--Phase 1 study of REX-8756 is well underway following FDA clearance of the Investigational New Drug (IND) application in December 2025
--In preclinical studies, REX-8756 elicited complete, rapid and durable inhibition of STAT6, resulting in potent, biologic-like activity without protein degradation in models of inflammatory diseases
--Several healthy volunteers have already received REX-8756, triggering a milestone payment of $20 million to Recludix under the collaboration with Sanofi
SAN DIEGO, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Recludix Pharma, a clinical-stage company leading the discovery and development of inhibitors of challenging targets for inflammatory disease, today announced it has begun dosing healthy volunteers in a Phase 1 study of REX-8756 (also known as SAR448755), an oral, small molecule STAT6 inhibitor that has demonstrated compelling efficacy and safety in preclinical models of different types of inflammatory diseases based on selective and complete STAT6 inhibition. The achievement of this milestone triggered a payment of $20 million to Recludix under the collaboration agreement with Sanofi.
“The initiation of our first clinical study is a pivotal step forward in executing our long-term vision of discovering and developing innovative medicines for patients in need. This milestone reflects the strength of our science and platform, as well as the capabilities of our highly experienced team,” said Nancy Whiting, Pharm.D., president and chief executive officer of Recludix. “We see tremendous potential for our STAT6 inhibitor, REX-8756, to set a new standard in the treatment of Type 2 inflammatory diseases.”
“We are excited to advance REX-8756 to the clinic, especially given the robust efficacy and differentiated safety profile it demonstrated in preclinical studies. We would like to acknowledge our partner Sanofi for their valuable contributions and collaboration in accelerating this progress. Both companies share the excitement of reaching this important milestone together and look forward to generating the clinical data that will guide our next phase of development,” said Ajay Nirula, M.D., Ph.D., executive vice president and head of R&D at Recludix.
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. The study includes single ascending dose (SAD) and multiple ascending dose (MAD) cohorts.
About Sanofi Collaboration
Recludix is advancing STAT6 inhibitors from preclinical research and development until the start of Phase 2 clinical trials. Sanofi will assume worldwide clinical development and commercialization responsibilities thereafter. Sanofi has global rights to small molecule STAT6 inhibitors developed under the partnership. Recludix has the option to participate in a 50% U.S. profit/loss share, which includes the ability to share equally in the costs, profits and losses, and to certain co-promotion activities for the partnered product in the U.S. Recludix has now received $145 million in milestone payments. Additionally, Recludix may receive more than $1.2 billion in potential development, regulatory and sales milestones, as well as up to double-digit royalties on possible future product sales.
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 clinical-stage 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 conducting 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, chronic obstructive pulmonary disease 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
