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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

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--Phase 1 study of REX-8756 is well underway following FDA clearance of the Investigational New Drug...

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REX-8756 Phase 1 study underway, showing potential for inflammatory disease treatment. Sanofi made a $20 million milestone payment to Recludix for the collaboration. The partnership allows Sanofi to lead global development of small molecule STAT6 inhibitors. Recludix could earn an estimated $1.2 billion in future milestones and royalties. STAT6 inhibitors may offer new targeted therapies for Type 2 inflammatory diseases.

Sentiment Rationale

The collaboration's potential and milestone payments indicate a positive outlook for SNY's stock performance.

Trading Thesis

As REX-8756 progresses, successful trials could establish long-term revenue streams for Sanofi.

Market-Moving

  • REX-8756 Phase 1 study underway, showing potential for inflammatory disease treatment.
  • Sanofi made a $20 million milestone payment to Recludix for the collaboration.
  • The partnership allows Sanofi to lead global development of small molecule STAT6 inhibitors.

Key Facts

  • REX-8756 Phase 1 study underway, showing potential for inflammatory disease treatment.
  • Sanofi made a $20 million milestone payment to Recludix for the collaboration.
  • The partnership allows Sanofi to lead global development of small molecule STAT6 inhibitors.
  • Recludix could earn an estimated $1.2 billion in future milestones and royalties.
  • STAT6 inhibitors may offer new targeted therapies for Type 2 inflammatory diseases.

Companies Mentioned

  • SNY (SNY)
  • AMGN (AMGN)
  • ABBV (ABBV)
  • PFE (PFE)

Corporate Developments

Key partnerships and potential new product lines could significantly enhance Sanofi's market position.

Recludix Pharma Initiates Phase 1 Study for REX-8756, Receives $20 Million Milestone Payment from Sanofi

On January 12, 2026, Recludix Pharma, Inc. announced the dosing of the first volunteers in a Phase 1 clinical trial for REX-8756, also known as SAR448755, a selective oral STAT6 inhibitor. This announcement follows FDA approval of the Investigational New Drug (IND) application in December 2025. The initiation of this clinical study has triggered a significant milestone payment of $20 million from Sanofi (SNY), marking an important advancement in their ongoing collaboration.

Details of the Phase 1 Study

The Phase 1 trial of REX-8756 aims to evaluate the compound's safety, tolerability, pharmacokinetics, and pharmacodynamics. Approximately 100 healthy volunteers will participate in this blinded, placebo-controlled study, which includes both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Preclinical studies have indicated that REX-8756 exhibits robust efficacy and safety profiles, achieving complete and durable inhibition of STAT6 in models of inflammatory diseases.

Insights from Recludix Leadership

Nancy Whiting, Pharm.D. and CEO of Recludix, emphasized the significance of this milestone, stating, “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.” Whiting expressed optimism about the potential of REX-8756 to establish a new standard in treating Type 2 inflammatory diseases.

Ajay Nirula, M.D., Ph.D., the Executive Vice President and Head of R&D, further commented, “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 share in the excitement with our partner Sanofi and look forward to generating clinical data that will guide our next phase of development.”

Collaboration with Sanofi

The partnership with Sanofi is integral to the advancement of REX-8756, where Sanofi will oversee worldwide clinical development and commercialization after the Phase 2 trials. Under this collaboration, Recludix holds an option to participate in a 50% U.S. profit and loss share. To date, Recludix has received $145 million in milestone payments from Sanofi, with potential additional revenues exceeding $1.2 billion in development, regulatory, and sales milestones, along with possible double-digit royalties on future product sales.

Understanding STAT6 Inhibition

STAT6, or signal transducer and activator of transcription-6, plays a crucial role in mediating the effects of the prominent cytokines IL-4 and IL-13, which are significantly involved in the pathogenesis of Type 2 inflammatory diseases. REX-8756’s targeted approach to inhibit STAT6 represents a potential breakthrough in therapy for conditions like asthma, chronic obstructive pulmonary disease, and atopic dermatitis.

About Recludix Pharma

Recludix Pharma is a clinical-stage biotechnology company focused on developing inhibitors for challenging therapeutic targets. Harnessing a unique drug discovery platform, the company aims to deliver innovative solutions in the treatment of inflammatory diseases. With a seasoned management team previously affiliated with organizations like Seagen and Blueprint Medicines, Recludix is positioned at the forefront of therapeutic innovation and was recognized as a 2024 Fierce 15 biotech company.

Contact Information

For further inquiries, please contact:

  • Matt Caldemeyer, Chief Business Officer - mcaldemeyer@recludix.com
  • Alexandra Santos - asantos@wheelhouselsa.com
  • Aljanae Reynolds - areynolds@wheelhouselsa.com

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