Recludix Pharma Receives FDA Clearance for Investigational New Drug Application for REX-8756, an Oral STAT6 Inhibitor, to Begin Clinical Trials

Recludix Pharma, a biotechnology company focused on discovering inhibitors for difficult-to-target pathways involved in inflammatory diseases, announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for REX-8756. This clearance allows the Company to begin Phase 1 clinical testing of REX-8756, an orally administered inhibitor of STAT6. The Company stated that REX-8756 represents a new therapeutic approach for the treatment of inflammatory diseases. 

Preclinical studies have shown that this reversible, oral STAT6 inhibitor can achieve levels of efficacy similar to those seen with established biologic therapies. By directly targeting the abnormal overactivation of STAT6 that is observed in a range of inflammatory conditions, REX-8756 is designed to intervene in disease pathways without requiring protein degradation. The Company also believes this mechanism may offer a more favorable hematologic safety profile compared with currently available Janus kinase inhibitors. Recludix plans to begin a Phase 1 clinical study of REX-8756 in healthy volunteers in the near term.

REX-8756 is a selective STAT6 inhibitor that targets the SH2 domain of the STAT6 protein, a region that plays a critical role in protein–protein interactions and was previously considered difficult to drug. In preclinical testing, the compound demonstrated complete and sustained inhibition of STAT6 activity, leading to suppression of inflammatory biomarkers induced by interleukin-4 and interleukin-13. STAT6 functions downstream in the IL-4 and IL-13 signaling pathway, which may allow for a more targeted and selective intervention compared with broader-acting therapies such as JAK inhibitors.

In multiple preclinical disease models, including asthma, acute lung inflammation, and dermatitis, REX-8756 showed strong anti-inflammatory effects. Its efficacy in these studies was comparable to that observed with a combination of antibodies targeting IL-4 and IL-13. Based on these results, Recludix believes REX-8756 has the potential to become an important new oral treatment option for patients with inflammatory diseases and is advancing the program into clinical development.