Roche provides community statement regarding SUNFISH, a clinical trial of RG7916 for SMA Types 2/3.
An interim analysis was recently presented at the International Conference of the World Muscle Society in France. In this analysis, all participants (51 people) had received RG7916 for 28 days or longer. SMN protein increased by up to two and a half times. This increase has been sustained throughout the duration of treatment (up to 250 days). To date, RG7916 remains well-tolerated at all doses and no-one has withdrawn from any RG7916 study due to drug related side effects.
The information from Part 1 has allowed Roche to confirm the dose of RG7916 for Part 2 of SUNFISH
and the first patient has been enrolled into Part 2.