[Daejeon, Republic of Korea – January 2, 2020] BIONEER announced that it has made an application for permission to the Ministry of Food and Drug Safety (MFDS) in Korea for candidate materials of functional cosmetics capable of alleviating hair loss, as those have shown excellent results during its clinical study.
Bioneer conducted a 24-week clinical trial on male and female patients diagnosed with androgenetic alopecia to be tested with 'COSMERNA', a highly efficient product containing siRNA applied with SAMIRNA ™, the next-generation RNAi therapeutic platform technology from Bioneer.
Quantitative analysis using phototrichogram technique showed that the total number of hairs in the test group, the ones that have used COSMERNA three times per week, showed an increase at week 16 and 24, while the total number of hairs for the control group showed a decrease. Comparing with the pre-test results, significant differences were shown after 16 weeks, and the gaps became more predominant over the time of the test.
The participants of the clinical study were also showed positive opinions during the survey.
In the part of the questionnaire asking about the thoughts on the efficiency, the test group answered positively on 'enriched hair', 'enriched hair loss area' and 'reduced hair loss' parts.
The mechanism of BIONEER’s candidate materials works by inhibiting the production of androgen receptors (AR), which attach with dihydrotestosterone (DHT) and induce hair loss. By reducing the number of androgen receptors, the side effect can also be drastically reduced compared with conventional hair-loss medications.
The successive results of this clinical study have shown that BIONEER’s candidate materials are effective in hair-loss caused by overexpression of androgen receptor or by the conversion of testosterone to DHT. With this, the development of Alopecia Areata therapeutics using SAMiRNA™ technology, also being currently under development, is expected to gain momentum.
While obtaining approval of functional cosmetics from the MFDS, BIONEER is also preparing to commercialize various products according to its plan.
Bioneer said “this is the first time to demonstrate the efficiency of our next-generation siRNA technology, SAMiRNA™, which is known to overcome the side effect of the innate immune response from the traditional siRNA therapies. This means a lot to us. We are going to be first in the world to release medications to alleviate hair-loss using our own, patented next-generation siRNA technologies, and open up a new era in functional cosmetics.” Bioneer also added, “with these results, we can accelerate the development of our ongoing new drug therapeutics pipelines using SAMiRNA™”.
COSMERNA’s safety was approved with the strict skin test, showing no irritation or any other symptoms, approved by gaining local patents, applying for PCT, and being registered on International Cosmetic Ingredient Dictionary and Handbook (ICID) and Korean Cosmetic Association (KCA) as a candidate material for functional cosmetics.
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About BIONEER Corporation
Established in 1992, BIONEER is the first Korean biotechnology company aiming for the complete localization of genetic technologies. It is also the first in Korea to develop and commercialize enzymes for PCR, oligos, primers, and real-time PCR instruments. With its continuous research and development, BIONEER has focused on supplying instruments and chemicals for researchers in the field of biotechnology and providing various services such as sequencing, NGS, gene/protein synthesis, and gene expression analysis. Thanks to those endeavors, BIONEER has acquired deep expertise in genetic technology to expand its field of business to molecular diagnosis and new RNAi drug development.
How phototrichogram analysis has been done
Shave the target area of the hair equally not exceeding 1 ㎠, then take the magnified photograph of the region for a fixed period and count the total number of hair. Analyze the data by comparing it with the results taken before and after the clinical trial.