Amplifica Reveals Results from Its First-in-Human Trial For Androgenic Alopecia
Amplifica, a clinical-stage biopharmaceutical company based in San Diego, has announced the results from its first-in-human trial of AMP-303, an intradermal injection treatment for androgenic alopecia (AGA). Amplifica has several AGA treatments in the pipeline, including AMP-203 (osteopontin) and AMP-601 (SCUBE3).
What is AMP-303?
We spoke about AMP-303 last year when they announced the initiation of its trial. While we don’t have the full details about the product, we know that it is a proprietary formulation developed for intradermal injection into the scalp to treat AGA.
Trial Results
According to the press release, male participants aged 18-45 with AGA were included in the study. These participants were split based on the duration of hair loss: recent onset – 3 to 5 years and long-standing hair loss – over 10 years. The participants received intradermal injections of AMP-303 on one side of the scalp and a placebo on the other.
- A statistically significant number of participants showed a greater than 15% increase in non-vellus hair count from baseline compared to a placebo at 60 days post-treatment.
- A statistically significant number of participants showed a greater than 10% increase compared to placebo at 150 days post-treatment.
- Adverse events were mild in severity, with no severe adverse events reported.
Amplifica says: “The success of the AMP-303 study not only validates our approach but also sets the foundation for advancing additional programs in Amplifica’s pipeline”.
Reflections
While the results might be positive, it is difficult to determine the clinical relevance without images or raw data. Hopefully, Amplifica can provide these in the future.
Let us know what you think about the results in the comments below.
Posted in Amplifica
Did they start a clinicla trial and was it the phase 1? Will the phase 2 now start?
Does it need FDA clearance?
Since there is efficacy studied here, does that mean it’s not Ph1?
lj, i’m not sure but the way Ive been following I think this was some sort of hybrid phase1/2 and that the type of substance they r using can make it thru trials faster than a typical drug. its like an injection like a botox
I mean this is definitely encouraging alongside Pelage’s results too. I feel Amplifica and Pelage are the beacon of hopes for hair loss sufferers until a more permanent solution such as Stemson or Fukuda will come out
Hi Yoyo, I see you are a very active member of the forum and often provide useful insights. What’s your person view on when hair cloning will be commercial available? Like how many years from now? Thank you.
Hi Anna, thanks for the kind words. I don’t want to say a year and damper your expectations, however I will say this. Science and technology is better than ever before and for the first time there has been a clear effort in the field of hair loss. Amplifica, Pelage, Eirion etc. When it comes to hair cloning there are two companies I’m interested in, Stemson and Fukuda, (not a fan of Tsuji). Stemson have confirmed their clinical trials for 2026, and Fukuda have confirmed clinical trials in the next 5 years (this was last year). I can see it coming to fruition POSSIBLY in 2029/2030 depending on factors such as, where they do the trials (such as Japan or South K.) how the results look like etc. But Stemson is the real deal and they seem genuinely interested in making hair loss a thing of the past. It’s a long process but I think we’ll be fine, as long as Amplifica or Pelage can pull through (I’m leaning more so on Pelage) we can have a safer and more effective treatment until hair cloning can be a reality.
Pelage seems legit, look at their team. PhDs and MDs from Harvard. We are closer, 5 more years, lol but technology is more powerful than ever and making headway!
Yoyo, thank you so much 🙂 Let’s pray that our hair cloning will cure us by 2030.
Hello Yoyo. I recently went to a dermatologist who is involved in research studies, conferences, and quite up to date. He has a YouTube channel in Spanish and although I had already heard it in his videos, he repeated it to me again. “Until 10 years from now there will be nothing that can be of similar effectiveness to anti-androgens in pills or Minoxidil and they will be of the cell regeneration type but not more powerful than these.” I would like to know why you are so optimistic. It is difficult for me to be one since 17 years ago my baldness had already been cured with cloning.
Whats your opinion about FOL005 or Follicopeptide? Coegin is planning for launch already next year.
Agreed
still no cure but have a con covid cure in minutes kittke odd ha should make you think
I have FFA my dermatologist hasn’t given me any real advice except to tell me my hairline will not change me back and could get worse. I used minoxidil for a year but now just oil my scalp and look after my hair which is quite dry
This is very unhealthy, do not spend your life following every little baldness “cure”, it is not an affliction but the mental processes endured doing this definitely is one.
This way madness lies.
Maybe they will have better luck with AMP-601 (SCUBE3).
Or not,who knows.
no pictures?
if I had a product that was effective at growing hair, you better believe that I would be publishing dozens of pictures everywhere.
I sure wish Amplifica would stop putting their time, effort and money in what I consider possible “secondary treatments” and get to the real ‘meat’ of things! Yes, I’m talking about “SCUBE3” also known as AMP-60. This was the big item of hair loss news in 2022! I was really disappointed when I found out that Amplifica was not using a SCUBE3 based treatment for their first human trails! Perhaps I missed something regarding these other items, but with all SCUBE3’s media coverage and excitement came out in 2022, it looked to me like the most promising potential treatment we’ve had in a long, long while. I just can’t get too excited about any new treatment that may offer a possible 10-15% increase in non-vellus hair counts. Heck, we have treatments now that can do that or better!
So what IS AMP-303? It’s not SCUBE3 or Osteopontin, but a 15% increase in hair count it promising, was this applied to bare scalp? or to areas that still had some hairs?
I agree with Ted – Pictures of scalps showing more hair on one side, but…………
This Solution is associated with cancer. So, it doesn’t matter if it can make grow a full head of hair; because it is involved in cancer it won’t see the market.
When do we think please or amplifica will be available?
Anybody have a realistic timeframe for Pelage or amplifica?
Anybody?
Even if their trails turn out all positive, I can’t imagine anything reaching the market within the next five years. I think even that is optimistic, after watching many possible new treatments moving through the process over the last 20 years. However, I do remain ever hopeful that we will eventually have a viable, effective treatment.
Looking at fda approval if pelage is in phase 2A that’s still 5-7 years away. Our FDA process is a broken mess. Decades to get anything done. AI will move so much quicker than regulatory approval, so what happens then? Lord know government won’t implement the same AI to approve things as quickly as needed. Fuck this is annoying. Not even worried about myself. Worried about my 9 year old son with thin shitty hair.
Is anything coming out in 2025???