Category Archives: siRNA

Sirnagen CosmeRNA for Hair Loss: Releasing in 2023

CosmeRNA Hair Loss
CosmeRNA for hair loss. The solution will come in 6ml dose bottles.

South Korea just keeps on adding groundbreaking companies working on new hair loss treatments. The latest of these is Bioneer’s siRNA based cosmeceutical called CosmeRNA that targets the androgen receptor. It was released in Western Europe in May 2023. Note that the top half of this post is all updates.

Update: May 2, 2023

  • CosmeRNA online shop is now open! The price is €300 ($330) per bottle (vial), higher than originally expected. However, per the company’s site, it seems like the frequency of application will be reduced once all the androgen receptors are inhibited. Initially, the treatment is applied topically every two weeks for the first four months. Afterwards, once a month application may be sufficient to maintain the fuller hair.

Besides the key siRNA technology, the other ingredients are listed as follows:

Aqua, Phosphate Buffered Saline, Alcohol, Butylene Glycol, Betaine, Niacinamide, Stearyldisulfidehexyl DNA-2-PED-45/SH-RNA-1, Panthenol, Menthol, Sodium, Biotin, Citric Acid.

— It looks like Bioneer’s CosmeRNA Mall will finally open tomorrow. They describe the product as:

“The world’s first hair loss relief cosmetic based on RNA technology.”

CosmeRNA Finally Releasing in May 2023

Thanks to “Mathis” for the weekly updates. CosmeRNA’s slightly delayed release date is now confirmed for May 2023 per various news articles. Bioneer aims to get 100 million users within 5 years per CEO Park Han-oh. Release of the product in South Korea has been delayed due to some legal issues, although there is a lot of demand in the country.

The below YouTuber managed to contact a Bioneer employee and estimates the cost to be $67 per month. Based on a single $200 priced 6ml bottle lasting for three months, with 1ml recommended usage every two weeks. For comparison, the best laser hair growth devices cost $1000 or more, although the Lasercomb is much cheaper.

New CosmeRNA video:

February 22, 2023

CosmeRNA for Sale at the end of March 2023

CosmeRNA related news just keeps coming and seems very encouraging. In the latest article from South Korean media, the company makes some bold claims:

  1. They expect sales of up to 160 billion Won (i.e., $123 million). This is quite extraordinary for a new cosmeceutical hair loss product that will only be sold in one region (Western Europe) for the time being.
  2. They state that “when the shopping mall opens at the end of next month, we will start full-fledged sales for European buyers.” So the product will be on sale by the end of March 2023.
  3. Since siRNA is mainly used for research, very few facilities have mass production capabilities. The scale of siRNA synthesis for most studies is at the mg level. Per this latest news, Bioneer can produce raw materials at a level of 1kg to 1.5kg per month,
  4. There are no major side effects and the product application does not leave any sticky residue.

Note that earlier this month, Bioneer announced that it will even sell on Amazon. And they will be partnering with Ace Biome for marketing and distribution purposes.

Registration on CPNP and SCPN Cosmetic Product Notification Portals

February 2, 2023 — Yet more encouraging news. Bioneer has also completed product registration with Britain’s submit a cosmetic product notification (SCPN) portal. Moreover, in January it participated in “IMCAS World Congress 2023” in France. this was in order to introduce Cosmerna to buyers around the world and to secure a distribution network.

December 26, 2022 — Bioneer announced that it has completed the registration of CosmeRNA on the cosmetic products notification portal (CPNP). The latter is a European cosmetics certification system and means that Bioneer can now distribute CosmeRNA throughout the EU.

November 23, 2022

CosmeRNA from Sirnagen (Bioneer) Releasing in 2023

This post covers a new topical hair loss product called CosmeRNA, whose website is now live. It is made by siRNAgen (South Korea), a subsidiary of Bioneer (South Korea). I briefly covered this company in the past, but now it deserves its own post.

