Scientific ACTH and related research

macgyver

Well-known member
Effects on Adrenal Growth and Adrenal Blood Flow:

Quite a lot going on in the adrenal glands where focussing on one related area doesn't do it justice regarding their importance. These are some symptoms of adrenal insufficiency:

  • Fatigue
  • Body aches
  • Unexplained weight loss
  • Low blood pressure
  • Lightheadedness
  • Loss of body hair
  • Skin discoloration (hyperpigmentation)

From the Sapienza University article: "In contrast with these results, in animal models, ACTH regulates adrenal gland trophicity (28, 39) and increases adrenal blood flow (40). Furthermore, glucocorticoid-induced suppression of ACTH inhibits cell proliferation, induces apoptosis, decreases adrenal weight and cellularity of the adrenal cortex, and triggers vascular changes through loss of vascular endothelial growth factor protein expression, thereby causing regression of the vascular network".

"The adrenal glands have a rich blood supply and experience one of the highest rates of blood flow in the body". https://courses.lumenlearning.com/nemcc-ap/chapter/the-adrenal-glands/
 

macgyver

Well-known member
Effects on Adrenal Medulla:


 
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macgyver

Well-known member
Edit: I will follow up with the remaining therapeutic possibilities and links to relevant papers as time allows. Once completed, I will look at related disorders for each category and their prevalence. Will require some deep diving to link to secondary effects involving neurodegenerative disorders as an example, but hopefully after this point is reached we’ll have a better understanding of where PW might be taking the company.
 

Alexius

Well-known member
@macgyver Really appreciate the effort you're putting into researching the potential of ACTH, thanks a lot!

A brief summary of what I understand so far:
  • ACTH has the potential to be used in many indications (addressed and unaddressed ones)
  • Clinuvel has a competitive advantage through its patented release method (implant)
  • Due to its research capabilities, Clinuvel might be able improve the formulation of ACTH to i) reduce side effects and/or ii) increase efficacy to gain another advantage over competition
  • There are a few competitors (such as ANI pharmaceuticals and Mallinckrodt (especially after restructuring))
  • ACTH is not patentable, so it's an open market for everybody
  • Acceptance by the scientific community and regulators is better than for afamelanotide, so time to market might be shorter
  • According to Johnny H, Clinuvel has to file an aNDA at the FDA which does not require any clinical trials (if this is true it is a huge advantage, as Clinuvel already seems to be overstrained resource-wise with the current clinical trials)
Concerns/Questions/Comments arising in my head:
  • When it's an open market and Clinuvel intends to address huge indications (e.g. stroke) with ACTH, it's just a matter of time when competition will catch up and smell their chance. To me it seems that the release method alone is only a weak competitive advantage if the indication is worth potentially 5-10 BUSD/yr.
  • The submission of an aNDA might be sufficient to address the diseases already treated with ACTH, but not new diseases, right? If this is true, I see bottlenecks (staff, time and money) to drive clinical trials for the development of new indications.
I believe PW is hoping for a "quick" new revenue stream from ACTH in particular, which can be used to fund further studies (Phase 3 Stroke & Vitiligo) and inorganic growth. The cash from EPP is not enough to move forward appreciably and in a reasonable time frame with such huge indications in the pipeline.
 

macgyver

Well-known member
@Alexius Nice summary mate, and I agree with your belief PW is after a quick return initially to sustain the company and drive expansion and development. Competing against Mallinckrodt directly is definitely the lowest fruit to pick, a 10% slice of their Acthar revenues is nearly double current EPP revenues. If Mallinckrodt engage in a price war, Clinuvel has nothing to lose and everything to gain being a new entrant, indeed Mallinckrodt can ill afford a price war with their bankruptcy woes so 10% appears very conservative. They will have to relent and give up market share unless they spend half a billion dollars lobbying the FDA!🤣

Regarding IP and delivery systems, there’s only so much Clinuvel can do to shore up their competitive advantage. I don’t think that matters a great deal, they’re entering an open market with a peptide thats been around for a long time. Simply by entering the ACTH market with a competing product will be very lucrative in itself. But I have no doubt PW will try to secure all facets of IP regardless, he’s a cautious man and it would go against his grain to not strengthen his legal position, or his personal financial position for that matter😉😜
 

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