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.

Kintor Pharmaceutical from China

Kintor Pharmaceutical (China) is definitely the real deal. And they are moving faster than any other company that I have ever seen in the hair loss industry.

Update: September 8, 2021 — Kintor Pharma just announced that its Phase II clinical study for KX-826 to treat androgenetic alopecia was a success. Primary endpoint was met. More detailed results will be released later per CEO Dr. Youzhi Tong. Phase III clinical trials in China will commence in the fourth quarter of 2021. Even better, Phase II trials are also currently taking place in the US. And Phase II trials for women will take place in China

Update: July 11, 2021 — The US FDA just approved Kintor’s Phase II clinical trial for Pyrilutamide (KX-826) to treat androgenetic alopecia. Note that the company’s trials in China are already mid-way through Phase II per their pipeline page.

They area also working on another hair loss product named GT200029 that is an “AR-PROTAC” compound. Its Phase 1 trials will start in China this month.

April 15, 2021

Kintor Pharma: AR Antagonist and AR Degrader

Earlier today, it was announced that Kintor received approval in China to begin clinical trials for GT20029. This product will be in tincture or gel format, and will be tested for the treatment of androgenetic alopecia and acne.

  • The GT20029 product is an androgen receptor degrader (AR Degrader). It is developed using Kintor’s proprietary Proteolysis Targeting Chimera (PROTAC) platform. According to the press release, this is the world’s first topical androgen receptor (AR) compound (AR-PROTAC) to enter clinical trials. GT20029 degrades the AR protein via the E3 ubiquitin ligase pathway. During preclinical studies, GT20029 did not cause any notable side effects or systemic drug accumulation.
  • Note that Kintor’s main product for treating male pattern hair loss is KX-826 (Pyrilutamide) and is an androgen receptor antagonist (AR Antagonist). I covered the latter in prior updates to this post if you read till the end. KX-826 is currently in Phase 2 clinical trials in China and in Phase 1 trials in the US.

Note that Cassiopea’s Breezula (Clascoterone) is an AR antagonist that is well ahead of KX-826 when it comes to clinical trial stage. Kintor’s website has a very interesting article discussing both AR antagonist products and hair loss in China in general.

Make sure to also read my related past post on destroying the androgen receptor to reverse hair loss.

Feb 2, 2021

Clinical Trial Status

Kintor’s investigational new drug (IND) application of GT20029 for androgenetic alopecia and acne vulgaris was accepted by the National Medical Products Administration (NMPA) of China.

Kintor has moved forward with its trials faster than any other hair loss company. I am glad to see a Chinese company finally entering the hair loss cure market. Scientific and technological progress seem to happen faster in China than in the west. Hopefully, clinical trials for hair loss products will follow the same pattern.

Side note: In July 2020, Kintor and Applied Biology (US) collaborated on using Proxalutamide for the Treatment of COVID-19. There is a school of thought that suggests anti-androgens could help reduce Coronavirus fatalities. To date, more men have died from the disease then have women.

Below is the pipeline from Kintor’s website:

Kintor Pharmaceutical Pyrilutamide Pipeline
Kintor Pharmaceutical Pyrilutamide Androgenetic Alopecia Pipeline.

 

Kintor Pharmaceutical (China) also recently completed the enrollment of 120 patients in its Phase II clinical trials for Pyrilutamide for hair loss. See the bottom half of this post for my original discussion on Kintor. Their stock is traded on the Hong Kong Hang Seng Index.

Key quote from CEO Dr. Youzhi Tong:

“We will accelerate the progress of its phase II/III clinical study so as to bring benefits to the people suffering from alopecia as soon as possible.”

May 26, 2020

A new Chinese company named Kintor Pharmaceutical is working on an interesting hair loss drug called Pyrilutamide . It is extremely rare to hear about any Chinese company involved in hair loss cure research. Very strange, considering the country’s rapid pace of scientific advancement and massive population. Moreover, Chinese men and women are nowadays balding at much faster rates than in the past.

Update: August 4, 2020 — Phase Ib trials are now complete.

Kintor Pharmaceutical and Hair Loss

Four days ago, China-based Kintor Pharmaceutical (also known as Suzhou Kintor Pharmaceuticals) got significant Chinese media coverage. This interest was related to the company’s prostate cancer, breast cancer and hair loss drugs.

Earlier this month, Kintor Pharmaceutical also had a very successful IPO in Hong Kong.

While the company’s main focus seems to be its prostate cancer and breast cancer drugs, its androgenetic alopecia drug trials are also advancing rapidly. Their main androgen receptor blocking drug candidate is called Pyrilutamide (KX-826) and it is applied to the scalp topically. The company’s Proxalutamide drug slows or stops cancer cell growth by entirely inhibiting androgens.

Pyrilutamide

The one disappointing news is that Kintor aims to take on Johnson & Johnson’s Minoxidil. This could mean that topical Pyrilutamide is unlikely to be much better than Minoxidil. I hope I am wrong. Recently completed phase one trials in China proved that Pyrilutamide is safe and causes no major side effects in humans.

Kintor is currently conducting phase 2 clinical trials for Pyrilutamide on 160 men in China, and phase 1 trials on 30 men in the US. Phase 3 trials on 600 people in China, the US and Japan are planned for as soon as 2021. I would guess that the US FDA and Japanese PMDA will never accept Phase 2 results from China as any kind of proof to proceed to Phase 3 trials in the US and Japan.

So how can the company proceed so fast in the US and Japan?

Hair loss news blog. Hair cloning for baldness.