Moogene Medi: HUTERA Sonicated Topical Dutasteride & OliX Pharma Trial
Moogene Medi of Korea shares an update on their topical anti-DHT therapies utilizing microbubble delivery and ultrasound technology with limited systemic exposure.
HUTERA Hair Loss Treatment
In November 2020, Follicle Thought introduced Moogene Medi as the first company officially working on a CRISPR gene editing therapy for hair loss. Over a year and a half later, Moogene’s program for hair has progressed, however, its approach using CRISPR has temporarily taken a back seat for more conventional approaches. On May 2, 2022, Moogene aka Mujinmedi shared a detailed post through its official blog on HUTERA, a new advanced topical dutasteride treatment. Moogene always considered the option of utilizing existing hair drugs in its proprietary delivery system as mentioned in my original article, and for regulatory reasons it has decided to pursue those first.
The novelty of Moogene’s approach to hair therapies is found in its delivery system. Whether using CRISPR Cas9 RNA or dutasteride/finasteride, the delivery mechanism is as follows: an active pharmaceutical ingredient (API) is loaded into lipid nanoparticles (LNPs), these nanoparticles are attached to a microbubble, the microbubbles are formulated in a topical solution which is applied to the skin, ultrasound frequency is administered to the solution which bursts the microbubbles and creates temporary micropores in the skin and delivers the active ingredient LNPs into the dermis. This technique is referred to as sonoporation. Moogene claims that an advantage of this system is an improved delivery of APIs to the dermal layer/dermal papilla of the hair follicle.
Moogene’s recent blog post shared some impressive results regarding drug delivery and limitation of systemic exposure, albeit in a rat model. Below, in the graph on the left, the blue bar represents the amount of dutasteride delivered to the epidermal layer, while the orange bar represents the amount delivered to the deeper dermal layer. You will notice that HUTERA with ultrasound delivers around 20x the amount of dutasteride to the dermis, compared to a topical ethyl alcohol solution. The chart on the right depicts blood concentration levels of dutasteride after application. HUTERA with ultrasound accounts for less than 1% of the serum levels compared to oral dutasteride, however it is slightly more prevalent than the simple topical dutasteride in ethyl alcohol.
blog.naver.com/moogene2
Q&A With Moogene Medi
Below are responses from two discussions with representatives of Moogene, including Director Samuel Kim and CEO Prof. TJ Yoon.
FT: What’s the status of the CRISPR therapy and when will a study of HUTERA begin?
MM: We are prepared to complete a human study of HUTERA in H1 2023, not CRISPRA Cas9 therapy. In the case of CRISPR Cas9 therapy, commercialization is being delayed according to Korean Laws and regulations about gene therapy. In Korea, the law restricts gene therapy research to only incurable diseases such as genetic diseases, cancer and AIDS etc., so we are looking for a way to commercialize it now.
MM: Yes, we are looking for strategic partners for global sales and commercialize, but now we’re focusing on the Korean FDA approval of HUTERA firstly.
FT: If HUTERA is a doctor’s office-based procedure, how frequently do patients need to receive treatments?
MM: The dosage and usage can be confirmed only after the phase 2 clinical trial is completed. However, we anticipate that only once a week treatment will be sufficient through non-clinical testing. Currently, it is most desirable to treat it in a hospital, but we are in the process of getting Korean FDA approval in a form that patients can treat themselves at home.
FT: If a trial goes successfully for HUTERA in 2023, do you have an estimate for long how it could take to become approved for Korean patients?
MM: It is expected that it will take at least 6 months or more from phase 1 clinical trial to phase 3 clinical trial. It is expected that sales for patients will be possible after the phase 2 clinical trial is completed. As you know, conventional drug discovery takes a very long time. However, our HUTERA is an improved new drug. Therefore, the development period is short. Clinical trials may be lengthy depending on the progress, but in the case of topical treatment, the clinical trial period is short. (editor’s note: Moogene’s blog mentions H2 2023 as a target for release.)
OliX Pharmaceuticals Raises Capital, Prepares For Androgenic Alopecia Human Trial
Yesterday, OliX Pharmaceuticals of Korea, a company developing small interfering RNA therapeutics, announced it raised $45M USD. The funds will be used to support OliX’s research & development programs according to its press release. Also mentioned was plans to begin a clinical trial for OLX104C, an androgenic alopecia therapy, this year in 2022. As a therapy which targets the androgen receptor, it may be suitable for both men and women. It should be noted for some readers that press releases are intended to present ambitious and attractive information, it is wise to keep expectations tempered. As always, schedules are subject to change. With that said, $45M is quite an advantageous amount for a company looking to fund clinical trials.
