I had typed quite a lengthy post in reply to you yesterday, but it disappeared while copying links & I ran out of time.
I see that you guys have already had some discussion. I think that the similarities in our trial designs are due to Regulatory requirements from the FDA. If you go back, I think from memory that has been discussed some time ago in Dimerix presentations on the ACTION trial, that is why.
Also please note that Prof Heerspink headed up our medical advisory board, a well renowned trialist in CKD so I would trust in his advice as well as the meeting outcomes with the FDA. He is an author on Travere’s IgAN interim results paper for which they received Accelerated Approval from the FDA, followed by a licencing deal with Vifor (now CSL) outside of the USA.
I hadn’t yet read the paper for FSGS, need to find my log in, but did read Travere’s announcements on late breaking presentations at ASN 2023. Link here for others who may be interested:
The FSGS trial is on a trial extension offered to patients (ethical) and they did see some excellent improvement in kidney decline & Proteinuria, 50% vs 32% for SOC (which is a known number over many studies for ARB with max dose Ibersartan). I believe they may still get approval even missing the eGFR slope in a rare disease with no cure (even transplants fail).
We also have preclinical work showing DMX-200 is potentially synergistic & complimentary to Spartensan as it is to ARB, so it’s been made quite clear that we aren’t in competition to a potential new gold standard replacing ARB (Ibersartan).
My interest in following Travere’s journey is because there is not a lot in this space to look at & I am still amazed at our incredible progress for a small Aussie biotech in a global Ph3, with all current sites recruiting. I am disappointed Travere didn’t meet their endpoint in eGFR slope, but I believe that all is not lost in this indication for them.
They achieved that it IgAN another Rare kidney disease. Yes that did play on my mind a bit, but we know that that the length of time patients are on treatment can make a difference, so there is a risk we may not make Interim analysis for Accelerated Approval but one I’m will to take.
Take care all & I wish Travere all the best with their study extension in FSGS. It wouldn’t be happening if there wasn’t benefit to patients, and there is.
DXB Price at posting:
14.0¢ Sentiment: Hold Disclosure: Held
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