The reason I am writing this post is due to a great new interview with siRNAgen CEO Dr. June Park. Both these new developments were sent to me by a reader who wishes to remain anonymous. Key quote from Dr. Park (also see her Linkedin):

“The first SAMiRNA product will be available for sale in the first half of 2023. We had an unconventional route to commercialization by developing a hair loss cosmeceutical product. CosmeRNA, named after cosmetic RNA, provided an early validation of our platform’s potential as a topical cosmetic product for androgenetic alopecia (hair loss).”

They will not need to conduct clinical trials since this is a cosmetic product! The actual release date is likely to be in early 2023 per another quote in the same interview. After first being done in South Korea, CosmeRNA’s safety study was repeated in Europe by Dermatest in 2022. Note that SAMiRNA is shelf stable in a solution for a year, so it can be applied topically.

Ms. Park anticipates the product launch to occur some time in early 2023. They will focus on the European market first due to the region’s more streamlined cosmeceutical trial and approval process. Via the Cosmetics Product Notification Portal (CPNP).

Note that I previously briefly covered siRNAgen Therapeutics in my post on OliX Pharmaceuticals. The latter is working on a hair loss cure involving RNA interference (RNAi) via asiRNA (asymmetric small interfering RNA). The aim is to reduce androgen receptor (AR) expression on the scalp.

SAMiRNA, Androgen Receptor and Hair Growth

Like OliX, siRNAgen is also working on reducing AR expression and re-growing hair. However, it is doing so via treatment with self-assembled micelle inhibitory RNA (SAMiRNA) nanoparticle-type siRNA. See their site for more on small interfering RNAs (siRNA).

They published an important study on this in Nature Journal in January 2022. The encouraging title of this paper is worth posting: “Weekly treatment with SAMiRNA targeting the androgen receptor ameliorates androgenetic alopecia.”

The product they use for androgenetic alopecia is a topical called AR68. It is classified as a cosmetic ingredient and will be called Cosmerna-68. In the above mentioned paper, they have before and after photos of a patient that I pasted below. The chart on the right shows the actual percent improvement with AR68 0.5mg/ml treatment versus placebo. They also state the following:

“In the low-dose (0.5 mg/ml) clinical study, AR68 was applied three times per week for 24 weeks, and through quantitative analysis using a phototrichogram, we confirmed increases in total hair counts. In the 24-week long high-dose (5 mg/ml) clinical study, AR68 showed average additional hair growth of 1.3-1.9 hairs/cm2 per month, which is comparable to finasteride. No side effects were observed. Therefore, SAMiRNA targeting AR mRNA is a potential novel topical treatment for AGA.”

0.5 mg/ml AR68 (3x a week) Before and After

Sirnagen CosmeRNA AR68
Sirnagen CosmeRNA SAMiRNA AR68 0.5mg/ml hair loss treatment (3X per week). Source: Yun, SI., Lee, SK., Goh, EA., et al. Sci Rep 12, 1607 (2022).

5 mg/ml AR68 (1x a week) Before and After

The higher dose AR68 5mg/ml before and after photos are here. The researchers claim that these results at 24 weeks are comparable to those from Finasteride.

Sirnagen AR68 5mg per ml Hair Growth.
Sirnagen CosmeRNA SAMiRNA AR68 5mg/ml hair loss treatment (1X per week). Source: Yun, SI., Lee, SK., Goh, EA., et al. Sci Rep 12, 1607 (2022).

Summary

Is this a miracle? Most likely not for most severely balding people people. However, just as with finasteride, some people could see stellar results. And for those who only recently started to go bald, this could be a much needed non-DHT inhibiting product. With few if any side effects.

I am not a big believer in cosmetics, but this latest interview with siRNAgen CEO June Park is encouraging. She comes across as very intelligent and sincere. Note that in Bioneer’s September 2021 presentation, they describe CosmeRNA as a game changer hair loss treatment. It will have no side effect issues such as those seen with Finasteride (Propecia).

OliX Pharmaceuticals RNAi Hair Growth Trials in 2023

In 2021, I wrote a post on microRNA (miRNA) and hair growth. In there, I also discussed a new company working on messenger RNA (mRNA) based hair regeneration. And now we have RNA interference (RNAi) as a hair loss treatment, thanks to OliX Pharmaceuticals (South Korea) and its small interfering RNA (siRNA) based product.

