REX-8756 / Recludix Pharma, Sanofi - LARVOL DELTA

REX-8756 is an oral first-in-class orthosteric STAT6 inhibitor that demonstrates efficacious potential in TH2-mediated asthma models (ERS 2026) - "These findings collectively support the rationale that inhibiting STAT6 activation can mitigate Th2 mediated lung inflammation, demonstrating the therapeutic potential of REX-8756 in eosinophilic diseases. REX-8756 brings the promise of combining the efficacy of clinically validated biologics with the convenience of oral administration."

Asthma • Eosinophilia • Hematological Disorders • Immunology • Inflammation • Pneumonia • Respiratory Diseases • IL13 • IL4 • IL5

Recludix Pharma to Present Preclinical Asthma and Dermatitis Data for Oral STAT6 Inhibitor REX-8756 at the European Association of Allergy and Clinical Immunology (EAACI) and Revolutionizing Atopic Dermatitis (RAD) Congresses (GlobeNewswire) - "The preclinical data demonstrate that REX-8756 is well tolerated, achieves complete inhibition of phosphorylation-mediated STAT6 (pSTAT6) activation, and results in efficacy comparable to antibody-mediated blockade of anti-IL-4/13 pathways across disease models. Additionally, pSTAT6 inhibition is rapidly reversible within days of dosing cessation, demonstrating that orthosteric inhibition of the STAT6 SH2 domain results in both durable and reversible inhibition without degradation."

Preclinical • Asthma • Atopic Dermatitis

REX-8756 is a First-in-Class Potent and Selective Orthosteric STAT6 Inhibitor That Demonstrates Efficacious Potential and Safety Differentiation in TH2-Mediated Inflammation (EAACI 2026) - "Conclusion In preclinical studies, once daily dosing of REX-8756 is well tolerated, achieves complete inhibition of phosphorylation-mediated STAT6 activation translating to efficacy comparable to antibody-mediated blockade of anti-IL-4/13 pathways in both allergic asthma and dermatitis in vivo models. Preclinical in vivo efficacy is associated with a dose-dependent reduction of pSTAT6 across multiple tissue types as well as Th2 cytokines (IL-13, IL-5) within the immune compartment."

Clinical • Dermatitis • Immunology • Inflammation • IL13 • IL4 • IL5

REX-8756 is an oral first-in-class orthosteric STAT6 inhibitor that demonstrates efficacious potential and safety differentiation in a TH2-mediated dermatitis model (SID 2026) - "Preclinical efficacy was also associated with reductions of Th2 cytokines (IL-13, IL-5) within the immune compartment. Selective, reversible STAT6 inhibition brings the promise of combining the efficacy of clinically validated biologics with the convenience of oral administration, while potentially avoiding JAK inhibitor safety concerns."

Clinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • IL13 • IL4 • IL5

Recludix Pharma…presented preclinical data for REX-8756 demonstrating its potent preclinical efficacy and differentiated safety profile in a model of atopic dermatitis at the Society for Investigative Dermatology (SID) Annual Meeting (GlobeNewswire) - "In a Th2-mediated model of atopic dermatitis, blocking STAT6 activation with REX-8756 administered orally to mice attenuated skin inflammation with efficacy comparable to monoclonal antibodies targeting IL-4/IL-13 signaling pathways. Preclinical efficacy was also associated with reductions of Th2 cytokines (IL-13, IL-5) within the immune compartment."

Preclinical • Atopic Dermatitis

Recludix Pharma Announces Dosing of First Subjects in a Phase 1 Study of REX-8756, a Potent and Selective Oral STAT6 Inhibitor, and Achieves Associated $20 Million Milestone Payment Under Collaboration with Sanofi (GlobeNewswire) - "The blinded, placebo-controlled Phase 1 study is expected to enroll approximately 100 healthy volunteers across multiple cohorts to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of orally administered REX-8756."

Financing • Trial status • Immunology • Inflammation

Recludix Pharma…announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application to advance REX-8756, an oral STAT6 inhibitor, into Phase 1 clinical testing (GlobeNewswire) - "'We look forward to initiating a Phase 1 clinical study of REX-8756 in healthy volunteers very shortly'....REX-8756 has demonstrated potent efficacy in models of asthma, acute lung inflammation and dermatitis, comparable to that of an anti-IL-4/IL-13 antibody combination control."

IND • New P1 trial • Asthma • Dermatology • Inflammation • Respiratory Diseases

Recludix Pharma Advances First-in-Class Oral STAT6 Inhibitor REX-8756 for Inflammatory Diseases, Including Atopic Dermatitis (DermatologyTimes) - "The announcement coincides with the completion of Good Laboratory Practice (GLP) toxicology studies for the candidate, a milestone that initiated a $50 million payment under the company’s collaboration with Sanofi...Recludix reports that REX-8756 exhibits complete STAT6 pathway inhibition in vitro and in vivo, durable target engagement without requiring continuous high plasma exposure, potent suppression of IL-4/IL-13-induced biomarkers, and efficacy in murine models of asthma, acute lung inflammation, and dermatitis...With Investigational New Drug (IND)-enabling studies underway, Recludix plans to submit an IND application later in 2025."

IND • Preclinical • Asthma • Dermatitis • Immunology • Inflammation