It’s hot and very hot now in Korea. I have never expected to see 39 degree on the thermometer in my entire life in Seoul. Summer is not a season for cosmetics especially when it goes hot and steamy like this year. People rarely put on make-up, nor even use skincare in the steamy season, so the sales goes down in summer. Today, let’s turn our focus to the future after summer today. I am going to write about our new product pipeline at MEDIPOST for next seasons.
NGF-574H – Functional cosmetics for hair loss relief
Maybe some of my readers wonder what exactly the “pipeline” means in new product development. The word is used in pharmaceutical industry where it takes long to develop a new product, the new drug. The pharmaceutical industry is very tightly regulated by the authority in almost every country in the world. Sometimes it takes more than 10 years to come up with a new drug with legitimate approval after long and winding clinical trials to prove safety and efficacy. It looks like liquid flowing in the pipeline step by step slowly to develop a new drug and they call the process pipeline. It does not take that long in cosmetics industry. You may have seen an ad saying a new ingredient or new formulation that took several years and $$$ investment. Be careful though. Ad is just an ad. It usually completes within a year in cosmetics industry. On the contrary, however, it already took 4.5 years for NGF-574H, a newly developed stem cell conditioned media for hair loss to reach this far. It qualifies to be called the pipeline.
It all started in October 2013 when I was travelling in the US to attend to a stem cell conference. I had a phone call from the company to hear there’s a national research grant announced by Korean government that we need to grab a hold. I was asked to come back immediately and prepare application, which I did. Even before the grant announcement, we speculated it might be technically possible to make stem cell conditioned media optimized for specific indication by priming, and it was such a tempting opportunity that we could be financially supported to prove our hypothesis. We set up a team with Prof. B. J. Kim of CAU, one of the reputed KOL dermatologists in Korea (link to his short bio) and applied as an industry-academia joint research project to develop a primed stem cell conditioned media optimized for hair growth. We were appointed and became eligible for financial support with up to KRW 700M (U$ 700k) per annum for max 5 years. The original goal of the research was to develop a pharmaceutical product for alopecia (hair loss) with the new stem cell conditioned media but somehow changed to develop a new cosmetic product for hair loss relief in the middle.
The rationale behind NGF-574H was quite simple. If paracrine action (stem cell secrets trophic factors and physiologically influences the surrounding) of the stem cell is a response to the neighboring environment for its own survival, it would be theoretically possible that we make the stem cell conditioned media with an efficacy specifically optimized for hair growth if we expose the cell to the artificially established environment mimicking the physiology of the hair scalp in the hair loss area in advance to the secretion of the trophic factors. We call this pretreatment “priming”. The hypothesis was first proved by in vitro study with derma pappilar cell line (DP cells) derived from the human hair scalp. The primed conditioned media showed much enhanced effects on the proliferation of the DP cells compared with naïve conditioned media without priming. Secondly it was also tested with the hair follicles extracted from human volunteers by biopsy. Treatment with the primed media resulted in 150% improvement in the hair growth in the follicles compared with the naïve one. Alopecia is notorious for the lack of correlation between clinical efficacy in human and ex vivo or in vitro study. It is well known in the academic community that you cannot be sure of the efficacy until it is proved in human. More than thousands promising candidate molecules proved effective in the lab turned out to be a failure in human. Human clinical study is expensive, but the financial support by the grant helped to give it a try.
The clinical trial was designed as an IRB approved placebo-controlled double blind study with 30 female and males subjects diagnosed androgenic alopecia (IRB is a short for Internal Review Board at the clinical site, usually a hospital, to make sure the trial protocol is in compliance with ethical guideline, and double blind means neither investigator and subject know who belongs to test group or control group to avoid bias). The subjects were assigned randomly either to the “test group” where a hair essence product containing 5% of NGF-574H as an active ingredients would be used or to the “control group” where the same formulation without the active ingredients were used as a placebo. The subjects are required to use the product once daily every day for total 16 weeks and were asked to visit the site at the 4th, 8th and 16th week for assessment during the trial. Data analysis were done at the end of the 16th week to see statistical difference in hair density, hair diameter (thickness) and hair growth rate between the test group and the control group and also between the assessment time and baseline (assessment measure at the beginning of the study, week 0). The outcome was surprising. The test group showed a significant difference from the week 8, and final analysis after week 16 confirmed statistically significant difference in hair density, diameter and growth rate, respectively. Compared with the baseline, hair density increased by 14.4% and hair diameter by 28.2%. For your comparison, a clinical study with Rogaine (link), one of the most widely used hair loss medicine, has it that the improvement in hair density is by 8.8% compared with baseline after 48weeks of usage twice daily (ref). Recently, follclethought.com, one of the most popular blogs on hair loss and growth, covered our NGF-574H story (link).
Hair loss or alopecia has been known for long as a men’s syndrome, but nowadays many female patients are suffering from the same(News link). Woman rarely goes to the full blown baldness but, given higher sensitivity to the appearance, female patients would suffer more from the hair loss even at the milder symptom. The regulatory category of hair loss relief product was changed from quasi-drug to functional cosmetic in Korea, and we are in the process of registration to MFDS (Korean FDA) as a functional cosmetics pursuant to newly established guideline. If all goes as planned, we expect to launch the product in 4Q this year or 1Q next year after registration. I do hope the new product will be a relief to the female patients suffering from lack of effective treatment that can be easily purchased in the market.