The IMP under study in this trial was a monoclonal antibody that has been shown in preclinical studies to suppress cerebrospinal fluid concentrations of extracellular tau (eTau). eTau has been implicated in the spreading of tau pathology as it disrupts synaptic activity in vitro and hence is presumed to have a similar effect in vivo.
However, working with monoclonal antibodies as therapeutics presents many challenges. For example, the IMP in this trial is only stable for 24 hours after preparation. Even minor delays and disruptions in delivery of the IMP to patients can compromise its quality, and this is exacerbated when the treatment needs to be shipped across different time zones from a central pharmacy, as was the case in the USA. Moreover, scheduling appointments – never mind keeping them – becomes a logistical challenge for all involved when different time zones need to be factored in.
To find out how these challenges were addressed, download the available case study.