Commercial stage biotechnology company Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) announced on Monday that it has received Fast Track designation from the US Food and Drug Administration (FDA) for R289 for the treatment of patients with previously treated transfusion dependent lower-risk myelodysplastic syndrome (LR-MDS).

R289 is the company's potent and selective dual inhibitor of IRAK1 and IRAK4 and is being studied in an ongoing Phase 1b study assessing the safety, tolerability, pharmacokinetics and preliminary activity in patients with LR-MDS who are relapsed or refractory to prior therapies. It is a prodrug of R835, which has been shown in preclinical studies to block inflammatory cytokine production in response to toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) family signalling.

Raul Rodriguez, Rigel's president and CEO, said: "We are pleased that R289 has been granted Fast Track designation, which underscores the significant unmet need for patients with transfusion dependent lower-risk MDS. By targeting inflammatory signalling, we believe that R289 has the potential to meaningfully improve the lives of those living with this disease."