Moderators, feel free to delete this post if you do not feel it is relevant to IPIX.
Some of this info I gleaned from the "other" board but all posts there unfortunately have to be fact-checked. I did not re-post here or include verbatim as that could be a TOS violation. FWIW, the most insightful posts I found were a couple of Reddit posts, btw.
I included this info because I thought it relevant and informational for the Brilacidin trial for Covid-19. This is from the VIP/Aviptadil/ZyeSamir IV infusion blinded trial for Covid-19 conducted by NeuroRx / RLF (and no I am not touting it) and for results from preliminary summary data.
The ZyeSamir trial started in May 2020. It took until Dec 2020 to end enrollment. Monitoring of the last patient was concluded about a month ago after 60D. One thing that was apparent was that it was not easy to conduct this trial in the midst of a pandemic and the timeline change for the European trial for Brilacidin to Sep 2021 makes sense to me. In addition, some patients dropped out from the ZyeSamir trial (some likely because they figured out they were on placebo) so the planned trial enrollment went from an initial 144 to 165 to finally 196 (officially).
The primary endpoint for the ZyeSamir trial was resolution of respiratory failure which was not met from preliminary summary data. Survival at 28D also didn't show a statistically significant difference. Seems as if hospital ICUs have learned, and are now able to keep double the % of patients alive since early to mid-2020 when the survival was only around 30% with just SOC, i.e. SOC has improved considerably since early 2020, at least until 28D. Because there was no significant difference in mortality at 28D, the monitoring period was increased from 28D to 60D. SOC included Remdesirvir plus other treatments. These were for moderate to severe patients - with severe patients requiring some form of breathing assistance - as far as I can determine.
ZyeSamir (on the blood side of lung alveloi) was supposed to prevent replication of virus particles that attached to ACE2 receptors (on the air side of lung alveoli). This definitely had an effect as hospitalization durations were considerably reduced in the trial from the preliminary data so far released, so the secondary endpoint was met.
Given that Brilacidin is expected to kill off the virus particles - not just stop them from replicating - my hope is that hospitalization durations will be reduced even more compared to ZyeSamir's results. If the Brilacidin trial shows that the primary endpoint is met (and handily I hope) it will give Leo/IPIX a trifecta to present to BPs for licensing and a path to Brilacidin Phase 3 trials.
I have little medical knowledge and I have a question about how Brilacidin will deal with the virus particles in the lungs. This will not be an issue with a future inhaled form of Brilacidin I assume (at least for mild to moderate patients), but for now we only have the IV infusion for this trial. Anyone have a good idea how effectively Brilacidin - which is on the blood side of lung alveoli - will work against virus particles - which are on the air side of lung alveoli?
In addition can anyone comment on Brilacidin's effectiveness with severe patients? I suspect that for severe patients, there could be damaged blood vessels as well as damaged organs. Could Brilacidin help with recovery beyond clearing out the virus, reducing bacterial infections and inflammation?
Some of this info I gleaned from the "other" board but all posts there unfortunately have to be fact-checked. I did not re-post here or include verbatim as that could be a TOS violation. FWIW, the most insightful posts I found were a couple of Reddit posts, btw.
I included this info because I thought it relevant and informational for the Brilacidin trial for Covid-19. This is from the VIP/Aviptadil/ZyeSamir IV infusion blinded trial for Covid-19 conducted by NeuroRx / RLF (and no I am not touting it) and for results from preliminary summary data.
The ZyeSamir trial started in May 2020. It took until Dec 2020 to end enrollment. Monitoring of the last patient was concluded about a month ago after 60D. One thing that was apparent was that it was not easy to conduct this trial in the midst of a pandemic and the timeline change for the European trial for Brilacidin to Sep 2021 makes sense to me. In addition, some patients dropped out from the ZyeSamir trial (some likely because they figured out they were on placebo) so the planned trial enrollment went from an initial 144 to 165 to finally 196 (officially).
The primary endpoint for the ZyeSamir trial was resolution of respiratory failure which was not met from preliminary summary data. Survival at 28D also didn't show a statistically significant difference. Seems as if hospital ICUs have learned, and are now able to keep double the % of patients alive since early to mid-2020 when the survival was only around 30% with just SOC, i.e. SOC has improved considerably since early 2020, at least until 28D. Because there was no significant difference in mortality at 28D, the monitoring period was increased from 28D to 60D. SOC included Remdesirvir plus other treatments. These were for moderate to severe patients - with severe patients requiring some form of breathing assistance - as far as I can determine.
ZyeSamir (on the blood side of lung alveloi) was supposed to prevent replication of virus particles that attached to ACE2 receptors (on the air side of lung alveoli). This definitely had an effect as hospitalization durations were considerably reduced in the trial from the preliminary data so far released, so the secondary endpoint was met.
Given that Brilacidin is expected to kill off the virus particles - not just stop them from replicating - my hope is that hospitalization durations will be reduced even more compared to ZyeSamir's results. If the Brilacidin trial shows that the primary endpoint is met (and handily I hope) it will give Leo/IPIX a trifecta to present to BPs for licensing and a path to Brilacidin Phase 3 trials.
I have little medical knowledge and I have a question about how Brilacidin will deal with the virus particles in the lungs. This will not be an issue with a future inhaled form of Brilacidin I assume (at least for mild to moderate patients), but for now we only have the IV infusion for this trial. Anyone have a good idea how effectively Brilacidin - which is on the blood side of lung alveoli - will work against virus particles - which are on the air side of lung alveoli?
In addition can anyone comment on Brilacidin's effectiveness with severe patients? I suspect that for severe patients, there could be damaged blood vessels as well as damaged organs. Could Brilacidin help with recovery beyond clearing out the virus, reducing bacterial infections and inflammation?
3
