Category Archives: Cassiopea

Cassiopea, Drew Brees and FAK Inhibitors

An interesting week in hair loss news warrants a wide ranging post.

Cassiopea Topline Results for Female Hair Loss

We are eagerly awaiting Cassiopea (Italy)’s Phase 3 Trials for Breezula for androgenetic alopecia (male pattern hair loss). However, several days ago, the company posted an encouraging update on its Phase 2 proof of concept trial for clascoterone use in female hair loss patients. Clascoterone is a topical androgen receptor inhibitor, and its hair growth benefits are almost certainly going to be greater in men.

The trials encompassed 293 women aged between 18-55. The were split into four groups: 5.0% and 7.5% twice daily application of clascoterone solution; versus twice daily 2% Minoxidil or vehicle. Only the subgroup with women less than 30 years of age receiving twice daily application of 5% clascoterone solution showed statistically significant differences from baseline in  total hair count at month 6. No safety issues were detected.

Cassiopea Clascoterone Hair Loss
Cassiopea pipeline for clascoterone to treat hair loss.

Drew Brees Hair Transplant

Drew Brees is a superstar quarterback in American Football (NFL). The 42-year old retired in 2021 after a stellar career. He was also well known for his early hair loss and receding hairline…until this week. Looks like he got a hair transplant with excellent results.

Drew Brees Hair Transplant
Drew Brees hair before and after.

I have discussed numerous other celebrity hair transplant results over the years. Among the most famous athletes who got hair transplants include Wayne Rooney and Brian Urlacher. Possibly also Lebron James.

FAK Inhibitor for Hair Loss

I saved the most important news for last. In recent days, a few people discussed this Stanford University research (first posted by “DrPhil”) on our hair loss chat.

FAK Inhibitor Hair Growth
FAK inhibitor skin healing and hair follicle regrowth at 180 days. Source: Nature Communications.

The researchers found that blocking mechanical signaling via FAK  (focal adhesion kinase) inhibition promotes regenerative skin healing. Moreover, this restored skin includes hair follicle regrowth in addition to normal collagen fiber architecture. Most importantly, this hair regrowth was shows in both mice and pigs.

This is significant because porcine skin has striking similarities to human skin. The researchers used a pharmacologic inhibitor of FAK (FAKI) called VS-6062. This pharmacologic blockade of mechanical signaling resulted in skin with less scar formation and more hair.

The FAK was delivered to wounded skin using a biodegradable and biocompatible hydrogel scaffold.

Better than Verteporfin?

Per @DrPhil on our chat:

“This VS-6062 FAK inhibitor does the same thing as verteporfin, but it inhibits a target which is upstream of YAP. Verteporfin only inhibits YAP, while VS-6062 inhibits FAK (which controls YAP) and also other targets. FAK inhibitors can also be applied topically, with no injections required. Moreover, VS-6062 has already gone through Phase 1 and Phase 2 clinical trials to treat cancer.”

According the Stanford team, porcine serum FAKI concentrations following local treatment were almost undetectable. In fact they were less than 1% of the maximum tolerated human dose observed in a previous Phase 1 clinical trial. So safety issues are likely to be nonexistent in my opinion.

Interestingly, the earlier verteporfin research was also undertaken at Stanford, via the Longaker Lab.

Winlevi: Cassiopea’s Breakthrough Acne Treatment

I first wrote this post on Winlevi and acne in 2019 and am updating it again. Winlevi clascoterone 1% cream is a first-in-class androgen receptor inhibitor that can be used by both males and females. Also see my related posts on clascoterone based hair loss treatment Breezula.

Update: November 1, 2021 — Sun Pharma announces that Winlevi Clascoterone 1% cream is now available for sale in the US. To be used for the treatment of acne vulgaris.

August 1, 2021

Winlevi, Cassiopea and Sun Pharma

Winlevi (clascoterone cream 1%) will now be released in the US market in the fourth quarter of 2021. Official website here.

On July 26, 2021, Cassiopea announced that it was partnering with Sun Pharma in order to commercialize and market Winlevi in the US and Canada. On July 29, 2021, the company also released its first half 2021 results.

The US FDA approved Winlevi® (clascoterone cream 1%) in August 2020 for the topical treatment of acne vulgaris. This prescription drug is a topical alternative to Accutane and Spironolactone. It is an anti-hormonal treatment for acne that targets the androgen receptor. It works by reducing sebum production and scalp inflammation.

Many people will inevitably try to use Winlevi on their scalps for hair growth (via off-label prescription). This is not recommended by the manufacturer.

August 27, 2020

Winlevi Approved by the FDA to Treat Acne

Winlevi Clascoterone Cream 1% for Acne.
Winlevi Clascoterone Cream 1% Acne Treatment.

Cassiopea’s Winlevi topical androgen receptor inhibitor was just 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 US FDA is also reviewing a new drug application (NDA) for clascoterone cream 1% to treat acne.

More information from Cosmo Pharma (Ireland — COPN:SWX), which owns 45 percent of Cassiopea (Italy — SKIN:SW).

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.”

August 23, 2019

I have covered Italian company Cassiopea numerous times on this blog. Primarily due to its Breezula topical product for male pattern hair loss. Earlier this year, Cassiopea announced very good 12-month Phase 2 clinical trial results for Breezula.

Clascoterone and Acne

Cassiopea is also working on an acne product called Winlevi. Both Breezula and Winlevi are based on the same key ingredient: Clascoterone. However, the dosage in the latter is significantly lower at 1%. This acne product is almost ready to come to market per Cassiopea’s product pipeline.

Winlevi (Clascoterone) Pipeline.
Winlevi clinical trial and NDA filing schedule.

 

Earlier this week, Cassiopea made a major announcement. The company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for clascoterone cream 1% for the treatment of acne.

My Thoughts

Some interesting points in the press release and my thoughts:

  • Clascoterone cream 1% targets androgen receptors at the site of application. This inhibits the local (skin) effects of dihydrotestosterone (DHT). Apparently, DHT is a key driver of acne lesion development. Most people wrongly assume it is solely testosterone.
  •  This acne treatment product will be safe to use in both males and females.
  • If approved, clascoterone cream 1% will represent the first new mechanism of action in the treatment of acne in almost 40 years. Interestingly, if Breezula is approved for hair loss in 2021, it will be the first new topical or oral treatment for hair loss in almost 25 years.