Advances in treatment of Alzheimer's disease have been confirmed in recent months.
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Prana Biotech provides update on its clinical development program for Alzheimer's disease; confirmed the top line finding that there is a very promising trend towards the preservation of brain volume (as measured by MRI) in PBT2 treated patients compared to placebo patients
4:11 PM ET 7/17/14 | Briefing.com
Co provided an update on its clinical development program for Alzheimer's disease.
The IMAGINE trial top-line draft results were released on 31 March 2014. Further sub-analyses of the top line imaging data have been performed, including PiB-PET, MRI and FDG analysis of the effects of a once daily, 250 mg dose of PBT2 over 12 months. IMAGINE enrolled 42 patients, 27 in the PBT2 group and 15 in placebo. The primary objective of the IMAGINE trial was to explore whether amyloid burden, as measured by PiB-PET would decrease in participants treated with PBT2 relative to placebo. However, in contrast to published literature, the average amyloid burden in the placebo group fell during the trial. Prana conducted a sub-analysis to better understand the behaviour of the placebo group and what can be learned in the trial about the utility of such exploratory biomarkers for future trials. Professor Masters noted that the starting amyloid burden level (baseline) in the PBT2 treated participant group had an important bearing on the decrease of amyloid over time in that participant (p=0.035), whereas there was no such correlation in the placebo group. Prof Masters further investigated the response of participants with baseline amyloid burden levels above and below the mean for the IMAGINE cohort ( SUVR of 2.5). He showed that in the subgroup of PBT2 treated participants with a baseline of SUVR above 2.5, there was a significant decrease in amyloid burden that was not observed in participants on placebo nor PBT2 participants with a SUVR less than 2.5. Separately, Prana has confirmed the top line finding that there is a very promising trend towards the preservation of brain volume (as measured by MRI) in PBT2 treated patients compared to placebo patients.Thirty three patients elected to join the Extension trial and of these, 30 remain on the trial. Of those participants, 21 have now been identified as being randomized to the PBT2 treatment arm in the IMAGINE study. Of these, all 21 patients have completed 14 months of PBT2 administration, 20 have completed 18 months of PBT2 administration and nine have completed 21 months of PBT2 administration. Co is pleased with the continuing safety profile of the drug. The data safety monitoring board has met a further two times and has not expressed any concerns in relation to adverse events. |
