Cell Therapy News/Articles, page-8249

Great post @col69
I am not sure how many remember about my Christmas Eve post where I pretty much declared that Entresto would be a great complementary treatment to Revascor.
That is pretty much what Dr. Silviu Itescu has said in the Edison Open House Webcast just 2 days ago.

In case anyone missed it, here is my post from 12/24/2020, a full month prior to the SI Edison Open House Webcast:

Here's comparing Novartis' Entresto and MESO's Revascor

Entresto is Novartis' FDA approved drug (approved in 2015) to "reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction (HFrEF)."

Novartis later filed a supplemental New Drug Application (sNDA) for in the treatment of heart failure with preserved ejection fraction (HFpEF).

Around the same time that MESO's CFF P3 trial results were released, news came out that, by a 12-1 vote, the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) found that Entresto was worthy of some indication based on the PARAGON-HF trial.

Both news being announced on the same date (give or take a few hours due to the time differences between continents) is purely coincidental, of course.

But what strikes me as remarkable are these:

1. In Novartis's PARAGON-HF trial for Entresto, the primary efficacy endpoint for the trial was a reduction in hospitalizations for heart failure and cardiovascular death.

2. Trial data supported the benefit of Entresto in reducing worsening heart failure (total heart failure [HF] hospitalizations and urgent HF visits in patients studied.

So the trial met one of its primary end point - reduction in hospitalizations.

3. Bit here is the not so good news for Novartis on the other primary end point - which is reduction in CV deaths.

Here is a quote:

"An important issue the FDA (CRDAC) committee considered was that the phase 3, randomized, double-blind, double-dummy, active controlled PARAGON-HF trial results did not reach statistical significance for reducing morbidity and mortality among individuals with HFpEF, when comparing sacubitril/valsartan to valsartan alone"

https://www.ajmc.com/view/fda-panel-votes-to-expand-use-of-heart-failure-drug-but-doesn-t-agree-how

Contrast that with MESO's CHF P3 trial results where the primary end point of reduction in recurrent hospitalization was NOT met, but the secondary end point of reduction in CV deaths was met (major reduction of 60%). Pretty much the exact opposite of Novartis' PARAGON-HF trial results.

So the results from Novartis' PARAGON-HF trial perfectly complement MESO's CHF DREAM trial.

If Novartis is looking at this, they should be very interested in what I believe would be an end-to-end heart failure treatment that combines Entresto for reducing recurrent hospitalizations and MESO's Revascor for reducing incidence of heart attacks or strokes and reduction in death from cardiac causes.

Synergy?

Complementing treatments?

What is extremely encouraging is the fact the MESO's REVASCOR results were achieved "on top of maximal therapies", meaning REVASCOR was given in addition to other therapies. So for Novartis, REVASCOR would not be a competing drug but a supplementing drug to Entresto or Inclisiran.

A highlight of MESO's REVASCOR is that there was a reduction in the incidence of STROKES (as well as heart attacks).

@taylorstjames - thank you for the tags.

PS: My post is not financial advice. Please do your own research for your financial decisions.