I think we are in with a very good chance of success of predictive monitoring of patients while on treatment with Invokana (ie does the patients risk score for PD go down while on treatment). They are also looking at cardiovascular measures as well. Invokana is approved in the USA for both DKD/CKD & CVD. In the EU for DKD. I dug up the ANN in regards to the ongoing collaboration with Janssen FYI:
We should probably remember that in validating PromarkerD in the first Phase with Janssen, that patients were on either placebo or treatment with Invokana & PromarkerD was predictive of kidney function decline in both cohorts.
Richard had warned at the time that this would be a complex study with a lot of data & if we are seeing prediction of cardiovascular events also in diabetes this will be explosive.
There are now 4 top 10 Pharmas with SGLT2i (Janssen/J&J, AstraZeneca, Eli Lilly & Boehringer Ingleheim) vying for a market share in DKD/CKD/CVD on successful large post market clinical trials in these indications & priority review with FDA in or already approved.
They all have similar results from clinical trials across preventing ESRD & cardiovascular events in diabetics.
So having a test that is accurately predictive for a Physician to see how their patient is travelling in regards to risk scores on treatment with a SGLT2i, will have an added advantage & potentially not just in nephrology but cardiology as well, it’s all connected.
Potentially the test could be used across the whole drug class of SGLT2i which is SOC in these indications, so we really want this validation as a CDx for Invokana regardless.
There is also the patent in the USA covering drug development using PromarkerD biomarkers, so covering the whole package really.
From memory, I think Richard did say there was some hold ups during COVID-19 & this study was due for completion in Nov 2020, & now we are almost in March 2021. Not complaining, it’s a given in biotech investing & clinical trials/studies, but it’s gotta be very soon guys & gals!
GLTAH
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