Invokana was slapped with a black box warning in 2017 for an increased risk of lower limb amputation, however in recent trials, there was no increased risk found between placebo & treatment groups with Canafliglozin. All SGLT2 class of drugs have very similar risk of side effects, but this has damaged the safety profile of Invokana (Canafliglozin) & now we are seeing other Big Pharma catching up in approved indications for cardiovascular & kidney disease.
Our current (Ph2) of analysis is looking at patients on treatment with Invokana & looking at improvement of kidney function on treatment & improvement of PromarkerD risk scores, so yet another important validation study for us, in looking at a CDx for the drug with the FDA.
The renal effects of treatment with Invokana are already known from CREDENCE, CANVAS & sub-group analysis & this gained Janssen approval for these indications.
What I find frustrating is that our test has been validated for risk screening for DKD in multiple trials, including the recent ADA co-presentation with Janssen, it could now be used to assist in the screening & diagnosis of millions of patients, particularly EU, where all our regulatory approvals have been granted & Invokana has recently been approved for DKD. I am very hopeful of some news here soon.
DXB had also reported they were utilising PromarkerD in CKD/DKD Trials in 2018 & obviously these trial numbers are nothing compared to >3000 in recent analyses, but this still holds some weight for the test, especially for FSGS, a designated rare kidney disease, for which DXB has Orphan Status with the FDA, results due before end of July (not sure if PromarkerD was used in this one) but yes to DKD trial to complete last patient dosing in July 2020.
COVID-19 has worsened the situation with screening for people with diabetes for CKD with the need for self isolation recommendations for high risk groups (Diabetes in particular in the UK, following data on mortality & recommendations released by the Govt, 1/3 of deaths in the UK had a diagnosis of Diabetes), and there have been recent efforts by MundiPharma & Napp Pharma in funding DKD research for screening & diagnosis of DKD, prior to the announced EU Regulatory approval for DKD for Invokana.
A lot of attention for the RenalytixAI test, but I guess they are banging the tin can for their NASDAQ listing & the proof remains in the pudding for PIQ, even though it appears to be in the slow cooker right now.
We have moved to the next stage in analysis for a CDx these things take time. I’m sorry for my frustration: a case of “But look at what RenalytixAI are doing with where we were at 2 years ago” a much bigger MC mind you. This could be us soon, so I guess you can look at both sides of the coin
PIQ Price at posting:
42.5¢ Sentiment: Buy Disclosure: Held
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