Epibiotech EPI-001 Hair Regrowth Cell Therapy Update
Epibiotech EPI-001 Approval by the Ministry of Food and Drug Safety Update (12/21/2023)
As of December 21st, 2023, Epibiotech has been approved by the Ministry of Food and Drug Safety to start Phase 1/2a clinical trials for its EPI-001 autologous dermal papilla cell treatment to treat androgenetic alopecia. Safety will be measured in Phase 1 to set the maximum tolerated dose (MTD), and then the effectiveness of the treatment will be evaluated in the Phase 2a trial. Epibiotech plans to administer the treatment to the first patient in the first half of 2024, with completion expected in the second half of 2025.
Original Article
Follicle Thought presents an exclusive interview with Epibiotech CEO Dr. Jong-Hyuk Sung to discuss EPI-001 trials, other alopecia pipeline candidates, and the company’s latest business developments.
epibiotech.com
Epibiotech’s therapeutic pipeline, displayed above, represents the most diverse pipeline for hair loss or alopecia-related therapies in the world. In fact, Epibiotech is one of the only biotech companies in the world solely focused on alopecia, with multiple candidates such as cell therapies, small molecules, and antibody therapies in their pipeline.
Epibiotech Interview 2023
Currently, EPI-001 remains Epibiotech’s most interesting product candidate, and one of the most pivotal pipeline therapies in the hair growth industry. EPI-001 is an autologous dermal papilla cell therapy which involves sourcing healthy hair follicles from a patient’s scalp, then multiplying them through a proprietary culturing process, and injecting them back into the same patient’s scalp to regrow hair in balding areas. I recently got in touch with Epibiotech’s CEO Dr. Jong-Hyuk Sung to shed some light on his company’s latest developments and timelines.
Jong-Hyuk Sung PhD (cosinkorea.com)
FT: What is the latest on EPI-001? Can we expect a clinical trial to commence this year?
JHS: EPI-001 involves cell therapy using dermal papilla cells. We have conducted a nonclinical trial and are currently awaiting GMP inspection. Once we receive IND approval, we can commence Phase 1 clinical trials later this year.
FT: For greater clarity, since we are already in late Q3, is it likely for the EPI-001 trial to still commence later this year, or is it also probable that early 2024 is the start date?
JHS: Clinical application will start in this year.
FT: This month, you announced a collaboration with Samjin Pharmaceutical and unveiled EPI-007. Can you give an overview of the EPI-007 therapy?
JHS: EPI-007 is a DKK1-KO (knockout) adipose stem cell therapy. We prepared DKK1-KO ASCs and will develop them for alopecia areata (AA) treatment. Recently we found that DKK1 is highly expressed in ASCs and induced hair damage in inflammation. Especially, DKK1 is induced in AA patients and mice, and DKK1-KO ASCs are effective in treating AA. DPC is effective in androgenic alopecia (AGA), while DKK1-KO ASCs in AA.
FT: Epibiotech’s pipeline also shows EPI-002, yet we have not heard much in the news about this therapy. Can you briefly describe it?
JHS: EPI-002 is a Ripk1 inhibitor. Ripk1 is associated with necroptosis and plays a crucial role in scalp inflammation. Recently, we have discovered that Ripk1 is significantly upregulated in the hair follicles of alopecia areata patients. The overexpression of Ripk1 leads to the expression of inflammatory cytokines such as interleukins and CXCLs. Blocking Ripk1 activity has shown to reduce scalp inflammation and enhance hair regeneration. We anticipate that Ripk1 inhibitors could provide competition to Jak inhibitors in treating alopecia areata.
FT: Finally, we see Epibiotech very active in business collaborations within Asia. Yet, there are many patients interested in your therapies from around the world. Is Epibiotech exploring ways to bring their potential therapies to other parts of the world such as North America? If not yet, is Epibiotech interested in partnerships for this?
JHS: As you mentioned, we currently have partners in Japan and the Philippines, but we are currently seeking partnerships in North America as well. Epibiotech is highly interested in establishing collaborations with other countries.
