascoterone Summary

Some key points from the above linked article from Cassiopea:

  • If approved, Breezula (Clascoterone) will be the first FDA-approved topical anti-androgen for the treatment of androgenetic alopecia.
  • Moreover, it would also be the first new drug approved for treating androgenetic alopecia since 1997. That year was when Propecia (aka Finasteride) was first approved to treat hair loss. That year was also when Tiger Woods first won the Master’s golf tournament. His 5th surprise victory in that tournament came this past weekend.
  • Based on these great results, Cassiopea plans to proceed with 6-month Phase III trials in men in the fourth quarter of 2019, after consultation with the FDA. The company is also going to start proof-of-concept trials in women.
  • Breezula works by blocking dihydrotestosterone (DHT) interaction with hair follicle androgen receptors.
  • Clascoterone does not interfere with testosterone and other hormones in male subjects. Libido and sexual behavior changes have so far not been observed in clinical trials. Moreover, due to its rapid metabolism and localized activity, Clascoterone (Breezula) does not produce any systemic side effects.

In the past, I used to often state that perhaps an initial cure for hair loss would entail the usage of a cocktail of products. Each working via different mechanisms and chemical or biological reactions.

It is looking likely that Breezula will be one of the main products in this cocktail.

Note that Clascoterone 1% cream to treat acne will be released by Cassiopea before Breezula. The acne product is called Winlevi.

Angela Christiano, Breezula, Cellmid, Cosmo Pharmaceuticals, JAK Inhibitors, L'Oreal, Organovo, Rapunzel, Sergio Canavero

New Treatments for Thinning Hair in Women

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Although a lot of important developments have occurred in the hair loss world in the past several weeks, I have not been excited by most.

New Treatments for Hair Loss in Women

— A few days ago, the New York Times had a fairly detailed and interesting article on thinning hair in women. The article includes quotes from well known experts frequently mentioned on this blog such as Dr. Joseph Greco and Dr. Angelo Christiano. It seems like Dr. Christiano has helped start a company (called Rapunzel of course) where she will focus on hair multiplication via cell culturing.

I am not too excited about this as yet since clinical trials are 1-2 years away. In essence, this is yet another “cure is five years away” type venture. Even that timeline is optimistic based on the assumptions that she raises the requisite funds and that each stage of clinical trials progresses as planned. The one redeeming factor is that Dr. Christiano is very passionate about helping women with hair loss, perhaps largely because she also suffers from hair loss and wears a wig.

— The other interesting item from the above mentioned New York Times article was an explanation on why Latisse (Bimatoprost) will probably not work as well on the head as it does on eyelashes. According to the Cleveland Clinic’s Dr. Melissa Piliang, a well known hair loss researcher and dermatologist, Latisse works by shifting hair that is in a resting phase into hair that is in a growth phase. However, while 70 percent of eyelash hair is usually in resting phase, only 10-20 percent of scalp hair is usually in resting phase. I wonder if that 10-20 percent potential new hair growth is enough to make Bitamoprost at least as good as Minoxidil?

— Cellmid, a company that I discussed earlier this year, just announced very good results from an independently conducted trial of its FGF-5 inhibiting drug évolis ONE. I would be a lot more excited about this product if were not based on naturally occurring botanical extracts. And if there were more positive anecdotal forums posts from existing Australian users of the product. I just do not believe that any natural hair loss product can cause regrowth in bald areas of the scalp. In any case, their CEO Maria Halasz has Tweeted to me that the product will be in pharmacies in May.

— Italian company Cosmo Pharmaceuticals changed the name of its yet to be approved CB-03-01 topical anti-androgen product to Breezula per a March 25, 2015 detailed company presentation. Strange choice of name. The company also changed its own name to a more Italian sounding Cassiopea in April 2015.

— The two main stories in the hair loss world last year both involved JAK inhibitors reversing alopecia areata. The before and after photos in both cases (see bone marrow cancer drug Ruxolitinib and arthritis drug Tofacitinib) were mind blowing and took the global media by storm. This month, yet another JAK inhibitor (cancer drug Baricitinib) proved to have similar results, but the publicity surrounding this development was modest.

— Although related to the skin rather than to hair, cosmetics giant L’Oreal ‘s and 3D organ printing giant Organovo’s newly announced partnership in research is one to watch closely. The human skin is very closely related to hair, and L’Oreal has already made its presence felt in the hair world due to its much hyped yet to be released gray hair prevention pill.

— Finally, I was surprised that the crazy Dr. Sergio Canavero of the full body transplant (or “head transplant”, as has been falsely named by much of the media) fame has already found a patient. So they are likely to proceed with this insanity in 2016. Even crazier, it seems like Dr. Canavero got over 100 volunteers asking him to be the first person to get a new body. I cannot imagine that this will ever work. More on Valery Spiridonov. You can also read this interview with him and this one with Dr. Canavero.