Kintor Pharmaceutical to Start Phase 3 Trials


Kintor Pharmaceutical (China) is definitely the real deal. They are moving faster than any other company in the history of the hair loss industry. I think all my readers will agree.

Kintor will Start Phase III Trials in China in January 2022

In the latest update from today (November 24th, 2021), Kintor Pharmaceutical announced that it will begin Phase 3 trials in China in January 2022!

The company’s IND application for the pivotal study (phase III) of pyrilutamide (KX-826) was cleared by China’s National Medical Products Administration. KX-826 is the first androgen receptor (AR) antagonist to enter phase III clinical trials anywhere in the world.

This is perhaps the best news in the hair loss world so far in 2021.

Update: November 12, 2021 — Kintor Pharma just started Phase II clinical trials in women in China with a first dose of pyrilutamide (KX-826). This trial pertains to androgenetic alopecia in women (i.e., female pattern hair loss).

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?

Mass Hair Loss Event and Paralysis Cure

It has been a while since I wrote a post on brief news items and thoughts related to hair loss.

The Worst Year in Hair Loss

Alyssa Milano Covid-19 Hair Loss
Alyssa Milano Covid-19 Hair Loss. Source: Instagram.

The stories about Covid and hair loss never stop. It first got major attention in 2020 due to actress Alyssa Milano’s experience.

I am skeptical about whether it is: the actual Coronavirus causing the hair loss (usually lasting several months); Or whether it is major emotional and psychological stress (i.e., telogen effluvium) causing the hair loss. It also seems like far more women then men are reporting worsening hair loss since the pandemic began. At least on social media.

In any event, several days ago “The Atlantic” magazine published  a hair loss article with a great title: “The Year America’s Hair Fell Out“. The author deems the pandemic as “a near-perfect mass hair-loss event“. At this point, the one year is in reality 1.7 years of masking , lockdowns and vaccination. That is unless you live in Sub-Saharan Africa, where life continues as normal despite only a five percent vaccination rate.

The author also points out the numerous ineffective hair products and outlandish hair growth claims all over the internet. Natural  products and hair loss supplements are especially a dime a dozen. NPR now also covering the story yet again.

Will a Paralysis Cure Arrive Before a Hair Loss Cure?

Scientists from Northwestern University in Chicago have successfully created a gel that reversed paralysis in mice. This was the biggest news in  the medical world this week. The actual study is titled: “Bioactive scaffolds with enhanced supramolecular motion promote recovery from spinal cord injury”.

The gel enabled paralyzed mice to walk four weeks after initial injection. The mice given a placebo never regained the ability to walk. 76 mice were split between the treatment and placebo groups. Apparently, there are 1.5 million people in the US who are living with paralysis.

The gel sends biological signals that trigger nerve cell and blood vessel regeneration. It also restores essential fat insulation (myelin) around nerve cells and removes scar tissue that could hinder cell regeneration. Best of all, this gel is inexpensive to produce. In the future, it could also be tested on patients with Parkinson’s and Alzheimer’s disease.

Extracellular Vesicle Mimetics (EMs) and Hair Growth

I am always on the lookout for new studies on exosomes and hair growth. Note that exosomes are also known as extracellular vesicles (EVs). Large-scale production of EVs remains difficult. Recently, extracellular vesicle mimetics (EMs) engineered by extrusion through various membranes have emerged as an alternative approach for large-scale production of EVs.

A new study from South Korea made an interesting finding. The research scientists developed something called macrophage-engineered extracellular vesicle mimetics (MAC-EMs). The MAC-EMs when injected induced hair regrowth in mice as well as hair shaft elongation in a human hair follicle. Encouraging signs that suggest the potential of MAC-EMs as an alternative to EVs when it comes to use for hair growth.

Hormonal Treatments

I just saw this almost 1,000 page thread on HLT a few years late. I only went through 5 pages so far, but it is great. I have frequently cited the crazy hair regrowth that balding MTF transgender persons experience after they start “kitchen skin” hormonal treatments. In many instances, they get back long-lost hair in areas that have been bald for many years.

I am always surprised that non-transgender people almost never seem to attempt this all-out approach. A male obviously never wants to become feminized. However, there are enough desperate males who have major hair loss related depression. I would have thought that many would give in and go for this “side effect guaranteed”  and “hair growth guaranteed” approach.

Lo and behold, the above HLT thread that I discovered late was started by someone “Bridgeburn” who is NOT transgender. He just wanted to regain his hair and throw the kitchen sink of hormonal treatments into the mix. He has seen amazing hair regrowth in the process. I really like his signature:

“Youth is more valuable than gender.”

Among the hair loss products that he takes or took regularly include:

  1. Estradiol (aka Estrogen).
  2. Cyproterone Acetate (an anti-androgen).
  3. Dutasteride (the strongest available DHT inhibitor).
  4. Minoxidil.

Hair loss news blog. Hair cloning for baldness.