Replies to post #133566 on Anavex Life Sciences Corp (AVXL)

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“A daunting conclusion from this review of clinicaltrials.gov is the large number of participants required to conduct the trials. Registered preclinical AD trials will require 8239 participants; trials of prodromal or prodromal/mild populations require 22,009 participants; trials of mild to moderate AD dementia are forecasted to require 22,253 participants; and trials in severe AD dementia will require 588 participants. In total, 54,073 participants will be required to complete the current AD trials. Trial recruitment is among the slowest and most expensive of all aspects of clinical trial conduct. The recruitment of such large numbers of participants will represent a substantial challenge to the system, and reforms are necessary to accelerate clinical trials and enhance recruitment “


“A recent analysis of AD drug development showed that it takes on average 13 years for a candidate treatment to move from laboratory to FDA review and 10 years for an agent to navigate the clinical development period from start of phase I to end of FDA review [37]. This means that under current circumstances, an agent must now be in phase II to possibly be approved by 2025.

http://www.sciencedirect.com/science/article/pii/S2352873717300379


“. In AD, there are few biomarkers given the myriad of affected processes; there are only a small number of target engagement biomarkers capable of giving an early readout on proof of pharmacology; there are no surrogate markers known to predict the clinical outcome; and no validated outcome biomarkers have been shown to correlate with clinical outcomes in a trial in support of disease modification. These circumstances disadvantage AD drug development and increase the failure rates, especially for proposed DMTs.

Symptomatic agents are an important part of the AD drug development pipeline. There are four cognitive enhancing agents and no agents targeting behavioral symptoms in phase I clinical trials. Phase II has eight cognitive enhancing agents and seven behavioral agents in trials, whereas phase III has three cognitive enhancing agents and seven behavioral agents. Together there are 15 cognitive enhancers and 14 agents targeting neuropsychiatric symptoms in the pipeline. This comprises 27% of the AD drug development pipeline.