Amplifica Begins Trial For AMP-303
On June 28, 2023, Amplifica Holdings Group announced the initiation of a clinical trial for one of its lead candidate molecules from the study of hairy moles.
Amplifica’s AMP-303 has officially entered a clinical trial. According to a news release on the company’s website and PR Newswire, the first patient was dosed in a multicenter, randomized, double blinded and placebo-controlled study on June 27, 2023. There will be three subject groups within the trial: “subjects with recent onset of hair loss (defined as a history of hair loss of ~3 to 5 years), subjects with established hair loss (defined as a history of hair loss > 10 years); and subjects who have undergone a hair transplant procedure.” This innovative trial design will reveal some new insights into how hair loss drugs can impact hair transplant procedures.
What’s important to take note of, is that the molecule osteopontin, which is a part of the hairy mole-hair growth phenomenon and was recently discussed in the news, was identified as AMP-203 on Amplifica’s website. The compound announced today to enter clinical trials is AMP-303, a distinct compound. Also, SCUBE3 was previously announced on Amplifica’s website as AMP-601. Therefore, it’s possible that AMP-303 could involve CD44, or be a completely different compound which has not been previously discussed.
Amplifica expects this study to be completed in the first quarter of 2024.
Posted in Amplifica
The date range until Q1 2024 indicates that this study is not a standard phase 1 trial, which are typically completed within 60 days, pending enrollment. It will be interesting to learn more about AMP-303 as time rolls on.
Great News, thank you for sharing this. I really hope that the results will be good and we can be excited for novel hair loss Treatments. How long do you think would such a study with all phases take?
It’s hard to tell what type of regulatory path Amplifica is going for since we don’t know what the compound is. I think it may be possible that they could be looking at regulatory approval before 2027, or sooner, depending on certain details, like if 3 trials will be necessary.
Hey FT long time no speak lol, out of curiosity why would it be a possibility that 3 trials may not be needed?
Hey YoYo, depending on the type of compound it is, I have heard there are some substances where it may be possible to run a phase 1/2 trial and then go right into a phase 3.
Ah I see, personally I’m not sure that would be possible for osteopontin because it does have dangerous links to diseases such as Parkinson’s and Alzheimers but of course the trials would tell us better. https://www.nih.gov/news-events/nih-research-matters/osteopontin-may-play-key-role-alzheimer-s-disease
True, we’re certain that osteopontin is AMP-203 and not AMP-303 based on Amplifica’s own news releases.
I’ve been following Amplifica since the news release of Scube3. It seems odd that their focus seems to have shifted from ‘scube3’ trails to the ‘osteopontin’ molecule. There must be a lot of behind-the-scenes work that is not made public. I know the competition in this field is intense.
Yes, and I believe you must be aware from the article that AMP-303 is not osteopontin either, Steven.
This wired article states that AMP-303 is ‘a proprietary form of osteopontin’ http://www.wired.com/story/a-hair-loss-study-raises-new-questions-about-aging-cells/amp
You’ve got a good eye for news LJ, I had spotted that myself and was planning to share in the comments section. So, there are two likely possibilities here: 1) The journalist at Wired made an error, or 2) AMP-303 actually does include osteopontin in some fashion.
Journalist slight errors are somewhat common, and Amplifica’s own website pointed at osteopontin being labeled as AMP-203 (linked in the article), so I would learn towards #1, but it will remain to be seen for a while. I may try to clarify with Amplifica directly.
Nice one FT, you and the other blog are lights in the darkness honestly so thanks for all your efforts.
I also tend to agree with your interpretation, but Wired is also a decent outlet so it’s hard to call.
From “The booming business of hair loss” review discussed earlier this year, it looks like AMP-303 has been in their pipeline for some time. Here’s a link to the patent mentioned in that review – seems to be a combination therapy that they’ve had patented since 2012. It’s covering either AMP-303 or AMP-506 (or both), the latter of which I haven’t heard anything about since Amplifica announced their fundraising in 2021.
https://patents.google.com/patent/WO2012135230A2/en
I’m not well-versed in patent language, anyone have any input/interpretations?
Thanks for sharing Ryan, good find in the booming business review. I wonder if the authors of the review got that patent right for AMP-303/506.
So we know anything about the dosing of it? Is it like a cure (10+ years) or very infrequent top ups like 6 months – a few years?
Hey FT, suppose Osteopontin gets approved for use, if you had to guess, what year do you think it could be introduced into the market? Thanks
YoYo, I am still not convinced that osteopontin is being trialed currently by Amplifica, as has been discussed in this thread. If you’re asking when I think AMP-303 could hit the market, I believe it could be approved around 2026.
I respectfully disagree (but I could also be wrong) but I feel like there was a mistake on one of the news outlets and they mixed the name of the compounds creating confusion. https://www.wired.com/story/a-hair-loss-study-raises-new-questions-about-aging-cells/ In one of the paragraphs it states, “Plikus’ startup, Amplifica, began human clinical trials of a proprietary version of osteopontin in June. Participants will get it as a microneedle injection into the scalp. (He envisions it one day becoming a twice-a-year treatment, like Botox or a dental cleaning.) Amplifica is also continuing preclinical studies of SCUBE3.”
Yes YoYo, no problem about disagreeing, but where is the disconnect/disagreement? Amplifica’s own website says osteopontin is AMP-203 and the trial began for AMP-303. I’ve linked both of those things in the article and I believe in the comments. The healthline article you shared says “In late June, biopharmaceutical company Amplifica — co-founded by Plikus and based off his molecular research — announced the first in-human study of AMP-303, a compound that will be used to treat androgenetic alopecia, but doesn’t rely on osteopontin.“
https://www.healthline.com/health-news/scientists-investigate-solution-to-hair-loss-and-it-can-be-injected-like-botox#Next-study-will-include-humans
Yea you make very good points lol, I have no idea what’s going on
https://www.linkedin.com/pulse/clinical-trials-rundown-athenamedica%3FtrackingId=8pAKzFzaQqytE8wwCEifHg%253D%253D/?trackingId=qwY2Nx5Mb5aQ1koyRj6tHw%3D%3D I was able to find some mice pictures for Amplifica’s-303
Interesting YoYo, I have no idea how you came across this, but it does provide a brief insight into the AMP-303 product.
Thanks to Follicle Thoughts for your work. And you guys who also do some research…
Any news regarding this trial?