Category Archives: Osteopontin

AMP-303, Amplifica, CD44, Hairy Moles, Maksim Plikus, Osteopontin, SCUBE3

Amplifica, Hairy Moles, Osteopontin and SCUBE3

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Among newer companies involved in trying to cure hair loss, Amplifica (US) is particularly interesting. It was co-founded in 2020 by Dr. Maksim Plikus and Dr. William Rassman, both of whom I have covered before. The company’s two main areas of product development involve hairy mole related protein osteopontin and the SCUBE3 signaling molecule. The top half of this post has the most recent updates.

Update: September 30, 2024

Great Results from Amplifica’s First-In-Human Trial of AMP-303

Amplifica’s AMP-303 Phase 1 trial results have come out, and it is very good news.

“A statistically significant percentage of study subjects showed a greater than 15% increase in non-vellus hair count from baseline compared to placebo at 60 days post-treatment, and a greater than 10% increase compared to placebo at 150 days post-treatment.”

Moreover, there were no major safety issues from the intradermal injections, and just a single AMP-303 treatment cycle increased non-vellus hair count. In addition, the increase in hair density and thickness was sustained over time (150 days post treatment).

Best of all, the results demonstrated AMP-303’s ability to transition vellus hairs into non-vellus hairs. This implies not just hair thickening, but also the far more difficult hair loss reversal.

Update: July 12, 2023

An interesting take in wired on this same hairy mole (aka nevi) and hair growth research. They connect it to the well known phenomenon of dormant senescent cells and aging.

Update: June 28, 2023

Amplifica Begins Clinical Trials for AMP-303

Amplifica just announced that it started clinical trials for its lead candidate AMP-303. The first human subject was given a dose on June 27, 2023 and the study will finish in the first quarter of 2024. According to CEO Frank Fazio:

“Aside from assessing AMP-303 in subjects with androgenetic alopecia, this study will serve as a strong foundation for subsequent clinical studies with Amplifica’s pipeline compounds.”

We already know at least three compounds or molecules that they will likely test in clinical trials (with more to come):

  • Osteopontin = AMP-203 per the DermWire interview I linked to previously.
  • SCUBE3 = AMP-601 per my January 2023 update.
  • CD44 = AMP-303? Not clarified in this latest press release.

Update: June 21, 2023

Amplifica Osteopontin (Hairy Mole Molecule) Clinical Trials Beginning Soon

Hairy Moles Osteopontin
Hairy moles, osteopontin and hair growth.

I previously (see bottom of this post) covered Amplifica and its hairy mole research. The company’s founder Dr. Plikus and his research team discovered that a molecule called osteopontin is primarily what makes hairy moles grow hair.

Morover, this molecule can induce hair follicle growth when administered anywhere on the skin. The initial work was on mice, but the company plans to begin human clinical trials later this Summer per the latest update from today in Insider magazine. Dr. Plikus believes that this compound:

“Could be needled into the scalp of balding men and women to reawaken hair follicles that have gone dormant, in a near-painless Botox-like procedure.”

The treatment and trials will likely involve a combination of osteopontin and some other, newly-discovered hair-growing proteins that Plikus and his team have found. The Insider article implies that the other molecule will be SCUBE3 (already tested via microinjections in mice).

The team’s latest findings in relation to hairy moles and osteopontin were published in Nature magazine: Signalling by senescent melanocytes hyperactivates hair growth. A summary from today is also available on the company’s website.

The study describes the essential role that the osteopontin and CD44 molecules play in activating hair growth inside hairy skin nevi. In addition to these two molecules, the team thinks it is likely that their continued research will identify additional potent hair growth activators. Make sure to read the UC Irvine report of these findings.

Interestingly, Dr. Plikus says that this Nature publication is the result of nearly 10 years of research by an international team of scientists. The most encouraging quote of all from Dr. Plikus:

“It will grow like you remember it when you were 18. It would not grow like thickened, wiry armpit hair. This burst of molecules is shown to hair follicles on a scalp, and they’re like, ‘Oh, OK. Time to grow!'”

Update: In an interview with DermWire, Dr. Plikus says that the osteopontin-based compound highlighted in the Nature publication is designated as AMP-203 at Amplifica.

A Note on Osteopontin and Hair Growth

Note that I previously covered osteopontin in a number of my posts on Follicum, a company which disbanded in 2021 but came back in 2023 under new ownership. Their use of an osteopontin based peptide was slightly different from what Amplifica will be doing via osteopontin (plus other molecule) injections.

