Thats a nice thought but unfortunately running close to a dozen separate phase 1, 2a and 2b trials with various parameters doesn't equal one phase 3 trial. 1 + 2 + 2 + 2 + 1 + 2 + 2 + 2 ≠ 3 or anything close to it. That would be like saying that I did year 12 five times so that must automatically get me a uni degree. Its got nothing to do with how many people have been dosed in total with the drug, its a matter of what has been proven for a specific treatment proposal.
Of the 11 BIT225 trials:
- At least 2 were simple phase 1 safety trials to prove the compound was unlikely to cause more harm than benefit.
- At least 3 were to treat HCV patients.
- At least 1 were on HIV/HCV co-infected patients to see if there was a niche for BIT225 in that difficult to treat cohort
- At least 4 have been specifically targeting various HIV cohorts to find where specifically BIT225 may find its niche
- Only 1 against Covid
So the point of a phase 3 trial is to prove via a large scale representative test that your proposed drug will provide quantifiable benefits to the specific cohort of people infected with your target virus with limited side effects and with appropriate duration of followup monitoring to ensure this to be the case. Given this:
1. We can't really count patients treated for HCV towards any hypothesis about how BIT225 helps HIV patients can we? Likewise we can't count patients treated for HCV or HIV in any statistics about how BIT225 help Covid patients can we?
2. Most of these trials have not only been targeting different viruses but also different target cohorts within these target patient groups. Statistics about the effect on a co-infected cohort are largely meaningless to other cohorts.
3. In most trials patients are not only being treated with BIT225 but also with other drugs which they are already on keeping them alive. We can't just add all the data together into a soup and draw meaningful conclusions from it because different patients in different trials and different cohorts with different viruses (or even combinations of viruses in some trials) are all on different combinations of drugs in different doses. Even the dose of BIT225 given in different trials varies.
4. BIT225 has been improved over time so data from trials prior to 2016 won't align well with data from subsequent trials since the formulation was changed as was the delivery mechanism. Both were improved which is also why they went back and ran new phase 1 safety trials.
The collection of data to date has however helped them understand a little more about how BIT225 may help in various situations, over what timeframes, and in what doses. BIT225 does appear to be a cure against HCV given previous phase 2 trial results but unfortunately for Biotron and its shareholders other cures made it through phase 3 and got commercialized before Biotron got there so that avenue has sat dormant for many years now.
When Biotron (or some other company who might license it) have decided on their target market a phase 3 trial will be designed specifically for this. With many viruses like HIV, HCV etc such a trial would not only include BIT225 but some combination of other drugs which is the case with current trials and previous trials. It will be of considerably larger scale (as per your quote) than any trial run to date and it will most likely be run and funded by others who have the ability to get it approved and commercialized.
Let me be clear. No trials run to date negate the need for a phase 3 trial, nor do participants from previous trials count towards a phase 3 trial. Likewise a phase 3 trial for HIV won't mean they can just start offering BIT225 as a treatment for Covid or anything else.
