Sunday, August 04, 2024 7:11:56 AM
Not sure if you mean in terms of proving efficary or safety in regards to low absolute numbers.
While it's perhaps a fully relevant comparison looking at Karuna from their two phase three 5 week trials they had around 94 dosed completers in emergent 2 and around 81 dosed completers from emergent 3 p3 trial. Also a phase 2 trial with around 60 dosed completers so in total that is around 235 who took their drug and completed the trials. Shizophrenia tend to have high withdrawl rates around 70% completion even in only 5 weeks.
For Blarcamesine 2b/3 trial they had around 191 who finished trial on the drug plus 25 who finished the 57 week 2a study (out of 32 who started) then that's around 216 who have taken the actual drug and completed the trials.
This is just completers obv in regards to overall numbers for both companies who have taken the drug are higher (if ignoring that they didn't complete) but still shows evidence in the sense of no deaths from drug as there was with the MABS.
Then in regards to safety you can add all those who took Blarcamesine for PDD and for RETT which would take the numbers who have completed trials on Blarcamesine to prob over 350. So looking at it this way Blarcamesine has more people who have taken the drug than Karuna has their drug and for much longer trial periods. Obv Karuna not approved yet but were bought for $14 billion based on their one drug so someone clearly has confidence.
Shortly as-well also those who were on placebo in 2b/3 who moved onto the drug for the to be relesed OLE so more dosed data.
While it's perhaps a fully relevant comparison looking at Karuna from their two phase three 5 week trials they had around 94 dosed completers in emergent 2 and around 81 dosed completers from emergent 3 p3 trial. Also a phase 2 trial with around 60 dosed completers so in total that is around 235 who took their drug and completed the trials. Shizophrenia tend to have high withdrawl rates around 70% completion even in only 5 weeks.
For Blarcamesine 2b/3 trial they had around 191 who finished trial on the drug plus 25 who finished the 57 week 2a study (out of 32 who started) then that's around 216 who have taken the actual drug and completed the trials.
This is just completers obv in regards to overall numbers for both companies who have taken the drug are higher (if ignoring that they didn't complete) but still shows evidence in the sense of no deaths from drug as there was with the MABS.
Then in regards to safety you can add all those who took Blarcamesine for PDD and for RETT which would take the numbers who have completed trials on Blarcamesine to prob over 350. So looking at it this way Blarcamesine has more people who have taken the drug than Karuna has their drug and for much longer trial periods. Obv Karuna not approved yet but were bought for $14 billion based on their one drug so someone clearly has confidence.
Shortly as-well also those who were on placebo in 2b/3 who moved onto the drug for the to be relesed OLE so more dosed data.
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