Category Archives: Cassiopea

FAK Inhibitors, Cassiopea and Drew Brees

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

Update: Make sure to read the comments from FAK inhibitor study co-author Dr. Kellen Chen in the comments section of this post.

FAK Inhibitor for Hair Loss

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.

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.

Follicum and Cassiopea Updates

I have covered both Follicum and Cassiopea numerous times on this blog in the past. Both companies just provided important new updates.

Follicum is based in Sweden and has done a stellar job in updating us regularly when it comes to the company’s peptide-based FOL-005 topical hair loss product. Projected release date: Probably 2022.

Cassiopea is based in Italy. Last year I mentioned how several very well known insiders of the hair loss industry have emailed me about their excitement in regards to Cassiopea’s Breezula topical antiandrogen product. Projected release date: Officially listed on their site as 2022.

Follicum Update

Follicum provided us with two updates this week.

  • The first was an important February 4th press release. In animal model in vivo testing, Follicum’s FOL-005 hair loss product was as successful as Minoxidil 5% in growing new hair. Moreover, while the latter must be used twice per day, FOL-005 need only be applied once per day.

Since results were dose dependent, I am hopeful that the company will test higher doses in future that may give even better new hair growth results. Considering that to-date, only two products (Finasteride and Minoxidil) have ever been officially approved to treat male pattern hair loss, this development is groundbreaking if true.

  • On February 9th, BioStock magazine published an interview with Follicum’s Research & Development director Maria Ekblad. Original Swedish version here. It seems like the latest version of FOL-005 that is being tested is a new formulation.

One interesting point made was that Follicum only managed to test the product for 3-month results in humans in recently completed Phase IIa trials. Ms. Ekblad hopes that longer-term usage will give even better results.

Follicum has historically worked with researchers at Charité Hospital (Berlin, Germany) and Bioskin (Hamburg, Germany). In late 2018, the company announced that they were now also working with the Centre for Skin Sciences at the University of Bradford (UK).

I would be very surprised if this once-a-day home use FOL-005 cream-like product ends up being less effective than Minoxidil. Unfortunately, it will probably not be released till 2021 at the earliest.

Update: Follicum has entered into a collaboration with Bioglan to make their FOL-005 hair loss topical cream. Follicum is also on target to get final US patent approval soon that will grant rights through 2032.

Cassiopea Summarizes 2018

Yesterday, Cassiopea (Italy) provided an update of its 2018 results.

Both the company’s hair loss product (Breezula) and acne product (Winlevi) are based on a synthetic antiandrogen called Clascoterone. Six-month interim Phase II results for Breezula® used in solution form in men with androgenic alopecia demonstrated statistically significant improvement in:

  1. Target Area Hair Count (TAHC)
  2. Hair Growth Assessment (HGA)

Nothing too meaningful as yet, but: there is excitement in the hair loss world about this product due to some results that were presented by Cassiopea at a conference in 2018. I cannot divulge my sources.

I would be surprised if Breezula does not provide significantly superior results to Spironolactone (another antiandrogen) in regrowing hair. Otherwise, it would not be worth pursuing.

Moreover, this product will be in topical form, and most likely result in minimal side effects. Most oral antiandrogens have significant side effects.