Also not to forget, most recently, we have become excited by CosmeRNA, a SAMiRNA based hair loss treatment that targets the androgen receptor. SAMiRNA is a new type of siRNA nanoparticle that does not result in innate immune stimulation. The number of different acronyms containing “RNA” that are being developed for hair loss treatments is mind boggling.

Update: March 10, 2023

Olix Pharmaceuticals Clinical Trials

OliX just got approval from Australia’s Human Research Ethics Committees (HREC) to begin a phase 1 clinical trial of OLX72021. This candidate “inhibits the activity of hormones that cause male hair loss”. The effect lasted for more than three weeks in animal tests.

Update: In a March 23 article on this same development, CEO Dong Ki Lee states the following:

“We are also planning to launch hair loss cosmeceuticals in due time for the safety of OLX72021 to be confirmed in this clinical trial.”

So far, we have only heard about Olix’s RNAi based candidate for the treatment of male pattern hair called OLX104C. It reduces the expression of the androgen receptor via small interfering RNA (siRNA). Neither of these products is as yet listed on the company’s pipeline page. Perhaps the new product is just the old one renamed. I will update this post when I find out.

Asymmetric siRNA Targeting  of the Androgen Receptors

On November 22, 2022, OliX published preclinical research on its androgenetic alopecia treatment program, OLX104C. The results are very encouraging. Actual study is here and the researchers demonstrated:

“Efficacy of androgen receptor (AR) reduction, hair loss inhibition, and long duration of action in primary cultured human follicle dermal papilla cells (HFDPC) and rodent models of hair loss.”

They call this technology “cp-asiRNA targeting AR” and “AR-targeting asiRNA (cp-asiAR)”. The asiRNA stands for asymmetric small interfering RNA.

Olix siRNA Hair Growth
Olix siRNA Hair Growth. Source: Molecular Pharmaceutics.

In May 2022, OliX raised $45 million and announce that its androgenetic alopecia product (OLX104C) will enter clinical trials later this year. Moreover, in August 2021, OliX obtained a Notice of Allowance from the US Patent and Trademark Office for OLX104C.

In June 2021, OliX signed an agreement with LGC Biosearch Technologies to accelerate production of asymmetric siRNA for the treatment of androgenic alopecia. Olix CEO Dong-ki Lee also presented at SMi’s 12th Annual RNA Therapeutics virtual conference.

OliX Pharma’s RNAi Hair Loss Product OLX104C

OliX Pharmaceuticals (South Korea) just made a major announcement. Their RNAi based hair loss product OLX104C successfully grew back hair in mice following just one single injection. The mice were suffering from androgenetic alopecia due to them being given excess dihydrotestosterone (DHT).

“We are advancing a novel and potentially durable approach to treating hair loss” — CEO Dong Ki Lee

OliX Pharmaceuticals RNAi Hair
OliX Pharmaceuticals and its RNAi product OLX104C. Before and after hair growth in mice.

In this preclinical study, OLX104C was administered topically to a mouse model via an injection. The before and after photos are amazing. Interestingly, they compare the results to the anti-androgen Flutamide.

More importantly, OliX is the real deal. Their news page is very impressive with regular significant developments. This includes raising $37.2 million in December 2020. They also received US FDA Phase 2a approval in November, 2020 to treat hypertrophic scars.

siRNA

On OliX’s pipeline page, they state that small interfering RNA (siRNA) has limitations in terms of stability, delivery and toxicity. This is not a problem with RNAi therapeutics. Edit: Per the patent, they are using asymmetric siRNA to inhibit male pattern hair loss gene expression.

Hundreds of millions of people around the world took mRNA vaccines during the past few years. Even thought they did not go through rigorous clinical trials for five plus years. In effect, this will speed up scientific progress. Many people will no longer worry about long-term side effects for newer such RNA related drug candidates. Perhaps a mistake, but I will not complain too much if it speeds up the realization of a hair loss cure.