Recludix Pharma Announces FDA Clearance of Investigational New Drug Application for REX-8756, an Oral STAT6 Inhibitor, to Enter into the Clinic

• REX-8756 is a potent and selective oral STAT6 inhibitor that has shown complete 100% pathway inhibition and potent efficacy in preclinical models of asthma, acute lung inflammation and dermatitis
• Efficacy comparable to anti-IL-4/IL-13 antibody combination control with a favorable tolerability profile in preclinical models
• Being advanced under a strategic partnership with Sanofi, where Recludix has the option to participate in a 50:50 U.S. profit/loss share

SAN DIEGO, Dec. 16, 2025 (GLOBE NEWSWIRE) — Recludix Pharma, a leader in the discovery of inhibitors of challenging targets for inflammatory disease, today 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.

“With REX-8756, we are excited by the opportunity to pioneer a new therapeutic class for patients with inflammatory diseases,” said Nancy Whiting, Pharm.D., president and chief executive officer of Recludix. “We have demonstrated preclinically that our reversible, orally available STAT6 inhibitor can achieve efficacy comparable to that of clinically validated biologics. By targeting the pathological overactivation of STAT6 observed in many diseases — without necessitating protein degradation and with an anticipated improved hematologic safety profile relative to JAK inhibitors — we believe this approach could be an important therapeutic option for patients. We look forward to initiating a Phase 1 clinical study of REX-8756 in healthy volunteers very shortly.”

REX-8756 is an oral, selective STAT6 inhibitor that employs a novel therapeutic approach by targeting STAT6’s SH2 domain — a key mediator of protein-protein interactions that was long considered undruggable. In preclinical studies, REX-8756 demonstrated complete and sustained inhibition of STAT6 activity, thereby suppressing IL-4 and IL-13-induced inflammatory biomarkers. STAT6 is required for IL-4 and IL-13 signaling but is downstream in the disease pathway from other drug targets, and therefore, its inhibition has been shown in preclinical studies to be a more selective approach than Janus Kinase (JAK) family inhibitors, with the potential for fewer side effects. 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.

About STAT6
Signal transducer and activator of transcription (STAT) proteins are both signaling proteins and transcription factors that play a role in cell growth, differentiation and function. STAT6 is a key nodal transcription factor that selectively mediates downstream signaling of IL-4 and IL-13, dominant and central cytokines in the pathophysiology of Type 2 inflammatory diseases. A STAT6 inhibitor offers the potential for a novel first-in-class targeted oral therapy for patients in the treatment of Type 2 inflammatory diseases.

About Recludix
Recludix is a company with leading, innovative platform approaches to discover and develop potent and selective inhibitors of challenging protein targets. The company’s management team includes industry veterans with a track record of success, including former leaders of Seagen, Blueprint Medicines, and Lilly. Recludix has developed a unique drug discovery platform that integrates custom generated DNA-encoded libraries, massively parallel determination of structure activity relationships, and a proprietary screening tool to ensure selectivity. The company is employing this approach first in the development of SH2 domain inhibitors.

Recludix is initiating a Phase 1 study of REX-8756 (also known as SAR448755), an oral inhibitor of STAT6, in a strategic development and commercialization partnership with Sanofi where Recludix has the option to participate in an equal U.S. profit/loss share. Abnormal activation of STAT6 is found in inflammatory diseases, such as atopic dermatitis, asthma, rheumatoid arthritis and chronic spontaneous urticaria.

Recludix is also advancing a potential first-in-class BTK SH2 domain inhibitor for B cell or mast cell-driven I&I diseases, as well as additional discovery programs. Recludix was named a 2024 Fierce 15 biotech company. For more information, please visit the company’s website at https://recludixpharma.com.

Recludix Contacts
Matt Caldemeyer
Chief Business Officer
mcaldemeyer@recludix.com

Alexandra Santos 
asantos@wheelhouselsa.com

Aljanae Reynolds
areynolds@wheelhouselsa.com