Epibiotech News Discussion
After completing this interview, I noted that Epibiotech appears to research multiple therapies which may be useful in treating both alopecia areata, as well as androgenic alopecia. For example, Dr. Sung mentioned that his Ripk1 inhibitor may be a good competitor to JAK inhibitors for AA, however, the Epibiotech pipeline lists it as a therapy for AGA. Also, another candidate therapy, EPI-005, is listed as a therapy for AA, but Dr. Sung has specifically described its potential in treating both AGA and AA in media coverage.
The most important news here is that EPI-001 is on track to enter a clinical trial in 2023. There are no guarantees with projections, but even when I pressed the question twice, his answer remained confident. For perspective, it has roughly taken 13 years for a new iteration of a hair follicle cell therapy to actually enter a human clinical trial. Replicel began their phase 1 trial back in 2010, and the initial results didn’t necessarily inspire those who were seeking meaningful hair regeneration. As Epibiotech has researched and developed a proprietary cell culturing medium and process (which may involve a hypoxic environment) there is potential for a greater outcome in EPI-001 than previous cell therapy attempts. Let’s all look forward to the announcement of EPI-001 entering a phase 1 in the near future.
Special thanks to Epibiotech for the interview.
Thanks for reading. Feel free to share your thoughts on EPI-001.
Thoughts:
1) Who really cares about AA – it affects 150 per 100,000 population yet seems to have prolific clinical pipeline, perhaps it’s just a simpler condition to treat
2) What’s the difference between EPI-001 and Hairclone’s product?
Hey LJ, thanks for chiming in. I’m sure people with alopecia areata care about their condition. Yet, the majority % of Epibiotech’s efforts seem to be in AGA, so that’s good. I think years ago I thought AA got more attention than AGA, but not these days. There is a decent interest in AGA by pharma.
Your second question would have to be answered by those two CEO’s after disclosing their own proprietary processes and comparing. They are similar approaches. One main difference is that EPI-001 seems very likely to enter a clinical trial within the next 3-5 months.
Thanks FT, I get that people with AA legitimately suffer too, it just seems the amount of research targeted towards it is disproportionate, considering AGA is an order of magnitude more common….
Hairclone apparently also plans to ‘begin clinical work in 2024’….
Yes, I would be very pleased if Hairclone began clinical work in 2024, but I haven’t seen any updates which would indicate a change in their status from years past. Epibiotech is in a bit different situation having raised millions of $ in recent years. This is what makes the announcement significant in my opinion.
Hey FT as always great work! I do want to ask you though, do you think Epibiotech are spreading themselves too thin and over saturating themselves with all these different approaches and not just solely focusing on a few methods?
Thanks YoYo. I don’t think so because what I’ve seen is that typically when companies have these pipelines with early programs listed, they are barely allocating any work/resources to those projects at that time. They are usually more dedicated to their later stage projects. I like Epibiotech’s pipeline. I’ve even read in a Korean article that they are planning to release cosmetics next year, too.
Fair enough you make some valid point
It is possible to ultimate treat hair loss through breast papillocyte separation and culture technology
Epibiotech
guest reporter Cho Sung-kyung
input 2023.11.17. 03:00
update 2023.11.17. 10:51
Sung Jong-hyuk, CEO of Epibiotech. /Providing epibiotech
Can we ultimately treat hair loss? No clear answer to this question has been presented medically yet. The treatment of delaying the hair loss period or transplanting hair by taking medicine is the best at the moment.
In the midst of this, there are companies that study to enable the ultimate treatment of hair loss through “removal and culture of breast papillocytes,” drawing keen attention. It is Epibiotech (CEO Sung Jong-hyuk), which was listed on KONEX in July 2023.
Breast papillocytes are, in other words, key cells responsible for the growth of hair. Breast milk cells are the core of hair loss treatment, and so far, it has not been commercialized in the industry due to difficulties in separating and mass culture.
Epibiotech has secured both new isolation methods of breastpaste cells and technologies capable of mass culture.
Based on these technologies, a treatment is being developed to create new hair follicles and to allow hair to grow only in the desired area.
In addition, Epibiotech published the results of testing the validity of these technologies in Experimental Dermatology, an SCI international academic journal. When breastfeed cells were administered to pigs, the result of increasing the number and thickness of hair for more than three months was confirmed even with a single administration. If this technology is implemented in reality, it is expected that the injection once a year to the hair loss area will not only grow hair only in the desired area, but also dramatically reduce systemic side effects.
