Recludix Pharma, a 2024 Fierce 15 biotech company and a renowned leader in the discovery of inhibitors for challenging protein targets, has made a groundbreaking announcement. The company has nominated REX-8756, a first-in-class oral STAT6 inhibitor, as a lead development candidate in the fight against inflammatory diseases such as asthma, atopic dermatitis, and rheumatoid arthritis. This nomination follows the successful completion of GLP toxicology studies, a significant milestone underpinned by a $50 million payment from Sanofi, Recludix’s strategic collaborator.
REX-8756, a selective and reversible small molecule inhibitor of STAT6, has demonstrated compelling preclinical results. The compound effectively inhibits STAT6, a key player in the signaling pathway of Interleukin-4 (IL-4) and Interleukin-13 (IL-13), two cytokines known to drive Type 2 inflammation. This inflammation is a common denominator in a multitude of allergic and inflammatory diseases, including chronic spontaneous urticaria.
What sets REX-8756 apart is its selectivity. Unlike Janus Kinase (JAK) family inhibitors, which have a broader reach and can impact viral immunity and hematopoiesis, REX-8756 zeroes in on the disease pathway’s downstream processes. This precision inhibition has shown potential for reduced side effects, rendering the compound a valuable alternative to current therapies.
“At Recludix, we are committed to discovering and developing best-in-class drug candidates with biologic-like activity and favorable safety profiles,” said Nancy Whiting, Pharm.D., president and chief executive officer of Recludix. “In collaboration with Sanofi, we are delighted to have reached this significant milestone and are excited to progress REX-8756 to the clinical stage.”
The potency of REX-8756 lies in its ability to disrupt the production of IL-4/13 stimulated inflammatory biomarkers, as evidenced by its efficacy in models of asthma, acute lung inflammation, and dermatitis. The compound inhibits STAT6 via its SH2 domain, a critical component in mediating protein-protein interactions previously deemed undruggable.
Recludix’s innovative drug discovery platform, which integrates custom DNA-encoded libraries and proprietary screening tools, has been instrumental in this breakthrough. The platform’s focus on developing SH2 domain inhibitors has enabled the creation of precision small molecule medicines against high-priority targets, setting a new paradigm in biotech for tackling challenging protein targets.
In addition to REX-8756, Recludix is steering a potential BTK SH2 domain inhibitor for B cell or mast cell-driven Immunity and Inflammation (I&I) diseases, further expanding the company’s portfolio.
As Recludix continues to advance its innovative pipeline, their work underscores the potential of targeted therapies to transform the treatment of inflammatory diseases, redefining the landscape of biotech innovation in the process. This nomination marks not just a milestone for Recludix, but a promising leap forward for the industry and the patients it serves.
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