In a surprising twist, Samumed just rebranded itself as Biosplice Therapeutics (San Diego). CEO Osman Kibar has stepped down. The new CEO is Cevdet Samikoglu. In 2021, the company is supposed to release much anticipated results of Phase 3 clinical trials for its hair loss product.
Biosplice Therapeutics (formerly Samumed)
Biosplice also just raised $150 million in new equity financing investment. This latest round of financing will allow the company to accelerate the development and launch of its osteoarthritis drug candidate Lorecivivint.
The name Biosplice (rather than Samumed) more closely resembles the company’s alternative pre-mRNA splicing technology. It seems like splicing has becoming the company’s new buzzword or brand. Rather than the prior Wnt signaling pathway. From their updated site:
“Biosplice’s mission is to restore health by delivering first-in-class therapies that harness alternative splicing.”
Biosplice’s small molecule technology will make use of alternative splicing to target the CLK/DYRK family of kinases. Oncology and cancer treatment (Cirtuvivint) will be a key focus area of research. Alzheimer’s disease and other degenerative condition will also remain key target areas of treatment.
I was initially concerned at the rebranding and the new company’s focus shifting away from the Wnt pathway. However, then I noticed that their androgenetic alopecia drug has been renamed from SM04554 to Dalosirvat.
In my opinion, this is good news. If their soon-to-release Phase 3 clinical trial results are expected to be poor, why go through a product renaming?
Update: The guys on HLT seem skeptical. Some think that the renamed company might be preparing itself for an initial public offering (IPO).
Regarding Dalosirvat, the redone website says:
“The ongoing phase 2/3 study is fully enrolled with data availability expected in 2021.”
More information on the Wnt pathway activator Dalosirvat hair growth molecule can be found here.
Kintor Pharmaceutical (China) is definitely the real deal. And they are moving faster than any other company that I have seen in the hair loss industry.
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.
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.
Kintor Pharmaceutical (China) just 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.
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?
