Follicum Prepares For Phase Iia For Fol-005

SwissGuy

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Nice, but earliest release for Follicum is 2021.
 

BaldyBalderBald

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Anyone could explain what mechanism is behind FOL-005 ? Only things i could find is the use of some kind of peptide that can both inhhibit or stimulate hair growth, they showed 8% hair growth on their first trials.
 

Dlogic

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Anyone could explain what mechanism is behind FOL-005 ? Only things i could find is the use of some kind of peptide that can both inhhibit or stimulate hair growth, they showed 8% hair growth on their first trials.


They don't exactly know themselves as they are doing more trials to fully understand the mechanism. I have checked all their videos (for investors) and they hope to have better answers to this question in 6 months period.

Some people complain about their previous trial not being used on head but on the leg, but they explained that they actually expect better results on head. I just don't remember exactly what the reason was for this.
 

BaldyBalderBald

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They don't exactly know themselves as they are doing more trials to fully understand the mechanism. I have checked all their videos (for investors) and they hope to have better answers to this question in 6 months period.

Some people complain about their previous trial not being used on head but on the leg, but they explained that they actually expect better results on head. I just don't remember exactly what the reason was for this.

That's...disappointing
 

vernon

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lmao how is there already an estimated release date when the company itself doesnt even have a clue about what their product is supposed to do yet and how
 

MrV88

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From hairlosscure:

Follicum has, in collaboration with international R & D partners e.g. Charité Hospital, Berlin, Germany, evaluated FOL-005 (a peptide) in different models for regulation of hair growth – both in-vitro and on humans. Our development process may briefly be described as follows:

  • Trials on mice (2012).
  • Trials on human tissue in-vitro (2013).
  • Trials on human tissue transplanted on mice (2015).
  • Toxicity trials, three months (2016).
  • Clinical phase I/IIa trial on humans (2016/2017).
  • Development of a topical formulation for FOL-005 (2017/2018).
  • Beginning of 2018 Follicum will start a clinical trial (phase IIa) in Alopecia on scalp. This time including 60 alopecia patients. The study will read out during end 2018.
Preparing for further clinical trials of FOL-005, Follicum conducted two separate three month toxicity trials during 2016. Both trials showed FOL-005 to be safe for further administration.

During the period from late 2016 to early 2017 the first clinical trial was carried out on healthy humans at the Charité Hospital of Berlin. The main objective of the trial was to confirm the safety of the drug, FOL-005, and to measure effect and response. The results showed, first of all, that the treatment was safe while also showing a considerable increase in hair growth. In all, 76% of the trial participants with the second lowest dose of FOL-005 during the trial showed increased growth. At this specific dose, the growth was stimulated roughly 8% compared to before treatment. The increase is statistically verified (p=0,0038). Please note that this was a short 3 month trial on thigh and that the next study will be on 60 Alopecia patients on scalp.

We are in parallel with the clinical program developing three different topical formulations from which we will select the one that is most attractive during Spring 2018 to be used in phase IIb clinical trials 2019. The prototype formulations are the following:

  1. Powder formulation – FOL-005 in emulsion of lipid-based suspension.
  2. Cream – nanoparticles of FOL-005 in lipid-based suspension.
  3. Gel – FOL-005 incorporated in polymer nanoparticles.
 

MrV88

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http://follicum.se/en/important-new...te-fol-005-in-hair-follicle-cells-identified/


Lund, Sweden, January 18, 2018. Follicum AB (“Follicum”) today announced that new research has identified receptors in human hair follicle cells that its lead candidate FOL-005 binds to. The newly acquired knowledge paves the way for a better understanding of how FOL-005 can be used for treatment of hair loss, and a significant milestone in the continued development of FOL-005.

Investigation of mechanism of action
The research into FOL-005’s mechanism of action was conducted in collaboration with a specialized Swiss company (Dualsystems Biotech) and aimed to identify the proteins that FOL-005 binds to. Two different cell lines from human hair follicles were used and as a result several interesting receptors were identified. These will now be further mapped in detail in preclinical trials. Corresponding studies are also being conducted to identify receptors relevant for the company’s separate diabetes project.

CEO Jan Alenfall comments
The positive news that we have now identified exciting receptors for FOL-005 allows us to build a specific rational for how FOL-005 works. The information is also important for our understanding of whether FOL-005 can be used for other hair indications in the future, how other types of hair growth disorders such as hirsutism and how different types of hair loss can be treated. The new results are also very valuable for us in our ongoing discussions with both regulatory authorities and commercial partners.

About FOL-005
FOL-005 is a short and modified sequence of the human proteinOsteopontin, a protein that has been suggested to play a role in hair growth. In several preclinical studies in a mouse model, treatment with FOL-005 has resulted in a dose-dependent increase in hair growth. The first clinical Phase I/IIa study with FOL-005 was completed during 2017 and showed that treatment with FOL-005 was safe and resulted in higher hair density, 8% increase at the best dose. Moreover, a high number of responders, 76%, were observed. Currently preparations for a Phase IIa study on Alopecia subjects are ongoing.
 
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