Clinuvel

Sherlock

Well-known member
I have absolutely zero doubt that afamelanotide works in all three areas ... photoprotection, DNA repair, and inflammation control. Why? Because I've used it and I know what my normal body response would be without it. If you can prevent a bad to horrific sunburn from occurring, then you know afamelanotide is doing these things. Will it work in stroke victims? I say absolutely ... the damage from stroke is death of brain cells due to lack of blood supply and the resulting inflammation that occurs from the blockage. I believe that Prenumbra will control the inflammation because it will moderate the the cell signalling that causes the inflammation at its root. The XP trials put the spotlight on how well Scenesse will perform in the area of DNA repair, so I am very keen to get those results.

But to me, the most significant effect out of all of the wonderful things this synthetic peptide does has always been inflammation control. So many big diseases could be made less harmful or potentially manageable with a healthy dose of inflammation control. We have seen this recently with COVID-19. The virus is most destructive due to its inflammatory after-effects. Control that and you control its lethality.

As far as breaking through the skin barrier ... really you need only the amino-acid sequence (His-Phe-Arg-Trp) which is the minimal sequence required for selectivity and activation of the MCRs (except for MC2R). The trick is how long it will stay activated. For improved staying power, you need additional post-translational modifications on the end(s) of the peptide. This is (actually one of 3 things) that distinguish synthetic Scenesse vs. our natural a-MSH.

The biggest risk in my mind is not the efficacy of the drug at all ... it is management's ability to execute and get the drug to market for a wide variety of indications big and small in a timely manner before either patent expirations or the bigger threat, competition in the form of a competing drug candidate. All it would take is for somebody to discover just one amino-acid difference or one different post-translational modification to create a legally recognizable NEW drug that performs just as good or better than what Clinuvel has in its portfolio and the future financial situation of the company would have to be refactored.

And really, it doesn't even have to be the same or similar set of amino-acids as we have seen. Its shape could be cyclic vs. linear as what Palatin has in its portfolio with Bremelanotide. All this new peptide or even molecule would have to do is fit in the 7-transmembrane GCPR pocket of the MCRs and keep them activated.

This is what keeps me up at night ... until Clinuvel management can execute as promised. They have money to spend on R&D. Why aren't they making sure there are no other potential peptide configurations out there that might compete? MT-7117 is nothing like Scenesse structurally, yet if it can stimulate the MCR pocket effectively, it could potentially be a rival drug. This is why time is the only risk factor to me.
Thanks for your insights! This was the response I was hoping for with my question. We're not out of the woods yet. Far from it. I'm pretty sure PW has these on his radar as well, so probably autorities / paperwork / competition are the main cause of the timing I assume. I don't have the impression the board is sitting on their behinds while watching the sun rise and set.
 

marioki

Member
@DenzelWash PC5 is all about topicals, and then also a pediatric formulation of Scenesse. I still think enfance could be a topical and that it is somehow linked to the OTC lines.

Imagine the validation it would give to an OTC line if PMLE patients, EPP children and others with real diagnoses get a benefit from an OTC lotion. Even though you sell the products at a reduced price the potential is huge in actual sales. Admittedly, it would be a conundrum, though, because how would you then not claim a medical benefit from the OTC product and how would the regulators not come after you? Perhaps the answer lies in the pharmaceumable concept. A rebranding of the not so loved cosmeceutical niche where a potent peptide (derivative of Afamelanotide) is sold to the general public as well as some of the patient groups who would be to big and to vague wrt symptoms to reach through clinical trials - as something in between a medical and an over the counter product.

Could the lotions be marketed in different %? So an Rx version of Enfance with x % of the peptide and an OTC version with a lower %.
but that chart confirms that non of first OTCs will be "melanogenic"
 
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johnnytech

Moderator
Staff member
@endymion96
This is a great post. You hit major themes all very well. Seriously great job.

But to me, the most significant effect out of all of the wonderful things this synthetic peptide does has always been inflammation control.
What you said above about inflammation is why I think the 6th indication will be dementias, like Alzheimer's. I was talking to a director of an old people's home a couple weeks ago, we were talking about afamelonatide's medicinal effect in the areas of stroke and dementia. And she said, "oh, it must be really good at controlling inflammation then". She then went on to show a good awareness of medicine in the ensuing conversation.

One anecdote she said, an old fashion early symptom of Alzheimer's was how much inflammation was present in the gums of the teeth. Apparently that pointed to inflammation elsewhere that was a good pre sign of Alzheimer's.

You hit the nail on the head with management. I think it's because of management we disappointedly saw nothing about covid applications.
 

macgyver

Well-known member
The first XP patient was trialled over 42 days. 6 biopsies each for 6 patients in CUV 150 so would be one a week for 6 weeks finishing around middle of July. I’m assuming this trial has expanded to cover the XP-V variant as well. Looks like it’s in Europe. We can be fairly confident they have recruited and set up all patients already as logistics etc is onerous on the patients. The results will be a while coming out, maybe just before the AGM?👀🤔
 
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KRD

Well-known member
@endymion96 Excellent post Endy. Your insight, especially from someone who has experienced the drug first hand, is especially valuable. Here's a thought given afamelanotide's anti inflammatory benefits - will patients receiving the drug on regular intervals, say 4 to 6 times a year, end up being "healthier" than the general public. Since many diseases have an inflammatory element to them would the regular intake of afamelanotide into their system over an extended period of time prevent many diseases from ever occurring?

One benefit of maintaining the strict patient registries over a period of years may be to see if this hypothesis could be proven.
 

KRD

Well-known member
Great find Mac!

So it looks like the trial has been run from Germany, and that it is almost complete?
See screenshots below.
View attachment 1521
View attachment 1522
View attachment 1523

The last newsletter came out on June 2. It stated the DNA Repair/XP trials would commence “in the coming weeks” so I wouldn’t be certain June 1 marks the first patients being treated. Possibly everything was set to go, i.e. patient enrollment, etc.
 

fozz

Well-known member
The first XP patient was trialled over 42 days. 6 biopsies each for 6 patients in CUV 150 so would be one a week for 6 weeks finishing around middle of July. I’m assuming this trial has expanded to cover the XP-V variant as well. Looks like it’s in Europe. We can be fairly confident they have recruited and set up all patients already as logistics etc is onerous on the patients. The results will be a while coming out, maybe just before the AGM?👀🤔
guess this means 2 trials underway and awaiting readouts this year add phase3 vitiligo later this year add pharmaceumable lotion launch later this year and christmas might be coming twice this year!!! not forgetting the $$$$$ growth in the 2 reports coming in few weeks time......
 

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