Birch BioMed: Therapies for Scarring & Alopecia Areata

I’m pleased to share with you all a startup which is a little bit “outside the box” from the usual companies you’d see on Follicle Thought. Today’s topic of interest, Birch BioMed, is based in Vancouver, Canada and was birthed on the campus of the University of British Columbia. The company’s prize clinical candidate is a novel drug which prevents scarring on a molecular level and also breaks down existing scars. Couple that with a therapeutic platform targeting auto-immune diseases and you’ve got quite an interesting biotech company to read about.

FS2 For Scars

Birch’s lead therapy is an anti-scarring technology called FS2. Originally dubbed “Fibrostop”, FS2 is derived from a metabolite called kynurenine. The team at Birch, lead by CSO Ryan Hartwell PhD, made the discovery for FS2 after contemplating an interesting and obscure facet of human pregnancy – fetuses heal without scars. After delving into the research, several antifibrotic (antiscarring) agents were discovered, and the most efficacious of them was FS2.  

FS2 has already completed a phase 1 safety trial in Canada, and is set to enter phase 2 trials in the US and Canada. The company believes FS2 will be useful in multiple forms of scarring including scars from burns, keloid scars, and surgical scars. What’s even more interesting, FS2 is being touted as a therapy to “breakdown existing scars.” At this stage, the drug’s potential of efficacy is not clearly defined. For example, it’s not clear whether FS2 can erase 90% of the appearance of a scar, or only 40%. That will be precisely what everyone will be looking to find out during the imminent phase 2 clinical trials.

From the South Beach Symposium Presentation

For more background on FS2 please visit the following links:
Audio Interview with Ryan Hartwell PhD – Fibrostop
South Beach Symposium Presentation Ryan Hartwell Phd

Auto-Immune Applications

The Birch team has also embarked upon research for treating auto-immune diseases, including type 1 diabetes and alopecia areata. Birch’s auto-immune platform technology is called AI-001 and involves the oral administration of FS2 along with an injection of allogeneic cells. By definition, allogeneic cells are cells which have come from a separate entity of the same species; not from a patient’s own self. Amniotic cells or umbilical cord blood cells represent types of cells which could be used in this application. Mark Miller, CEO of Birch, has described this therapy in greater detail during a recent interview:

“While our antifibrotic therapeutic, FS2, works at the molecular level to stop the formation of scars, it also has been effective, when administered in combination with cell therapy, in reversing certain autoimmune diseases, as previously mentioned. In effect, when we inject allogeneic cells in combination with FS2 into a subject in the throes of an autoimmune reaction, the subject’s autoimmune system essentially redirects its focus. In the case of Type I diabetes, the autoimmune system is attacking the subject’s pancreas and – ultimately – the pancreas’ ability to produce insulin. While the autoimmune system erroneously reacts to the body’s pancreas as foreign, it ultimately reacts to the allogeneic cells as even more foreign. It begins to attack the alien cells and encounters our therapeutic, FS2, which was co-administered with the alien cells, and essentially resets itself.”

In the same interview, Miller noted that the cell therapy combination also lead to the complete reversal of alopecia areata in mice which were bred to have the disease. Birch BioMed has received a grant from the National Alopecia Areata Foundation for its research. As Birch continues its R&D in this space there is currently no clinical trial is set for alopecia areata.

Commentary

There are multiple avenues of relevance between Birch’s therapies and this audience. The most obvious, of course, is a therapy for alopecia areata. However, also intriguing is the potential for the anti-scarring therapy to be useful for those who have – drum roll please – underwent hair transplant surgeries. We will have to wait for clinical results to understand the full potential of FS2, but imagine if this drug could reduce the appearance of a FUT scar by 50%. Combining that with scalp micropigmentation tattoos to camoflage scars and grafting follicles into the scar via FUE represents a potential solution for virtually anyone dealing with hair transplant scars. I’d like to hear commentary about this application from Birch in the future.

For those of you who are wondering if Birch’s AI-001 therapy might be useful for common hair loss, it seems highly unlikely as the therapy is designed to address auto-immune diseases. All in all, Birch BioMed has some very interesting therapeutics in its pipeline, we wish them great success.