Follicum FOL-005 MAJOR UPDATE Regarding Phase 2 Clinical Trials!
A few days ago, we received a huge update from Follicum and their topical FOL-005 treatment. Let me refresh your memory on what Follicum is doing with their FOL-005. Follicum is a Swedish company that has created a product that can both inhibit and promote hair growth. Their research is based on the human protein ostepontin and over the past few years, they have gone through several research and development, including human clinical trials with injections on human thighs which took place in 2016 and 2017. The phase I/IIa tested for safety and to see an effect of the treatment, and was successful in the sense that it did indeed show increased hair growth on the thigh. At the second lowest dosage, 76% of the treated volunteers showed a higher density of hair growth.
In 2018, the second clinical trial, they tested FOL-005 on the scalp of patients to check for efficacy and safety. The study showed that hair growth increased on average by 7 hairs per cm2 and the increase was borderline statistically significant compared to baseline. A clear positive effect was shown in the number of hairs in growth phase and at the highest dosage, there was an 11% increase in the number of hair follicles in growth phase and the ratio between the number of hairs in the growth phase to those in the dormant phase increased by 18%. So last year, they were working on the proper dosage and treatment length to optimize the maximum hair growth effect.
The last update we had from Follicum was that their hair loss product was as successful as minoxidil 5% with just 1 application a day. The result was dose dependent so we were hoping that testing higher dosages and using it for a longer period would result in better hair growth results.
So, the update from Follicum a few days ago was regarding their phase 2 study, which was approved by the German Medicines Agency and the German Ethics Committee. The study is going to comprise of 200 patients who will be treated with FOL-005 or placebo daily for the next 4 months and the purpose of this trial is to investigate the efficacy, safety and response to FOL-005 topical treatment. There will be 3 different dosages of FOL-005 so hopefully we can see a dose-dependent result and better efficacy. The study is expected to be completed and the results provided to us in Quarter 4 of this year. Apparently they have recruited 200 volunteers for the clinical trial so hopefully it will take off soon.
Now a lot of you guys are probably thinking that this really isn’t a cure for hair loss and to be honest, it isn’t. It’s not likely to reverse baldness or even be effective for those with extensive hair loss. They even compare it to minoxidil’s efficacy. However, the good news is that this may be a good replacement to those who are having side effects from using the only FDA approved topical in the US which is minoxidil. Studies confirmed that there were no adverse side effects from FOL-005 so it can be a great replacement of minoxidil. You also only need 1 application a day versus 2x for minoxidil. More studies still need to be carried out at various dosages since FOL-005 showed promising results at higher dosages, so hopefully this phase 2 clinical trial will show improvement of density and hair growth with a higher dosage.
Since Follicum is still undergoing clinical trials, it’ll be some time before commercialization, if everything is successful. They will most likely have to go through phase 3 clinical trials, go through the FDA process, manufacturing and distribution so it won’t likely be on the market for at least another 2-3 years at the earliest, but it’s good to know that we may have something lined up in the future. I always tell my viewers to stay optimistically cautious. Every now and then, I get emails from my viewers asking if they should hold off getting a hair transplant or hair loss treatment since we have better hair loss treatments in the pipeline and stem cell hair replication coming up in the near future. Here’s what I tell them. Don’t ever wait for something that isn’t promised. It’s good to see these companies like Follicum, Replicel, Dr Tsuji, Follica, etc working towards finding better treatments but the thing is it hasn’t happened now and it isn’t promised later down the road. I’m not trying to sound negative, but that’s the truth. And with hair loss, the more you delay treatment, the lower the chances of you getting your hair back. If you’re losing hair, don’t wait for anything. Get on minoxidil, get on finasteride, try microneedling or low level laser therapy. The worst thing you can do is not doing anything. You see so many people who are NW5/6/7 pushing into telling you to shave your head just because they weren’t proactive in treatment early on.
And I’m not saying anything bad about those who shave their heads. More power to you if you don’t let hair loss affect you. But the truth is, we all want hair and if we were given a choice, im pretty damn sure 99.9% of you would want to have hair. So even with these treatments in the pipeline, nothing is promised and they are all empty promises until it is proven to work, completes all clinical trials, and is available to everyone. Another thing about these stem cell hair replication is that you only need a small sample of donor hair, so there really is no point waiting. Even after getting 3-4 hair transplants, you are still going to have enough donor supply to replicate. Anyway guys, that’s all the update I have for today. If you have any questions, make sure to drop them in the comment section below!