Posted in Hair Growth Treatment, Moogene Medi, OliX Pharmaceuticals
Apparently, the plan is for HUTERA to be an at-home treatment. What do you think of the prospect of HUTERA?
After carefully examining the serum chart, I believe it may have the same potential for side effects as topical dut/fin, but will likely have a marked efficacy improvement.
HUTERA seems like if it comes out it will be good to add to a stack with pyrilutamide.
Is the duta in ethanol is the topical dutasteride control group.
Skye, it was hard to decipher your question (and if it was a question) but anyways, yes dutasteride was administered to the rats orally, topically with ethyl alcohol, with HUTERA -ultrasound, and with HUTERA + ultrsound (which is actually true HUTERA), and compared respectively.
Did they mention the expected costs (per month) for this treatment? What do you think?
Unfortunately I have no idea at the moment and I will wait before asking. Typically, I think they don’t know hard prices until they’re getting ready for a rollout. However, I think a reasonable answer is “affordable for anyone who really cares about hair loss/growth.”
Great, thank you! … The very short timeline from Phase 1 to Phase 3 is amazing. The interesting thing would be when could it come to market in Europe and US? And of course before after pics.
We would like to know more news about hair cloning, when it will become available and what are the latest developments because I believe
It may be the last solution to hereditary baldness problems.
Evan, when news is available I’m happy to share it with everyone. There’s a multitude of articles in the past for you to peruse using the Search function within this site. Look at Stemson, Tsuji, Epibiotech, TissUse, etc. Also, make sure to look over the Ultimate Guide to Hair Regeneration article. I try to maintain it the best I can in my schedule, all in all it is a solid reference list.
Okay
Just one last question, I would like to know what is the closest treatment to the release date
Thank you for your efforts.
Straight off the Ultimate Guide to Hair Regeneration’s pipeline chart I can tell that Kintor’s KX-826, Shiseido RCH-01, and HairClone are the three treatments closest to potential release. Now, you’d have to do a bit of reading to understand the background of each of these companies.
To summarize: KX-826 aka pyrilutamide from Kintor Pharma is the most solid prospect of those three. It should be on a smooth development path. Next, HairClone would be able to reach customers in the UK through a regulatory technicality within months yet they tend to be challenged by fundraising hurdles. Shiseido is currently trialing multiple injections of RCH-01 to see if it will finally be worthwhile and they are also in a legal dispute with the owner of the technology. So, a company who has a projected release a few years later may actually seem more likely/promising than Shiseido due to their storyline. You kind of need to have an understanding of things to form an opinion. That’s it in a nutshell. Please feel free to do further reading for your information and thanks for visiting. If you have other questions, fellow readers can also help.
Can you elaborate what the fundraising challenge is? If kx-826 shows any real promise, VC will throw as much money at them as they could possible ever want.
baldasian, I edited my comment so it is easier to understand.
KX-826 aka pyrilutamide has all of the funding it needs. It is HairClone which has the funding challenges. Many VCs would fund them after they see results from an initial study, but few want to be the ones who fund the initial study.
I have to wonder why did they even test using CRISPR They have had to know what the regulations were before experimenting. I mean it’s really interesting and positive that they would experiment using CRISPR but They teased us. Anyways I wonder how many ultrasound treatments with dut or fin you need to do to halt AGA.
True Woofy, sounds like they wanted to tease the crowd with some buzzwords (‚crispr‘‚gene-editing‘).
They state that CRISPR-therapies are limited to more serious diseases, at the very same time Olix (from Korea too!) announces a trial for their gene-therapy? Confusing.
Anyhow, Hutera sounds like a slightly superior alternative to existing therapies. I‘m cautiously optimistic, if the timeline holds and it’s an at-home-treatment.
@admin: why do you think Hutera has the same potential for side-effects? I don’t see that when reading the charts.
Ben I believe it has the same potential for side effects as topical dut, this is simply because the serum levels were the same and ever so slightly higher for HUTERA of course. Compared to oral, yes the potentials are much lower.
And by the way OliX is not using CRISPR.
Oh I see you compared topical Dut vs. Hutera. Yes very similar results, but imho it’s decisive to compare with oral Dut, and there’s the main difference.
Regarding Olix they use RNAi, that’s right. But your interviewee uses the term „gene therapy“ which includes RNAi if you ask me.
