NEU neuren pharmaceuticals limited

Ann: Temporary pause in new enrolments for LAVENDER trial in US, page-83

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    Cuppa

    With reference to what I posted -

    Sarizotan works by stimulating serotonin and dopamine receptors. By replacing some of the missing serotonin in the brain and spinal cord, it is expected that the drug might help restore normal breathing rhythm in patients with Rett syndrome.

    The primary endpoint of Newron’s (likely pivotal) trial is the reduction in respiratory abnormality in patients with Rett syndrome, measured over 24 weeks. This will be assessed as the percentage reduction in the number of clinically significant (>10secs) apnoea episodes per hour while awake, measured using an ambulatory home monitoring system.


    There is no suggestion that Newron has been testing receptor levels.

    The first paragraph above is simply a description of the believed mechanism of action of sarizotan. I have relied upon a UK NHIR Evidence Briefing document (see link below) for this description.

    As stated in the second paragraph, the primary outcome Newron has been testing in their trial is the number of clinically significant (>10 secs) apnoea episodes per hour while awake. Cardio-respiratory monitoring using a specialized ambulatory data acquisition system, the BioRadio™ system, has been used to measure these apnoea episodes.


    http://www.io.nihr.ac.uk/wp-content...an-for-Rett-syndrome-V1.0-JU2018-NON-CONF.pdf

    https://hotcopper.com.au/threads/a-comparison.3215975/?post_id=22484597
 
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