The SUNFISH trial, an international phase II study of the splice-modifying drug RO7034067 in people with type 2 or 3 spinal muscular atrophy (SMA), begins in France at I-Motion.
The first French investigative centre of the SUNFISH trial has just opened: I-Motion is a paediatric clinical trial platform for neuromuscular diseases at the Institute of Myology, located at the Trousseau Hospital (Paris).
The SUNFISH trial is an international trial conducted by Hoffmann-La Roche. The aim of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RO7034067 (or RG7916) in 186 patients, aged 2 to 25 years, with type 2 or Type 3 SMA. RO7034067 corrects splicing of SMN2 to produce the missing SMN protein in SMA.
This trial has been divided into 2 successive parts: over an initial period of a few months, Part 1 aims to find a safe and tolerable dose, which will then be tested in Part 2 over 24 months. The trial will gradually be conducted in additional French clinical trial sites.
Note that another international trial of RO7034067 started in Belgium and Italy in December 2016: the FIREFISH trial includes 48 infants, aged 1 to 7 months, with type 1 SMA. This trial will also be conducted in French clinical trial sites, subject to regulatory authorisations.
> See on Clinicaltrials.gov: SUNFISH trial, FIREFISH trial