„RNAi and CRISPR interrogate gene function by blocking gene expression and analyzing its effect on phenotype. RNAi silences genes by generating knockdowns at the mRNA level, while CRISPR generates knockouts at the DNA level“
We’re in the same boat Ben. I think HUTERA is quite interesting and I am in favor of Moogene trialing the CRISPR version. Apparently the Korean FDA is more comfortable with RNAi therapies at this time. Perhaps even the US is a better location for Moogene to persue for CRISPR.
Hey did you see this? FDA approved Eli Lilly with a rheumatoid medication for alopecia?
https://www.nytimes.com/2022/06/13/health/alopecia-drug-approved-fda.html?smtyp=cur&smid=fb-nytimes&fbclid=IwAR0qmDJB-0CohDjsNDYI_XMS13QS1dyGhZDVAGZVqNz1H59nL0lrRnuaZlw&fs=e&s=cl
nevermind I see you asked that question FT. Thanks. Didn’t see it. Late at night eyes need rest lol 😆
This new delivery system sounds very interesting indeed. Thanks for posting the q&a you did FT. Looking forward to Kintors reveal of phase 2 results next month
Thank you Kahuna.
hello admin, by any chance, do you know at which Congress will Kintor present its phase 2 results for KX-826 next month?
if the answer is NO, please could you investigate? I’d like to go to the Congress if possible. thanks .
I don’t know gipsy. I’ve tried to taking a look and would appreciate any suggestions from the audience about which conference this could be as well.
Is Tsuji Hair cloning dead?
I wouldn’t say it’s dead, but it’s quite stagnant. Last we heard from him was in 2021 asking for donations via Twitter. I suppose, there’s always the possibility of some business approaching him to fund him, but that seems less likely now with more competition popping up all the time.
What about. Dr. Fukuda
And I heard news that the launch date is
Next year
Is that correct ?
I also heard that there are human trials at the present time in France
Is that true or not ?
I have never heard any of this joooy, can you please share a link here or reach out on the Contact page?
Absolutely this kintor delay is due to covid. China had been delaying all sorts of gatherings. Literally every event in China is postponed.
Glad to see you guys with an optimistic view and chiming in. You may be right, we’ll have to see in Sept. I still think it’s an unusual decision to wait that long, but only Kintor knows the whole story. We at least know they were confident enough to fund a phase 3 trial in China already which bodes well for the drug.
Thanks to Mathis for the heads up, it appears that the dermatology conference where the KX-826 phase 2 results were set to be presented has been postponed until September. Further details on the https://folliclethought.com/updates/ page. I’ve adjusted my personal expectations a bit.
I believe the postpone is due to the multiple lockdowns in China. I doubt it has anything to do with poor results.
So if Kintor KX-826 is a flop which is looking increasingly likely, are there any other promising treatments to look forward to this year? I’m getting the feeling it’s going to be 2025 and there will still just be finasteride and minoxidil as the best androgenetic alopecia treatments the way things are going.
Are you referring to clinical trials this year or drug approvals? I’m sure you’ve seen the Ultimate Guide article. Technoderma may potentially enter a phase 2 and Hope Medicine could also start their international phase 2 which likely includes the US, Epibiotech has plans for a cell therapy trial and even OliX may start trials this year (per this article).
Follicle Thought,
I understand that the Kintor results being pushed back is disappointing, but now you seem really down on it. Didn’t you write that the event that the results were supposed to be presented at was delayed due to Covid? I don’t see why that leads you to believe we should adjust our expectations. Am I understanding you correctly?
I’m not intending to be overly down on it, Mr. Burns. I just can’t quite comprehend how a company would let their results presentation wait a whole year. I can understand waiting until June, but September? Also, people seemed to be quite high on pyrilutamide over the past 1.5 years, and I thought very highly of the company’s speed of progress, so I’m simply keeping things in check. I’m not saying to expect a failure, I’m offering an admonishment to avoid overestimating the drug, due to this odd behavior by Kintor. Someone like you probably already has a healthy perspective for pyril and does not need any advice, but for others without practical expectations, if pyril turns out to not be a big winner they will act shell shocked. I will rephrase my update sentence so it’s not as confusing.
I’m just assuming announcing at big conferences over more to the business than letting the public know whenever they can.
Doubt it’s something to worry about too much, seems to be a result of China’s COVID restrictions than them thinking the results aren’t good enough
Skye, that’s the great thing about future trials/results/companies they can always turn out very good or better than we were expecting. Just have to wait till September to find out.
