apologies for the tag, reply function is very mysfunctional tonight on HC, I almost gave up!
as you would know, the trial design was different from previous for DMX-200 so we saw an anomaly of placebo effect of 12% and this was confirmed recently in both FSGS & DKD to have treatment order affect in both trials, meaning that the drug may have had longevity in an anti-inflammatory effect that lasted beyond the washout period & even potentially changed the course of disease.
Did the market think much of this? No.
It’s been confirmed on top line results that patients over the 57mmol/L ACR had statistically significant results (placebo adjusted for that 12%). We have not received the sub-analysis yet, so it’s still really interesting.
But we are not here to talk about that, other than Dimerix has a collaboration going with PIQ in this current trial, & if DMX-200 is licensed, then an option to licence PromarkerD as well.
I think the risk of investing in Biotechs is that you may receive poor trial results, and I’m not talking about DXB here, or PIQ. I think ‘robust’ is a very good word to describe the soundness you want from clinical trials & the stability and clinical knowledge & experience to design trials & conduct them. I see this in both PIQ & DXB. You see some absolute doozies, so a good comparison.
The market could change it’s mind anytime soon on both stocks..
Your question asking about predicting DKD, renal decline while on treatment with Canafliglozin & PromarkerD: I think we will be Ok there. It’s a slippery slope of eGFR into ESRD without treatment. If we can assess & predict the need for treatment earlier on & also to predict what will happen down the track & treatment ameliorates or prevents that, then a good thing (in placebo vs treatment large clinical trials). There are new treatment guidelines out to “treat to mitigate risk” in the USA, as recent studies have found that the younger people who are diagnosed with Type 2 DM have more risk factors for DKD/CVD. So serious health events may occur in their 40’s not 60’s. From prior ANNs, DKD/CKD results on Ph2 Canafliglozin should be out soon.
It’s important to remember that in the USA, Canafliglozin has DKD and CKD indication plus CVD on top of glycaemic control. Europe it’s DKD on top of glycaemic control. If I’ve missed anything please let me know.
A personalised tool to help users track selected stocks. Delivering real-time notifications on price updates, announcements, and performance stats on each to help make informed investment decisions.
(20min delay)