REX-8756 / Recludix Pharma, Sanofi - LARVOL DELTA

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