News that Roche has made the difficult decision to end the development of neuro-protective compound Olesoxime, was announced on 30th May.
The OLEOS study, evaluating the safety and effectiveness of Olesoxime, was started in 2016. Since then, ongoing discussions with Health Authorities (FDA and EMA) and SMA experts were held and the company has continued to work to improve dosage, the formulation of Olesoxime and to design the best Phase 3 study to be able to show the efficacy of the treatment.
Furthermore, they regularly analysed the data from this study. Whilst the data at 12 months of treatment with olesoxime were initially encouraging, the most recent analysis at 18 months, which was presented at the American Academy of Neurology in April 2018, actually showed a worsening in motor function.
Unfortunately, despite all of efforts and a strong will to deliver olesoxime as a medicine for those living with SMA, Roche has concluded that this is not going to be possible. Based on all of the available evidence and the continued difficulties described above, the company has decided to stop further development of the treatment.
Many of you will understandably be disappointed by the news, as we are. Roche’s current priority is to ensure those still taking part in the ongoing OLEOS study understand what this decision means for them and that they are provided with appropriate treatment options. Roche is working closely with study sites and investigators to help identify options for those still taking part in the OLEOS study and will share more details in the coming weeks. The OLEOS study will be kept open until all ongoing participants have an alternative treatment option confirmed.