Sitryx nominates SIT-047, a novel, oral MTHFD2 inhibitor, for clinical development in psoriatic arthritis

Business Upturn

06-05-2025

By GlobeNewswire Published on May 6, 2025, 16:00 IST Novel, oral candidate with first-in-class potential progresses to regulatory non-clinical studies to support a Clinical Trial Authorisation
First indication will be psoriatic arthritis, a multi-billion dollar market opportunity, with potential across multiple autoimmune conditions, based on strong translational data package
Regulatory submission preparation and entry into the clinic is expected in H1 2026
Oxford, UK – 6 May 2025 – Sitryx Therapeutics ('the Company'), a clinical-stage biopharmaceutical company developing novel oral therapies to restore immune balance in autoimmune and inflammatory disease, today announces the nomination of SIT-047, a novel, oral MTHFD2 inhibitor, as the latest development candidate from its proprietary pipeline to progress to regulatory non-clinical studies to support a Clinical Trial Authorisation (CTA).
Psoriatic arthritis is a chronic and debilitating autoimmune disease that causes joint inflammation, affecting over a million people in the US alone and 30% of patients with the chronic skin condition, psoriasis, representing a multi-billion dollar market opportunity. Despite existing therapies, a large number of patients remain underserved, with a clear unmet need for safe and effective oral therapies targeting both skin and joint symptoms. SIT-047 offers first-in-class potential as a disease-modifying treatment for psoriatic arthritis. By targeting MTHFD2, a key enzyme in one-carbon metabolism, SIT-047 is designed to regulate the activity of Th1 and Th17, immune cell subsets known to drive disease pathology in psoriatic arthritis.
SIT-047 has demonstrated strong efficacy in preclinical models and represents a promising precision immunometabolic approach to immune modulation. Sitryx's preclinical data package supports its progression into regulatory studies, with compelling efficacy in disease models and favourable tolerability. In addition to psoriatic arthritis, SIT-047 also holds potential across a range of autoimmune conditions where MTHFD2 is strongly upregulated, including rheumatoid arthritis, lupus, Crohn's disease, ulcerative colitis, and atopic dermatitis.
Iain Kilty, Chief Executive Officer of Sitryx, commented: 'The nomination of SIT-047 for clinical development in psoriatic arthritis is further evidence of the breadth and depth of our pipeline and this company's continued progress translating our deep expertise in immunometabolism into meaningful therapeutic candidates. With compelling data and a strong mechanistic rationale, we look forward to advancing SIT-047 toward clinical development and continuing to unlock the potential of immunometabolism to transform patient care.'
Ravi Rao, Chief Medical Officer of Sitryx, commented: 'Psoriatic arthritis remains a challenging condition to manage, with many patients failing to achieve sustained control of both joint and skin symptoms. SIT-047 offers a promising new approach with the potential to address this unmet need through a differentiated mechanism that targets key disease-driving immune cells. We are excited about its clinical potential and the broader opportunities for MTHFD2 inhibitors across other autoimmune diseases.'
Regulatory submission preparation and entry into the clinic is expected in H1 2026. SIT-047 will be the third program to enter clinical development from Sitryx's portfolio. In March 2025 Sitryx initiated a Phase 1 trial to evaluate SYX-5219, an oral pyruvate kinase M2 (PKM2) modulator, in atopic dermatitis. That followed the commencement in 2024 of a Phase 1 trial by Sitryx's partner, Eli Lilly and Company, to develop SYX-1042 (itaconate mimetic), a post-translational modification modulator program developed as part of a global licensing and research collaboration between the two companies.
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For more information about Sitryx please contact:
ICR HealthcareMary-Jane Elliott, David Daley, Sue Stuart+44 (0)20 3709 5700
[email protected]
About Sitryx
Sitryx is a clinical-stage biopharmaceutical company developing novel oral therapies to restore immune balance in autoimmune and inflammatory disease. The Company has a broad pipeline of novel small molecule candidates targeting major autoimmune indications with high unmet need. Its lead candidate, SYX-5219, is a potentially first-in-class PKM2 modulator in development for atopic dermatitis as a once-daily oral therapy with future development potential across multiple autoimmune diseases.
In 2020, Sitryx formed an exclusive global licensing and research collaboration with Eli Lilly and Company, with the first program, SYX-1042 (itaconate mimetic), now in-house at Eli Lilly and Company and in clinical development, with the commencement of a Phase 1 trial in January 2024.
Established in 2018 with seed funding from SV Health Investors, Sitryx has raised $85 million to date from an international syndicate of specialist investors including SV Health Investors, Sofinnova Partners, Oxford Science Enterprises, Longwood Fund, Eli Lilly and Company, and GSK.
Sitryx is headquartered in Oxford, UK. For more information, please visit www.sitryx.com.
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