Epibiotech EPI-001 Hair Regrowth Cell Therapy Update
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治疗管道,上面显示, 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.
FT: What is the latest on EPI-001? Can we expect a clinical trial tocommence 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, sincewe are already inlate 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 therapiesfrom 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.
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 AAin 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 trialback 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.