Hair Loss Cure 2020

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: 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?

The most “natural” way of regrowing lost hair is via wounding or intentional injury. Hence the massive popularity of at-home microneedling and dermarolling for hair growth.

However, no-one truly understands the biology of wound healing spurred new hair follicle growth. We have been waiting for 15 years for Follica to come through.

I am updating this post because an important new study on wound healing and hair follicle mesenchymal stem cells was published in June 2021. The researchers behind this paper concluded the following:

“During wound healing, dermal papilla (DP) and dermal sheath (DS) cells move towards the wound, but do not directly participate in follicle neogenesis.”

They further elaborate that follicle neogenesis during wound healing is a genuine de-novo process. The new follicle formation does not rely on any preexisting components from preexisting follicles.

October 24, 2020

Wound Healing and Hair Follicle Growth

Two recent papers published important new findings in regards to wound healing and skin regeneration.

Wound healing via skin regeneration is often accompanied by hair follicle regeneration. Or even by brand new hair follicle neogenesis (e.g., Follica). Note that this hair growth after wounding phenomenon was even being researched in the 1950s and 1960s.

Thousands of hair loss sufferers around the world are trying out at-home microneedling and dermarolling. Many of them have seen significant success, although one has to be careful with this type of scalp self-injury. On our hair loss chat, the most interesting recent discussion is around wounding depth levels.

Human embryonic and neonatal skin has the potential to regenerate after wounding. This includes fully functioning hair follicles. However, adult skin no longer has such regenerative capabilities. Researchers have been trying for years to find ways to coax salamander-like regenerative powers in humans. If not for whole limbs, at least for hair growing skin to cover baldness for our sake.

New Studies on Skin Regeneration and Wound Healing

1) In September 2020, a team that included Dr. Jeff Biernaskie published a study on the regenerative potential of dermal fibroblasts during wound healing. They identified a specific population of progenitor cells that reside within the dermis and which aid in wound healing.

Skin Regeneration Regulators. Source: Bernaskie Lab GitHub.

The research is shared on GitHub. Also see Biernaskie Lab. According to the findings, Runx1, retinoic acid, and Hic1 control mesenchymal regenerative capabilities.

According to this summary, Dr. Biernaskie (whose work I have covered in the past) said that they have shown the following:

“You can alter the wound environment with drugs, or modify the genetics of these progenitor cells directly. Both are sufficient to change their behavior during wound healing. And that can have really quite impressive effects on healing that includes regeneration of new hair follicles, glands and fat within the wounded skin.”
“It suggests that the adult wound-responsive cells do in fact harbor a latent regenerative capacity, it just simply needs to be unmasked.”

2) Also in September 2020, a new study from the University of Washington identified Wnt transcription factor Lymphoid enhancer-binding factor 1 (LEF1) as the key factor in adult skin regeneration.

LEF1 gene expression in fibroblasts has the potential in adult skin to repair itself like the skin of a newborn baby. This skin can also grow new hair follicles.

Interview with lead author Dr. Ryan Driskell.

“We identified a genetic factor that allows adult skin to repair itself like the skin of a newborn baby.”

Hair, Skin and Wounds all Interconnected

While researching for this post, I could not believe the number of diverse past posts that I have written on this blog that have focused on skin regeneration, wound healing and hair formation.

- I have covered PolarityTE a number of times. The company claims that its technology can grow new skin with fully intact sweat glands and hair follicles. Also see my past posts on companies involved in 3D bioprinting of hair and skin.
- In 2020, I wrote about hair-bearing human skin that was generated entirely from pluripotent stem cells.

Regenerating hair follicle after wounding. — Wound induced single hair follicle neogenesis in a bald old man.

Another item of interest entails activation of the Sonic Hedgehog Pathway and subsequent wound healing and hair regrowth.
Also see the connection between wounding, interleukin-1 and hair growth.
For a fascinating and yet comedic take, I recommend reading “never too old to regenerate hair“.
Follica and wounding. And of course the popular related subjects of microneedling and dermarolling that I have written about a number of times.
Also see my posts on the Uniformed Services University and its work to create cell-based skin substitutes for the US military. I have also mentioned Wake Forest and its skin cell printing project in the past.
Several fibroblast growth factors promote hair follicle growth after wounding. See the FGF section in my post on growth factors in PRP. And this FGF-9 patent from U Penn.

Renowned hair loss researchers such as Dr. George Cotsarelis, Dr. Luis Garza, Dr. Elaine Fuchs and Dr. Mayumi Ito have all also conducted frequent research on skin regeneration. I have discussed their work in past posts if you search for their names.

My gut feeling is that whenever there is a fully effective cure for hair loss, there is a strong likelihood that there will also be a cure for quality skin regeneration.

Skinregeneration.org

The authors of the second study that I linked to earlier have started a new site called skinregeneration.org. The site’s mission is to provide a platform for scientists to easily query large datasets that focus on skin wounding and scarring repair.

For further information, see the Driskell Laboratory site at Washington State University.

Skin Gun and Spray-On Skin

It seems like the technology to repair skin has improved significantly during the past decade. There is an especially unmet need when it comes to treating skin that has been burnt badly.

One of the technologies that I used to very curious about is the skin gun that was widely hyped in 2011. I have not heard much about this in recent years. RenovaCare acquired the technology in 2013. The company’s skin gun and spray-on stem cells for wound healing are trademarked under the names SkinGun™ and CellMist™.

Kintor Pharmaceutical from China