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I saw that Neuvivo recently submitted an NDA for

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Post# of 155043
(Total Views: 567)
Posted On: 10/30/2024 10:04:15 AM
Posted By: ohm20
Re: mfglola #147597
Quote:
I saw that Neuvivo recently submitted an NDA for ALS. They are targeting inflammation with a formulation of sodium chlorite.



The initial rationale for their drug was that it modified ROS producing macrophages to an anti-inflammatory state. It didn't seem to directly do that to any extent given the failure during the trials. Their post hoc analysis looked at only those 40-65 years old with high levels of CRP. Of course those with higher inflammatory markers are more likely to benefit if the drug has effect. In those specific parameters the drug did show benefit but just over statistical significance. With a larger number of patients that may improve or not.

What is a bit strange is that they now posit that the drug works by limiting gut epithelial cell leakage of gut bacteria (leronlimab does this by blocking CCL3). Gut bacteria leakage would lead to an over-reactive inflammatory state. That complete pivot in mechanism of action shows why post hoc analysis is usually not trusted.


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