$RLFTF Zyesami DD (opinion) by Sparks Yh-0: Dr Fauci
Congratulations to anyone who made it here when they heard Dr. Fauci talk about the NIH trial involving Zyesami.
Just a quick rundown on the complicated family that this therapeutic belongs to:
First Zyesami is a US-based trade name for Aviptadil, a synthetic form of Human Vasoactive Intestinal Polypeptide (VIP) - there are many others - RLF-100 being one that Relief Therapeutics uses for outside the US.
Relief Therapeutics is a public company based in Switzerland (RLF on the Swiss Six, RLFTF on the OTC) and owns the patent for aviptadil formulations - they partnered early on with NeuroRX (US based, not currently public but planning to go public through a 'combination' with Big Rock Partners (BRPA, BRPAW, BRPAR, BRPAU) some time in May) to have a US based partner to take it through clinical trials. NeuroRX and Relief have a collaboration agreement where NeuroRX is responsible for the US, Canada, and Israel and Relief is responsible for rest of world - they split the profits in all cases.
NeuroRX's main responsibility has been to guide Zyesami through the necessary trials to get FDA approval starting with an EUA due to the covid pandemic. Since the FDA is very stringent on drug approvals, they wanted to start trials in the US and get approval here first before looking at pushing this out to other countries globally since many of these countries rely on the US FDA for drug approval. They started with an EAP last fall and had some very encouraging results. Dr. Javitt applied for an EUA last fall based on the EAP data that the FDA found encouraging but since it wasn't attached to a blinded/placebo based trial, they said to finish that and come back with those results. It seems that Dr. Javitt applied knowing it would initially not meet trial criteria but would put it on the radar for the FDA keeping them in contact and making it easier once the results from the blinded trial were out.
This double blinded study for an intravenous version of Zyesami finished up recently and we learned that it met all of its primary and secondary endpoints when they shared top-line data. There is a paper out now for peer review - you can find links on this board if you dig a bit or someone could post some links in the reply to this message if you are so inclined. The data is in the final stages of being consolidated and it is either about to be given to the FDA. Zyesami was given a fast-track for FDA approval so the time needed for approval should be shortened.
Beyond EUA which is emergency use authorization, Relief and partners have started additional studies with various groups like NIH, I-spy, etc. for both intravenous and inhaled versions of aviptadil as in order to get full drug approval (NDA) you have to have multiple studies and a good safety database to get full drug approval. On a side note, most people seem to think that the intravenous results will get us the EUA since it was targeting the most critical patients when everyone else was going after moderate to severe, and in the door, but that the inhaled version is the holy grail for this drug for many different lung-related indications way beyond covid.
In the meantime, Relief has partnered with Acer Therapeutics (ACER) to start building a pipeline of drugs beyond Zyesami for some very strange drugs for rare conditions, and they have also been busy ensuring they hold all the patents for aviptadil-related formulations by essentially acquiring all the shares of Advita Life Sciences as they have been working on inhaled formulations of aviptadil as well.
LIke in all dysfunctional families, once that first trial was done and all the endpoints were met and this thing became real, Relief and NeuroRX have been squabbling a bit over money but these are smart people that will get this worked out.
This is my interpretation to give you a quick overview, but if you look at the Relief Therapeutics and NeuroRX websites, you can find all of this info in their press releases.
