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 long-time blog readers will agree. Moreover, they are conducting hair loss trials for two separate androgen receptor products, and that too in two countries. For both males and females.

Update: December 1, 2022

Kintor Phase 2 Results for KX-826 in Females

Not surprisingly, yet another positive Kintor update. Their Pyrilutamide (KX-826) phase 2 clinical trial results for females with androgenetic alopecia just got released. And the findings are positive. Total area hair count (TAHC) increased 11.39 hairs per cm2 compared with the placebo group after24 weeks of treatment. It seems like they are going with a dosage of KX-826 5mg (0.5%) once a day, even though twice a day was also tested.

The overall safety profile of Pyrilutamide in females was good, and no participant needed to drop out due to any adverse event. Note that these results, whilst encouraging, are less than half what was seen in men (22.73 hairs per cm2 increase). See further below for the prior updates on the male trials. Both these Phase 2 trial were conducted in China, and Kintor is epxected to conduct Phase 3 trials  for men an women in China too.

Update: November 24, 2022

Phase 1 Trials for GT2009 a Success

Kintor’s just announced positive top-line results for its Phase I clinical trial of GT20029 for the treatment of androgenetic alopecia (AGA) and acne. GT20029 is the world’s first t1opical Proteolysis Targeting Chimera (PROTAC) compound that has completed Phase I clinical trials. It works by degrading the androgen receptor (AR). The topical administration of GT20029 was safe and well-tolerated, with limited systemic exposure.

Update: August 29, 2022

Kintor Releases KX-826 Phase 2 Trial Results in Males

Kintor just released the Phase 2 results from China on their website and they are positive. Note that this Pyrilutamide (KX-826) topical hair loss product is an androgen receptor antagonist. In contrast, existing hair loss products Finasteride and Dutasteride are both oral DHT inhibitors.

Key quote:

“The results showed that the KX-826 (0.5%) 5mg BID group demonstrated significant improvement in TAHC as compared with the baseline (increased by 22.73 hairs per cm2; and placebo group (increased by 15.34 hairs per cm2) after 24 weeks of treatment. The recommend phase III dose is determined as KX-826 (0.5%) 5mg BID.”

Note that BID means twice daily. A total of 120 Chinese adult male subjects with a mean age of 35.6 were enrolled in the study. All had a Hamilton-Norwood classification III or higher balding pattern. They were equally divided into four groups:

  • KX-826 2.5 mg (0.25% concentration) twice daily.
  • KX-826 5 mg (0.5% concentration) once daily.
  • KX-826 5 mg (0.5% concentration) twice daily.
  • Placebo.

The overall safety profile of KX-826 was good per these results. No serious adverse event (SAE), adverse drug reaction (ADR), or death occurred. After 14 days of topical application, the blood concentration of KX-826 was very low in all dose groups.

Kintor says that it will accelerate the clinical progress of KX-826 and GT20029 in order to:

“Bring more innovative and effective treatment options to the hundreds of millions of people suffering from AGA and acne vulgaris worldwide.”

Update: August 11, 2022

Pyrilutamide Phase 2 Clinical Trial Results

Great news per a Chinese contact. It looks like Kintor may finally present the results of its Phase 2 Chinese trials of Pyrilutamide (KX-826) for hair loss on September 3 at 8:20 pm . The presenter will be Dr. Zhou Cheng from Peking University People’s Hospital (where Kintor’s Phase 3 trials are also being conducted right now).

Note that Kintor is not named in the presentation. However, I noticed that the chairman of this group of presenters (from Peking University) is Dr. Zhang Jianzhong. This man is listed in Kintor’s press releases as the principal investigator! So I decided to update this post as it looks believable now after months of waiting and delays.

The possible presentation (after translation) is titled: “New progress in diagnosis and treatment of androgenetic alopecia.” Please note that this KX-826 androgen receptor antagonist product is unlikely to bring back long lost hair in totally bad areas of the scalp. All I am hoping for is something as good as Dutasteride, but with a different mechanism of action.

Kintor Pharma Presentation
Kintor Pharma presentation of Phase 2 clinical trials results. Will occur on September 3 in China at a Dermatology conference.

Kintor Pharmaceutical Update: Three Clinical Trials

Update: August 9, 2022 — Kintor just completed enrollment of 92 subjects in China for Phase 1 trials of its GT20029 hair loss product. This proprietary Proteolysis Targeting Chimera (AR-PROTAC) product is the world’s first topical androgen receptor (AR) degrader compound to enter clinical trials. They will test a gel or tincture per the press release, and results will be finalized at the end of 2022.

Update: August 3, 2022 — Kintor just completed patient enrollment of 121 subjects in its Phase 2 clinical trials of KX-826 (pyrilutamide) in the US. This  topical androgen receptor antagonist product will be used to treat androgenetic alopecia.

