Hi Jason,
Not a silly question at all mate.
We were advised at the commencement of the trial that there would be no preliminary readout (so no unblinding of trial data during the trial, 1/2 way through), and I think that may have been due to the crossover design of the trial. So this is why it feels so long without news.
The only time it would have been unblinded is for Data Monitoring Safety Board Review (DMSB) (but that is an independent review).
(All patients were randomised to 2 treatment groups, who then received drug or placebo & then crossover. So all patients were treated with DMX-200 within 1 of 2 treatment periods).
IQVIA is the contract research organisation (CRO) managing the trials, so each site has a trial monitor to oversee things (they are blinded too).
If you ever want to know about trial design, look at the trial posting on the clinical trials websites:
https://clinicaltrials.gov/ct2/show/NCT03627715?term=Dimerix&draw=2&rank=2This is the link above for DKD. If you look at trial design & blinding/masking, it’s a double blind (so neither the investigator nor the patient knows if they are receiving the drug or placebo). It’s quadruple masked, and this is to avoid bias in the trial data & ensure trial integrity. (patient, care giver, investigator & outcomes assessor).
This article below is a pretty good explanation to understand what blinding & masking is & why it’s necessary.
https://www.researchgate.net/publication/315476836_Blinding_in_Randomized_Controlled_Trials_What_researchers_need_to_knowI hope that reading is helpful Jason, if you are investing in biotechs & scrutinising how “watertight” a Trial’s integrity is likely to be in results, when investing. No guarantees there, but it’s better to know what you are looking at, or it’s all just gobbledegook isn’t it, like mining technical stuff is to me, NFI lol.
I think DXB would have a fair idea with “multiple” patients from current trials remaining on DMX-200 post treatment period also & the reassurance from the DMSB that the drug is safe & advised continuation of the trial without change.
If there was no benefit in efficacy in a trial at this stage, they would have advised the trial be halted on the grounds of futility, which is an ethical consideration for patients.
Not long to wait now for results & it’s only natural to question your investment & your strategy at such a crucial time, especially with one trial (first to complete Ph2A) being a relative unknown, but the discussion on Ph2A data & the “other” patient group & the change to the inclusions in current trials for CKD/DKD diagnoses has made me feel more comfortable about that.
The COVID-19 REMAP-CAP trial was a pleasant surprise & a very interesting one.
The kidney disease trials are at the foremost interest though for Dimerix, the recent news a big added bonus.
The trial protocols are public on the REMAP-CAP site as well as for each drug included in different arms.
Obviously we are not there yet going through Ethics for the new inflammatory arm. This trial is fairly unique in that new trial sites can be added in COVID-19 hotspots globally, & treatment data will be disseminated in order to treat COVID-19 patients in the most efficacious & timely way. Not like a normal trial where you may be looking at many months to years for data collection & results, we don’t have time for that with COVID-19. So IF DMX-200 is working for ARDS, we may see news on how it is faring in real time, sooner rather than later.
The trial has recruited >1000 Covid-19 patients to date. Australia alone (NHMRC) has dedicated >$4,000,000 towards this international trial & its a WHO approved multinational trial with both Govt & private funding. So watch that space also.
GLTAH
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