Called ‘EPI-001’, the treatment is currently in a complementary phase for clinical trial phase 1 approval. It is scheduled to enter phase 1 clinical trials in the second half of this year. It is predicted that commercialization will take place from 2026 to 2027, when phase 3 clinical trials are completed.
Epibiotech is also stepping up efforts to develop “EPI-005,” an antibody treatment related to hair loss. It is a treatment that neutralizes CXCL12, which increases a lot in the scalp by male hormones, and if further improved in the future, it is expected to bring major innovation to masculine hair loss treatment.
Sung Jong-hyuk, CEO of Epibiotech, said, “We will grow into a representative company related to hair loss in the future by completing additional funding to approve phase 1 clinical trials of ‘EPI-001’, a cell therapy, and proceed with nonclinical trials of ‘EPI-005’, an antibody treatment.” “We are also planning to be listed before the KOSDAQ through technology evaluation in the second half of 2024.” I said.
(So does this mean that epibiotech is going to use the (001) therapy (annually) as an injection or is it a permanent treatment i.e. (CURE). Because I personally understand that this was a “definitive” treatment for (AGA). Please clarify. Thanks ❤️
I’m speaking in general. It’s all very slow research into hair loss remedies. Most companies have a theory, but in practice there is mostly nothing.
Companies either don’t understand or don’t want to understand how to make money if they had a cure for hair loss.
Recently, a pharmaceutical company from Denmark marketed a medicine for diabetes, which turned out to be an excellent medicine for quinsy.
after that knowledge, the valuation of that company grew to 400 billion dollars or euros
It is a very good example of how much people are willing to pay for beauty.
Sorry FT one last question. What are your thought on Eirion Therapeutics? Do you think they still plan to commence their phase 1 trial for ET-02?
I would be surprised if Eirion began a phase 1 this year, but actually, it’s possible. They are an example of another company who projected to begin a trial in H1 2023, but are now pressed to get it started by year’s end. Let’s see how it goes for them.
http://m.thebell.co.kr/m/newsview.asp?svccode=00&newskey=202309051458526280105742
This sounds really interesting and hopefully they reach the funds for clinical trials. Trying not to get too excited.
Thanks for sharing, Andy. I’m not sure of the scientific background of this company YJ Lab, and their treatment sounds a bit ambiguous, but I hope it goes very well.
Thanks FT for your great work . I have a general question . can we hope for total hair grow in next year?
Amir, no I don’t think so.
Would there be any way you could find out some more about the company and the product as I agree it all sounds very ambiguous but would surely be a gold mind if what they are saying is indeed true and they could get such a product to market soon.
Andy, I don’t see that the company has a website at this time.
I emailed Stemson in July asking if there was going to be any more updates this year (as they usually give 2/3 updates per year) and they responded that that’d provide an update soon but haven’t heard anything from them since. Does anyone feel like we could potentially hear news of clinical trials perhaps starting next year?
I think Follica had an inglorious ending
Yes, for a while it became evident that the technology was only a mechanical microneedle and minoxidil. On the other hand StimuSIL seems like a reasonable substitute in the pipeline for Follica.
I think the problem was with Follica, because the device for administering the drug into the scalp had to have clinical trials and the drug.
Two separate trials.
Actually, they didn’t have separate trials because they weren’t introducing a new drug to market Luis. I think the wanting for true innovation was Follica’s biggest hurdle.
One last question on YJ lab that I shared recently they stated that they are hoping to conduct a large scale clinical trial then about commercialision for their melanin restoration technology . How long do you think that trial will last if they are going to release this to market as a cosmetic? Within a year or longer? Thanks
I would say that a large clinical trial + commercialization prep would put it over a year in almost any situation.
https://www.cosmeticsdesign-asia.com/Article/2023/09/06/korean-study-finds-that-hijiki-displays-potential-for-functional-application-to-improve-vitiligo-and-grey-hair
Another recent article from Korea about grey hair reversal and vitiligo
I think a cure for grey hairs will come before a cure for hair loss, even Eirion Therapeutics are meant for a Phase 1 clinical trial. (Unless AMP-303 is able to be commercialised by 2026/2027).
I hope both will be cured or even better treatments for both by 2030 as I suffer both in my mid 30’s. I’m optimistic that there will be, fingers crossed!