Recludix Pharma Announces Development Candidate Nomination of First-in-Class Oral STAT6 Inhibitor for Inflammatory Diseases and Achievement of Significant Milestone Under Collaboration with Sanofi

--Completion of GLP toxicology studies associated with a $50 million payment to Recludix under the collaboration with Sanofi

-- REX-8756 is a potent and selective oral STAT6 inhibitor that demonstrates complete pathway inhibition and is well tolerated in preclinical studies

--Investigational New Drug (IND)-enabling activities ongoing to support IND submission later this year

SAN DIEGO, June 02, 2025 (GLOBE NEWSWIRE) -- Recludix Pharma, a leader in the discovery of inhibitors of challenging targets for inflammatory disease, today announced that the company has nominated a lead development candidate REX-8756, an oral, selective and reversible small molecule inhibitor of STAT6, and completed the GLP toxicology studies for the compound. Many allergic and inflammatory diseases -- such as asthma, COPD, and atopic dermatitis -- are caused by Type 2 inflammation, driven by the production of the cytokines Interleukin-4 (IL-4) and Interleukin-13 (IL-13). 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 potential for fewer side effects.

“There is significant opportunity to develop oral medicines with biologic-like activity and favorable safety profiles to provide alternatives to current therapies, such as JAK inhibitors which can impact viral immunity and hematopoiesis,” said Nancy Whiting, Pharm.D., president and chief executive officer of Recludix. “At Recludix, we are driven to discover and develop best-in-class drug candidates that have the potential to become transformative medicines. We and our partner Sanofi are pleased to have reached this significant milestone in this important program and look forward to advancing REX-8756 to the clinic in the near term.”

In preclinical studies, REX-8756 achieved complete and durable STAT6 inhibition, without degradation of the protein. STAT6 inhibition disrupted the production of IL-4/13 stimulated inflammatory biomarkers and has demonstrated potent efficacy in models of asthma, acute lung inflammation and dermatitis. REX-8756 inhibits STAT6 through its SH2 domain, which plays a key role in mediating protein-protein interactions and had been previously deemed undruggable. Through Recludix’s proprietary platform that integrates new chemical approaches and technologies, the company has created massive custom SH2 domain-focused DNA-encoded libraries and proprietary selection assays, enabling the development of precision small molecule medicines against the SH2 domain of high-interest targets.

“We have discovered a number of oral STAT6 SH2 domain inhibitors that performed impressively in preclinical studies, speaking to the power of our platform,” said Ajay Nirula, M.D., Ph.D., executive vice president and head of research and development of Recludix. “Following our recently presented preclinical data at the May 2025 American Thoracic Society Conference that further demonstrated the robust efficacy and differentiated safety profile of our STAT6 inhibitors, we are excited to advance REX-8756 as a potential first-in-class oral therapy for patients with immune-related inflammatory disease.”

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 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 $125 million in near-term 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 leader in developing platform approaches to discover 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’s most advanced program is focused on STAT6 (signal transducer and activator of transcription 6) where abnormal activation is found in inflammatory diseases, such as atopic dermatitis, asthma, rheumatoid arthritis and chronic spontaneous urticaria. The company has a strategic collaboration with Sanofi for the development and commercialization of a STAT6 inhibitor. 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 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

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