RE: Evidence Please/Confused5 Sep 2021 13:11
ALB1
I'll do my best to answer your questions.
If you read through the results of the 2018 Phase 3 trial of Lupuzor you will see that there were two trial areas, one being Europe (including a special subset in Mauritius) and the other, the USA. The European cohort was much larger than the American one. In the European one the finding was that in patients with severe Lupus there was clear evidence of the efficacy of Lupuzor compared with the placebo. In the much smaller USA cohort, the opposite was true; if anything the placebo was more efficacious than Lupuzor. Very strange. I don't know why but it seems to me there was a ****-up in the selection of patients - were they really Lupus sufferers or merely showing similar symptoms to Lupus which has a wide range of symptoms making it difficult to diagnose.
18 months after this the research deal between Avion and IMM was signed; Avion was obviously persuaded by IMM that a properly conducted Phase 3 trial in the USA would produce the positive results that were found in the 2018 European part of the Phase 3 trial. Avion are not fools; they have a successful record of bringing drugs to the market after obtaining FDA approval and they were willing to commit $25 million to the new Phase 3 trial, more than double spent on the 2018 trial.
So the CEO of IMM is correct to claim that Lupuzor has been shown to work; what he didn't say was that this success in the large European patient cohort was negated by the failure in the much smaller USA patient cohort and led to the FDA negative view of the overall result.
Avion is a private company; it does not have to make known to the market any news which might influence the price of the share, whereas IMM has to make any such news known to the market, hence the long line of RNS announcements on the IMM and LSE websites. Avion only seems to inform shareholders of current success stories of its principal products already in the market.
As to the delay in starting a new Phase 3 Lupuzor trial, I think this can be attributed to two factors. The first is the Covid - 19 pandemic which led to pharma companies and state agencies such as the FDA concentrating their resources to the search
for new therapies and vaccines to treat Covid. The FDA were under tremendous pressure from the Trump adminsitration to give top priority to assessing various new therapies, including the efficacy of already approved drugs which were developed to treat other diseases like malaria and of the immune system. These included Trump's bizarre suggestions for treatment. I forget them all,but they included hydroxychloroquine for treating malaria, and bleach for cleaning lavatories.
At the same time, it seems as though the FDA wants to ensure that the debacle of the first Phase 3 trial involving American patients should not be repeated. Recent RNS announcements mention "productive discussions" between Avion and the FDA which led to the present situation where a small number (25) are being te