Hi Wayoutback,It’s not an exclusive collaboration, that’s...

Hi Wayoutback,

It’s not an exclusive collaboration, that’s correct & nor is PromarkerD simply validated to a single medication to treat CKD/DKD, so really with the progress of recent medications to treat these chronic diseases in the last couple of years only with SGLT2i & others, it’s to our benefit it’s not exclusive at present. I’m actually excited to see these research results, but regardless of a CDx, moving forward with FDA approval now, & across the board, regardless of treatment. It’s been a while coming!

It’s also been validated to predict DKD in diabetics up to 4 years before onset of DKD, so that really is the biggest win in this test, so not only are lifestyle, diet modification & medication interventions to prevent or slow the disease are able to be instigated earlier on.

Ph1 on the post-hoc CANVAS study was validation of PD, both in patients on treatment with Cana & placebo.

Ph2 is patients on treatment & looking at whether PD has the ability on treatment with Janssen’s drug candidate to look at risk scores, (ie is the drug working in this patient, has their risk score gone down since commencing treatment, and also looking at CVD indicators as well) as Canagliflozin also has an approved indication for this in the USA.

This wasn’t the case when we first were aware of the collaboration with Janssen. That came later, but in diabetic patients, it’s all connected (CKD/CVD & stroke risk).

A really big thing now is personalised medicine, & that’s where CDx comes in. CDx are mostly approved for cancer treatments with the FDA & I think this below article on personalised medicine explains things well:

https://www.google.com.au/amp/s/newseu.cgtn.com/news/2021-02-27/Roche-Pharma-CEO-Most-health-challenges-are-unrelated-to-COVID-19-YcyosQJN8Q/share_amp.html

It’s about giving the right medication to the right patients & at the right time. This is an article in regards to Roche Diagnostics, but you can translate that information to chronic & complex diseases such as diabetes also. It’s not just about expensive gene therapies anymore.

Personalised medicine is the way of the future in putting patients first & whether the technology available is able to assist Physicians in choosing best therapy for individual patients & monitoring that ongoing.

There are ethical considerations such as risk vs benefit, side effects & cost of the drug to patients & payers, whether that be Govt subsidised or Private & essentially, whether the drug will be helpful or not at that point in time. For PromarkerD, I think this current Ph2 study will help to look at starting patients earlier, and not when DKD/CKD is already established, evident by blood markers/biopsy that are currently available diagnostic tests, they are not predictive.

I think we also need to remember it was Janssen who approached PIQ, & our research collaboration has moved to a second (complicated) Phase with results impending. There could be more, post market & approvals studies are ongoing, but I think that considering now what we are doing with Janssen, they have a fairly large interest in PromarkerD, & to be honest, probably the rest of our pipeline as well, especially Endometriosis & Oesophageal Ca, as 2 potential more CDx, plus they have a big interest in global health endemic disease (HIV/TB, & these really are problems in developing countries, if you live in Australia, you’ll be OK & have a life expectancy about the same as a person without it).

Giardia cuts it for this as well in developing countries, especially, but transmission from infected pets to humans also an issue in Westernised countries & sometimes in our water supply (boil water alerts) after heavy rain.

@Bella, yes roller coaster ride continues along, but the dips & highs are getting higher it appears.

GLTAH