Follicum’s Phase 2 clnical trials resulted in a hair growth increase of 6.6 hairs/cm2, which was deemed insufficient to continue with Phase 3 trials at the time. Hopefully, the company’s new owners will have a change of heart.

Update: March 27, 2023

An interesting new UCI article covering the work of their hair scientists Maksim Plikus and Natasha Mesinkovska. Per Dr. Plikus:

“Most likely, SCUBE3 would be microinjected less than a millimeter beneath a person’s skin, a “fairly painless” process that would have to be repeated periodically to maintain hair growth”.

Human trials on Amplifica’s lead compound (likely not SCUBE3, which was my original assumption) are expected to begin later in 2023.

New Agreements with Ingenza and University of California

January 26, 2023 — Amplifica signed an exclusive licensing agreement with “The Regents of the University of California” for a proprietary pipeline hair growth molecule (SCUBE 3) that has been in the news a lot lately. Key quote:

“This early-stage compound (SCUBE3) will now be referenced as AMP-601 and is currently undergoing pre-clinical testing at Amplifica.”

January 20, 2023 — Amplifica to collaborate with UK-based Ingenza in order to advance novel alopecia treatments involving the former’s signaling molecules and proteins.

November 14, 2022 — Make sure to watch the below interesting recent video presentation by Dr. Plikus:

October 24, 2022

Amplifica

I previously mentioned new hair loss company Amplica in my post about Dr. Maksim Plikus’s research on the Scube3 molecule for hair growth. He partnered with Dr. William Rassman to create Amplifica. The latter announced his involvement via a Reddit comment in July 2022.

Amplifica Signaling Molecule
Amplifica announcement by Dr. Rassman on Reddit.

Earlier today, it was announced that Amplifica just completed a $11.8 million Series A Financing round. These funds will enable clinical development of the company’s lead products to treat androgenic alopecia.

These lead products are listed as “AMP-303” and “AMP-506”. The press release states that they expect to initiate first clinical trials in fiscal year 2023.

Amplifica
Amplifica.

Amplifica, Dr. Maksim Plikus and Hairy Moles

Note that Amplifica was first mentioned in a 2020 news article in regards to the new company’s interesting work in relation to hairy moles. At the time, a team led by Dr. Plikus discovered that molecules from moles that grow excessive hair can induce follicle growth when administered anywhere on the skin.

Make sure to also read my past posts on Dr. Plikus and his many areas of hair loss research breakthroughs. His team is based at the University of California, Irvine (UCI).

Amplifica is yet another new company added to my main page on hair loss research around the world.

Coegin Pharma, FOL-005, Follicum, Osteopontin

Coegin Pharma to Release Follicopeptide Gel in 2025

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Coegin Follicopeptide
Coegin Follicopeptide. Mockup image of potential future products from Coegin’s Twitter account.

I covered Follicum (Sweden) and its FOL-005 (now FOL005) hair growth peptide in eight posts between 2015 and 2021. This was prior to the company’s cessation of work on FOL005 and acquisition by Coegin Pharma (Sweden) in 2022. However, this product is now back as a cosmetic called Follicopeptide that will likely be released in 2025. The top half of this post has the most recent updates.

Follicum’s unique osteopontin based hair loss treatment is very interesting. This product can both stimulate scalp hair growth and reduce excessive body hair growth (hirsutism). And the same technology could potentially treat diabetes and inflammation related disorders.

September 24, 2024

Coegin Pharmahas has signed a joint development agreement with Scandinavian Biolabs to develop a portfolio of products based on FOL005 for hair growth. Initial product launch is expected in the second half of 2025. Scandinavian Biolabs already has a presence in the hair loss world via its Bio-Pilixin hair strength shampoo, conditioner and hair activation serum.

September 11, 2024

Follicopeptide

Coegin Pharma’s INCI application for FOL005 was approved at the end of May 2024. The hair loss cosmetic gel will be called FollicopeptideTM and is being prepared for a global launch. The key ingredient will be listed as “sh-Oligopeptide-128 SP”. For more details, see Coegin’s pipeline page. Per the company’s Twitter announcement image, they will produce a range of products containing Follicopeptide.