FT,
Yeah that’s fair. I think I see what you’re getting at. I think they can release the data whenever they want, so there is probably some reason other than the delay of this event why they aren’t releasing it. Thanks for the explanation.
Regardless of the effectiveness of Kintor, they will release the drug, that is, if the safety protocol is passed.
The results of phase 3 may be announced in September
It is perhaps the only company in the world that thinks about the economy or the profit from the sale of drugs. While other companies are very strange.
They are looking for money, investment and their results are years away.
I was just reading thru some recent hair loss articles and twice I read that hair regeneration is at least 10-20 years away according to some scientists in the industry. So there goes all my hope.
It’s going to come down to money and effort. Yes, if you ask Dr. Terskikh (founder of a hair cloning company), Dr. Cotsarelis, or some academic researcher you will get different opinions on timelines.
That’s seems really pessimistic, even looking at the Ultimate Guide to Hair Regeneration, it looks like 5-10 years is a better estimate.
Sooner depending on Kintor (2023) or Hairclone (2022?)
Though Hairclone hasn’t given any results, (Not sure if there’s an update there) Kintor has been moving through clinical stages even if they haven’t been as consistent with releasing the results they’re still progressing quickly.
Figured I’d look into Hairclone, since they have that 2022 date for release.
I found in their website that they will be giving a conference.
“CEO of HairClone, will be presenting to delegates at the Facial Aesthetic Conference and Exhibition (FACE) taking place from 17th-18th”
Not sure if they’ll give a progress update, but something to keep an eye on
I would think the presentation is more geared towards attracting investors, but I will keep an eye on it, thanks Falcon.
Can you pls contact sirnagen , derma test or bioneer about cosmerna they have in their pipeline that they are releasing as a cosmetic in Eu
Frank, you’ll be pleased to hear that I am in touch with siRNAgen and will be able to share some of the first news about the product when news becomes available. The plans for now are a launch in early in Europe in 2023.
Are you interested in the product, would you buy it when available?
Hey Admin.
I’d buy it if it’s available.
Would you be able to ask if they count UK/Ireland as Europe or if they’re just targeting EU countries?
Post Brexit it’s hard to figure what’s coming to NI
Yes I would buy it of course so you are in touch with them but can’t share with us more info . Are they doing more trials is it passing as a cosmetic?
Skye: I will certainly ask for you when I get the chance.
Dan: Yes, I’m in touch but there’s really not anything besides what I’ve said to be shared. I’m waiting for more info just like most of you. The last I read in a news article update they were doing a Euro study and aiming for a 5 star rating in safety from a reviewing agency which would prepare for their launch in early 2023. I will be glad to fill you all in with more details when they are confirmed, hopefully within the next few months.
What about that Indian, the scientist looks like an Indian
which spoke of mitochondria being cosmetics
Yuva Biosciences, yes they have a compound which has been tested in hair follicles in a dish, but they have not completed a clinical trial yet. I believe they are trying to raise funds. Hopefully they have an update to share this year. I will check.
Looks age appropriate i like how the crown area looks natural instead of a fake generic swirl. Looks good. https://www.instagram.com/p/BM11S-ghGt1/
Why doesn’t Kintor just post results on their website instead of delaying?
It probably means a lot more to them to release it at a conference to better raise visibility within the investment, clinical and scientific communities. Rather than just a post on their website.
https://www.instagram.com/p/B1FDu3MF-lL/ Dang.
Pretty impressive.
the U.S. Food and Drug Administration approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata
https://www.fda.gov/news-events/press-announcements/fda-approves-first-systemic-treatment-alopecia-areata
Admin,
Have you seen this video?
https://www.youtube.com/watch?v=Yehk_h_Uj6k
Very interesting theories, maybe worth a follow up interview?
I didn’t see that video Radula, thanks for sharing. I’m going to hold off on covering an interview for now until the theories are a bit more tested by others.
Working on a new article at the moment.
That’s awesome news for AA! I wish we had something that good!
Hey how are the US regulations of CRISPR? Would a company in the US be able to develop a CRISPR or RNAi knockout of the androgen receptors in hair follicles?
Rude, I don’t know exactly the US regulations of CRISPR, but I imagine it is the most poised country in the world to enter those trials. There are two companies who are already developing RNAi therapies for the androgen receptor, Olix Pharma and siRNAgen. siRNAgen even has a version which they are trying to put out as a cosmeceutical. Please use search function on this site to read more about them.