Tightly Spring Now., page-35

Hi Pigreco

Obviously, sarizotan is a step ahead of trofinetide on the development pathway to regulatory approval. Newron is due to report its Phase 3 trial results this quarter, whereas the Phase 3 trofinetide trial only starts this quarter. Newron’s Phase 2/3 trial, by the way, has taken 3 years.

If Newron’s trial results are successful, and if the FDA approves sarizotan, it will become the first drug approved for treatment within the Rett syndrome population. However, if approved, sarizotan will be indicated for the treatment of the breathing irregularities which are a common symptom of Rett syndrome, whereas trofinetide is intended to treat multiple symptoms found across the broader Rett population.