INCI stands for International Nomenclature of Cosmetic Ingredients. A number of companies have in recent years targeted the hair loss market via cosmetics. This includes Kintor via KX-826 (Pyrilutamide); Sirnagen via CosmeRNA; and Yuva Biosciences/Bosley via Revive+ Densifying Foam.

August 12, 2024

Coegin Pharma has signed an agreement with the University of Bradford (UK) to commercialize groundbreaking hair and skin pigmentation peptides. Their goal is to release a topical self-tanning product based on the peptide NPP-4 as early as 2026.

October 25, 2023

Coegin to Release FOL005 Hair Growth Peptide Gel in 2025

Some major new updates since I wrote the summary earlier this year (see second half of this post).

“After carefully analyzing the possibility of launching FOL005 as a cosmetic product line, we have come to the conclusion that it is an opportunity with great potential. This will minimize development risk, significantly reduce capital requirements and strengthen commercial opportunities in the short and long term. We have therefore revised our strategy and now aim to launch FOL005 as a cosmetic product series as early as 2025 with the USA as the first market.”

It seems like CosmeRNA started a great new trend. No more ten year clinical trials and failure to come to market.

  • Follicum’s website was temporarily restored and updated very recently. The milestone plan page has a detailed chart for FOL005:
Coegin Pharma Follicopeptide (FOL005 from Follicum).
Coegin Pharma Follicopeptide (FOL005 from Follicum) milestone timeline.

April 8, 2023

Follicum Past Clinical Trials

I covered both of Follicum’s past clinical trial results in 2017 and 2021, respectively.

  • In 2017, Follicum’s Phase 1 clinical trial results were released. They were deemed as positive (8 percent increase in hair growth), with an effect comparable to that of Minoxidil. Moreover, safety was not an issue, with no major side effects in trial participants.
  • In 2021, Follicum’s Phase 2 clinical trials of FOL-005 came out. The topical compound resulted in a 6.6 hair/cm2 increase in hair growth, but this was deemed to be insignificant compared to placebo.

Thereafter, the company ceased further development of FOL-005, and it all seemed over for yet another false flag operation. Or perhaps not?

Merger and Acqusition by Coegin Pharma

In September 2021, Coegin Pharma merged with Follicum. This merger was confirmed as an acquisition in 2022.

In the first of the two links above, Coegin’s CEO Tore Duvold said something of interest in the interview:

Question: “With regard to the hair loss project, which has recently been put on hold, how will it be handled once the companies merge”?

Answer: “Follicum announced that they have paused the hair loss project. In Coegin, we have strong capabilities in dermatology, and we will review and analyze the results before we make any conclusions”.

Follicum Back in the News

  • In March, a Tweet from Coegin indicated that they were meeting with potential partners for Follicum’s FOL-005.
  • Follicum was mentioned in February in an updated article titled: “Could We See a New Dawn for Hair Loss Treatments?”. It summarizes the problems that the company faced in trying to bring FOL-005 to market after the unimpressive Phase 2 trial results.
  • When going through Coegin Pharma’s website, I found a highly detailed comprehensive corporate presentation on Follicum and FOL-005. It was presented at the end of 2022 by Coegin’s COO Kristian Lykke Fick.

Their take on the past trials is more positive. Key quote:

“FOL005 1.5% dose was on par with treatment effect reported for minoxidil and finasteride with a growth of 12 hairs/cm2 after 4 months of treatment. However, with more than 60% of subjects responding to treatment compared to competitors where 40% responders effect is previously documented after 4 months.”

Note that Follicum’s old Swedish website is being routed to the English site that has an expanded research section on FOL-005. In 2022, they also filed for a patent related to wound healing. I am surprised they do not mention anything in relation to their osteopontin-derived peptide’s body hair growth inhibition.

Follicum plans to conduct various new scalp hair growth related clinical trials from 2023-2027. On their website’s plans section, they state the following:

“We believe there is a high likelihood of success based on the previous clinical data.”

Too bad about the new time frame and the wait for venture partners for funding. Otherwise, I am not entirely pessimistic about this product. I do feel that it can compete with Finasteride and Minoxidil in terms of effectiveness, but via a totally different mechanism of action. And with no serious side effects.

Follicum’s frequent press releases, CEO Jan Alenfall’s presentations, and the company’s rapid clinical trial progression impressed me. Their chief business officer Gunnar Gårdemyr was also in regular communication with me in the past.