Yep, when people have bad side effects or are not getting decent results,
Several have left other Trials.
Never said all always leave.
People will worry about their own health first and do what is best for them.
More data can be more markers, cell counts and other data,
All effects are not always known beforehand,
Or the duration of how long such effects last,
Or how long they last in post trial analysis.
Previous Results Data demonstrated that BIT225:
* Targets HIV-1 in blood reservoir cells, and significantly reduces virus in these cells
* Crosses the blood-brain barrier, opening up the possibility of treatment of AIDS-related dementia
* Reduces myeloid-specific immune activation markers during trial
Data from the BIT 009 Phase 2 trial also showed that BIT225 induced:
1. Statistically significant reduction in immune activation (sCD163)
2. Significantly significant changes in specific immune cell markers i.e. BIT225, a small molecule, direct-acting antiviral drug has induced vaccine-like effects
• Evidence of immunological benefits not seen with any other HIV-1 therapies
• Demonstrates clear benefit over and above approved anti-HIV drugs
This is also testing 6 months of treatment,
Previously it was half that.
While someone could guess the results,
It must be done by proving the results with real data which cannot be guessed or estimated.
Data such as:
*CD163 change from baseline by Treatment Group Mean during 12 or 24 Weeks of BIT225 or placebo treatment with ART.
*Activated CD8+ cell numbers proportional to baseline during 12 or 24 Weeks of BIT225 or placebo treatment with ART
*Activated CD4+ cell numbers proportional to baseline during 12 Weeks of BIT225 or placebo treatment with ART.
*Plasma HIV-1 RNA change from baseline (median) during 12 Weeks of treatment with BIT225 or placebo and ART.
These Trails also include groups that had not yet started treatment with ART,
And those who has already been receiving treatment with ART.
The BIT225‐010 trial included people newly diagnosed as being HIV‐1 positive and commencing anti‐retroviral treatment (ART) for the first time.
The BIT225‐011 trial enrolled people who had been taking ART for several years but had not achieved full immune reconstitution.
Then there's also the Phase II Covid Trial to determine if 7 days of treatment with BIT225 commenced within 3 days of onset of COVID-19 symptoms results in reduction in SARS-CoV-2 blood viral load, clinically favourable changes in viral, inflammatory and immune activation markers, as well as improvement in clinical symptoms of COVID-19.
So no they cannot really just guess how much data they will have.
The more different ways of proving BIT 225 works the better.
The more data,
The more proof to potential Partners.
That can only be a good thing !!!!
