MESO's CHF P3 results are phenomenal in terms of reduction in mortality due to cardiac causes and reduction in incidences of heart attacks or strokes. 60% in both cases. When treated early.
In an earlier post (which got moderated because a sore loser basher could not handle the truth, I obviously got under his skin), I highlighted how perfectly Novartis' Entresto would complement MESO's Revascor, making for a perfect end-to-end treatment in heart disease. Combine that with Novartis' LDL-C reducing drug Inclisiran and you have an incredibly powerful treatment for the number one killer in the world - heart disease. By the way, for those who might have missed it, I re-posted my previous post detailing Entresto and Revascor at the end of this post
(it begins after the dotted line).I strongly believe that MESO's Revascor's knock-out results in the secondary endpoints presents a massive blockbuster opportunity for a big pharma partnership.
There is enough evidence to suggest that there is a renewed interest in CV drug development.
I quote from an article (link below) the following (
and it mentions Mesoblast):
"...New treatment approaches to cardiovascular diseases, leveraging innovative drug modalities and novel biological targets, have successfully advanced into late-stage development.
Recent acquisitions suggest that cardiovascular research is poised for a comeback and can offer financial rewards to involved companies"
Novartis' acquisition of The Medicines Company (for $9.7 billion for Inclisiran, an LDL-C lowering drug) late last year sits well with the last line above that I highlighted in red.
https://healthadvancesblog.com/2020/07/16/is-cardiovascular-rd-ready-for-a-comeback/
New Modalities in CardioVascular Drug Development
------------------------------------------------------------------------------------------------------------------------------------------------
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 inhospitalizationsfor heart failure andcardiovascular death.
2. Trial data supported the benefit of Entresto in reducing worsening heart failure (total heart failure [HF]hospitalizationsand 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 resultsdidnotreach statistical significance for reducing morbidity and mortalityamong 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 wasNOTmet, 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 (I do not now if Inclisiran or Entresto were given to patients in MESO's CHF trial).
A highlight of MESO's REVASCOR is that there was a reduction in the incidence of STROKES (as well as heart attacks).
PS: My post is not financial advice. Please do your own research for your financial decisions.
(20min delay)