Roche have temporarily halted recruitment to the GENERATION HD1 clinical trial (for the huntingtin lowering or gene silencing drug RG6042, initially developed by IONIS). They have decided to do this because analysis of data from the group of people who took part in the phase one trial for the drug and who continue to receive it may suggests less frequent dosing is possible.
The trial was designed to include a placebo or dummy treatment group, of approximately one third of the trial participants. This group is absolutely necessary to cope with the placebo effect – the fact that participating in a trial makes people feel better, and even function better, even if the drug doesn’t work.
The other two thirds of the participants were intended to be split into two groups, both receiving the active drug. Half of the treated group would receive the drug every month, and the other half every other month. This part of the clinical trial has not changed.
Roche has announce they are adding a third ‘arm’ to the trial in which participants will receive treatment of the drug just three times in a twelve month period.
Roche are being quite tight lipped about the reasons for this, but it seems the data being collected from those still receiving the drug has given them enough confidence to explore extending the interval between doses.
It is exciting news because, if this approach proved successful, it would be a step towards a manageable and much more affordable way of treating HD.
Our friends over at HD BUZZ have written an article about the trial change.