The company is keeping its eye on the prize as it builds towards longer-term studies for its DMX-200 treatment solution to DKD.
Biotech company Dimerix (ASX:DXB) has a number of irons in the fire as it moves through multiple Phase 3 trials this year.
At the same time, CEO Nina Webster is also staying focused on progressing the lucrative long-term opportunity for the application of its proprietary drug, DMX-200, in the treatment of Diabetic Kidney Disease (DKD).
Speaking with Stockhead recently, Webster provided some important details about the size of the DKD market and how the development process works to build viable treatment options.
Market opportunity
On a macro level, the need for viable DKD treatment solutions is particularly prevalent as global rates of diabetes continue to rise.
In the US market alone, around four million prescriptions to treat DKD are issued each year, Webster said.
Breaking down the size of the addressable market, Webster said that it is estimated more than half of those patients would still require additional treatment solutions to delay kidney failure.
That segment of the market is where DMX-200 is targeted, because it acts as an adjunct therapy to improve the effectiveness of existing treatments.
On average in the US, drug treatments in the diabetic kidney space retail for around $US500-$US600 per month, Webster said.
That equates to ~$US6,000 per year from an annual pool of around two million patients, resulting in an addressable market opportunity of more than $US1 billion in the US alone.
“That’s real data based on prescriptions that are going out the door,” Webster explained.
“The exciting thing for us is that our Phase 2 trials (last year) showed the DMX-200 treatment demonstrated a benefit as an adjunct therapy to existing drugs,” she added.
Testing time frames
The development pathway follows on from its promising Phase 2 trial last year, where DMX-200 demonstrated a clear additional benefit to patients with DKD.
In company presentations, Dimerix provided a breakdown of the Phase 2 trial showing results for patients in two separate cohorts – higher base levels of Albuminuria, and lower base levels.
Albuminuria is a condition caused by excess levels of protein in the urine, which is the primary indicator of kidney disease.
For patients with a higher baseline, 37 per cent showed a reduction in Albuminuria compared to the placebo at the end of the study.
While for those at the lower baseline, half of all patients saw Albuminuria levels drop below the level associated with DKD diagnosis at the end of the study.
Importantly, across the whole study, 30 per cent of all patients ended up below the Albuminuria threshold for diagnosis with diabetic kidney disease.
“Those are fantastic results for those patients,” Webster said. “And if you look at both the lower starting base line and the higher baseline, in all of them the base results are extremely promising.”
“Then if you combine those results with all of our testing data, what it shows is a trend (in DKD) that’s continuing downwards at the end of each of these studies, with no impact of other medications such as SGLT2s on DMX-200 efficacy.”
And ultimately, what that provides is crucial evidence for the merits of “a longer study that would likely see greater protein reductions.”
In that context, the company is staying on track for its longer-term DKD development pathway, which has always been its strategy.
When it comes to the clinical trial process for new and improved DKD treatments, Webster said there are a couple of important points for investors to understand around time frames.
Firstly, because the diabetic kidney disease market is so large it means new treatment solutions are not typically given the benefit of accelerated approval times that drugs with an orphan drug designation get.
As a result, the development is more suited to longer, larger studies – which is exactly the kind of trial Dimerix is assessing for its next phase of testing.
In the interim, DXB is focused on an accelerated pathway for DMX-200 in the treatment of FSGS (focal segmental glomerulosclerosis, a rare kidney disease), which has orphan drug designation in the US and Europe and is moving towards Phase 3 trials by the middle of this year.
However, Webster reiterated that its DKD treatment hasn’t been put on the backburner.
“It’s not an orphan drug designation which means you have to follow the traditional drug development pathway. Typically, that means a longer study with more patients, which is quite normal,” she said.
She added that industry data shows a clear trend towards the capacity of longer trials to nullify placebo effects.
“If you look at other studies in kidney diseases more broadly reported in 2020, there seems to be a lot of consistency where a placebo effect was seen early on, and then it dissipates at the 12-16 week mark (of the study),” Webster said.
“That’s a definite trend consistent across studies, which indicates that a longer study will also mean that placebo effect will likely disappear.”
“So we are in active discussions with key opinion leaders in Australia, but also overseas in the US and Europe on designing what that study will look like.”
This article was developed in collaboration with Dimerix, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
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