Roche has picked up PRIME (PRIority MEdicines) designation in Europe for its investigational medicine RG6042 for treating people with Huntington’s disease (HD).
RG6042 has demonstrated its ability to reduce the toxic mutant huntingtin protein (mHTT), believed to be the underlying cause of HD, in a Phase I/IIa study.
PRIME is a designation implemented by the European Medicines Agency to support data generation and development plans for promising medicines, providing a pathway for accelerated evaluation by the agency.
Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development, said: “Preliminary data on RG6042 were the first to show that levels of toxic mutant huntingtin protein can be lowered in adults with Huntington’s disease, and we are working closely with the EMA and other health authorities to initiate a global phase III study as soon as possible.”
Roche will now initiate a pivotal phase III study to evaluate RG6042 in a larger patient population to further characterise the safety profile and determine if it can slow the progression of HD in adults.