PMN 310 Clinical TrialSorry, but I don't care about Acumen's two year delayed Phase 1 clinical trial on 62 patients. It has provided no read outs.
PMN 310's IND apllication will be made in December. After 30 days it will automatically be approved with no FDA letter. So, Promis will be dosing in January or February 2023. 3 months of placebo control to assess ARIA-E, brain bleeding risk. Then a nine month period where doses are ramped from 2.5 to 60 mg. I don't believe any previous ALZ climical trial, got anywhere near a 60 mg dose. Oh, and by the way Promis will be releasing blood biomarker readouts for 5 different ALZ biomarkers.Never done before. Promis has developed a proprietary biomarker test. Every month there will be readouts in an "open label trial". This is a bold move in my opinion, and there will be a lot of attention on these readouts. I believe they are calling this 1b of the phase 1 trial. Promis has previously asserted that this proposed clinical trial structure may accomplish Phase 1 and 2 goals. The fact that they have indicated they may do another financing in the phase 1b trial, indicates to me that they anticipate positive biomarker results that indicate that PMN 310 is having a significant impact.. It is even possible, that PMN 310 may be reversing the disease. See page 23 of the corporate presentation.