Syros Pharmaceuticals announces today that it was given an orphan drug designation by the US FDA to tamibarotene for the treatment of myelodysplastic syndrome. The company is pleased about the new grant and aims to achieve the best results afterward, said Steven R. Goodman, President and Chief Executive Officer of Syros Pharmaceuticals. They believe that the designation will provide further incentive for development partners to pursue development and commercialization opportunities related to tamibarotene in this indication.
They do not currently have a manufacturing facility for the product candidates. The company currently relies on third-party manufacturers to produce clinical and commercial quantities of plazomicin, including any potential future approved products, subject to agreements that they expect will require them to manufacture these products at their facilities under our specifications and control.
The company intends to continue outsourcing the manufacturing of plazomicin. The Phase 2 trial is designed to evaluate the safety and efficacy of the combination by measuring overall response rate (ORR), duration of response (DOR), and progression-free survival.