Update: July 2022 — The China Phase 2 trial results for pyrilutamide for hair loss will occur at the postponed 28th Annual Meeting of the Chinese Society of Dermatology. It runs from August 31-September 4, 2022 in Shenyang.

Updates in April 2022

Some very unique updates in our Kintor channel in the hair loss chat this past week.

  1. Interesting new Powerpoint presentation.
  2. Kintor will present the results of its Phase 2 clinical trials (of KX-826, aka Pyrilutamide) for androgenetic alopecia at a “high-profile symposium” in June 2022.
  3. Some people managed to view a classified Phase 2 results slide that concluded Pyrilutamide’s hair growth effect to be similar to Dutasteride. This would be amazing if true, since Pyrilutamide (targets the AR receptor) is totally different from Dutasteride (targets DHT). Anecdotal reports for now, but seem to be causing a lot of excitement.
  4. A number of people are starting to report their results from using KX-826 via a Group Buy. I cannot encourage such experimental behavior, but I am following the reports keenly. Here is one I found on Reddit. Best of luck to these pioneers.

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! Update: Now begun.

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?

Effective Cell Therapy for Hair Regeneration

Update: Epibiotech CEO Sung (who is the author of the new paper covered in this post) is answering our questions in the comments this week. Please note that English is not his first language.


Earlier this month, Epibiotech CEO Jong-Hyuk Sung published a detailed new paper titled “Effective and economical cell therapy for hair regeneration.” It was widely covered in South Korean media (h/t “Theo”, who also sent me this update on Mr. Sung’s presentation covering the paper). They call him Seong Jong-Hyeok in that article.

My interest piqued when I read such a thorough scientific paper from a CEO (almost unheard of in this industry). I showed it to a well known hair transplant doctor, and he found it to be a great summary. I also e-mailed one of Epibiotech’s media representatives with some questions, but no response so far.

Adipose, Dermal Papilla and Dermal Sheath Cells

Note that Dr. Sung has publiched numerous papers on adipose-derived stem cells (ADSC) and hair regeneration (and wound healing) for 15 years. This CEO seems to be a scientist first and foremost, rather than a business person.

This latest paper covers the three main types of cell based hair regeneration treatment strategies that are currently being developed:

  1. Adipose-derived stem cells (ADSC or ASC).
  2. Dermal papilla cells (DPC).
  3. Dermal papilla epithelial cup cells, better kown as dermal sheath cup cells (DPSC or DSC).

The paper also mentions the manufacturing of hair organoids using induced pluripotent stem cells. Including a shout out to Dr. Takashi Tsuji.

  • Note that Shiseido (including its use of Replicel’s technology) is working on a hair regeneration treatment involving culturing of dermal sheath cup cells. More details here.
  • Also note that in the past, Aderans and Intercytex both saw some succes in hair growth via dermal papilla cell culturing and injection into balding scalps. HairClone is currently trying something similar.

Dr. Sung’s company Epibiotech is ultimately driven by “Off-the-shelf” allogeneic DPC therapy. It aims to begin Phase 1 clinical trials for its EPI-001 dermal papilla cell hair multiplication treatment in 2023. We are all hopeful that things will move faster in Asia in comparison to the US or Western Europe. The company can already mass-produce dermal papilla cells with hair growth ability using spheroid culture, hypoxic conditions, and growth factors.

Cell Therapy Hair Growth
Cell therapy for hair growth. Adipose, dermal papilla and dermal sheath cup cells. Source: Biomedicine & Pharmacotherapy, January 2023.

Adipose Derived Stem Cells

Given the author’s background, the paper is especially detailed when it comes to ADSC (ASC). Dr. Sung highlights the pros and cons.

    • Adipose-derived stem cells are easy to access and isolate in large quantities. This is not true when it comes to dermal papilla cells and dermal sheath cup cells.
    • While ASCs promote hair growth through the paracrine effect, they have a poor potential in hair neogenesis. Dr. Sung suggests further development in methods to enhance the trichogenecity of ASCs.

Other New Studies on Hair Regeneration

As if this was not enough, two new papers on hair regenearation came out in the past month.

  • A lierature review from Japan coveres numerous cell therapies for hair regrowth. This includes mesenchymal stem cell (MSC) implantation. Adult sources of MSC include: adipose tissue (including SVF); bone marrow; DPC; DSC; placenta and umbilical cord. The paper also analyzes non-cell therapies, including exosomes, extracellular matrix, platelet-rich plasma, and the MSC secretome. The last mentioned “comprises bioactive materials, such as growth factors, cytokines and nucleic acids that play an important role in regulating the hair follicle cycle and regeneration”.
  • A new study from China on microenvironmental reprogramming of human dermal papilla cells for hair follicle tissue engineering.
  • And finally, a recent video on regenerative medicine for hair loss starring Dr. Jerry Cooley (interviewed by Dr. Robert Haber).

Hair loss treatment and cure related news updates.