META Pharmaceuticals Inc., a company incubated by XTALPI (02228), recently announced the designation of its first clinical development candidate molecule, MP-5342, for Inflammatory Bowel Disease (IBD). The company is now actively preparing an Investigational New Drug (IND) application, with formal clinical trial registration expected to commence as early as the second half of 2026. MP-5342 is the world's first oral small-molecule Lactate Dehydrogenase (LDH) inhibitor developed by META Pharma with enablement from XTALPI.

As a potential first-in-class (FIC) and best-in-class (BIC) drug candidate representing genuine novel innovation, MP-5342 precisely targets the underlying biological mechanisms of immunometabolism. It aims to remodel immune balance and alter disease progression through metabolic reprogramming, enabling safer and more efficient anti-inflammatory treatment. This candidate has the potential to fill a therapeutic gap for the LDH target. The pipeline not only addresses the multi-billion-dollar primary IBD treatment market but also possesses significant potential for rapid expansion into other high-incidence autoimmune indications, such as Multiple Sclerosis (MS) and Atopic Dermatitis, due to its broad-spectrum mechanism of action, potentially elevating its market opportunity to a trillion-dollar golden track.

MP-5342 is the second FIC pipeline developed through the collaboration between XTALPI and META Pharma to approach clinical development. This progress further validates the leading capabilities of XTALPI's AI and robotics-driven drug discovery platform in achieving breakthrough innovation, efficient clinical translation, and reproducible technology. Leveraging its unique platform advantages, XTALPI is broadly empowering the development of a new generation of innovative drugs, systematically and scalably creating high-value pipeline assets for partners and generating value for the industry.

Inflammatory Bowel Disease (IBD) is a chronic and debilitating condition for which there is currently no complete cure. Data indicates that the global IBD treatment market is projected to grow from $29.57 billion in 2024 to $44.08 billion by 2032, at a compound annual growth rate (CAGR) of 5.8%. However, existing therapies commonly face key challenges such as clinical remission rates below 40%, drug resistance, significant systemic side effects, and disease relapse, representing a substantial unmet medical need. The emerging therapeutic strategy of targeting LDH inhibition, by modulating a key enzyme in cellular glucose metabolism, can effectively regulate T-cell and B-cell function, potentially rebalancing a dysregulated immune system and restoring the function of abnormal immune cells, showing broad promise for various autoimmune diseases including IBD.

MP-5342 is an oral LDH inhibitor co-developed by XTALPI and META Pharma based on XTALPI's AI and robotics drug discovery platform. During the discovery process, META Pharma successfully identified and validated LDH as a key target based on the前沿 "immunometabolic checkpoint" theory. XTALPI utilized advanced Free Energy Perturbation (FEP) calculations to precisely assess the binding strength of candidate molecules to the target protein, rapidly identifying compound core structures with higher activity and superior drug-like properties. Concurrently, the high-throughput robotics experimental platform accelerated the synthesis, testing, and iterative optimization of compound molecules, providing META Pharma with multi-dimensional core technical support that facilitated the rapid confirmation of MP-5342 as the preclinical candidate compound (PCC) for IBD.

Preclinical data robustly demonstrates the advantages of MP-5342 as a potential FIC and BIC candidate. In preclinical animal disease models, MP-5342 exhibited a safety window exceeding 600-fold, far surpassing the industry's conventional safety threshold (typically >40-fold). Across six standard efficacy models for IBD induced by different mechanisms, MP-5342 demonstrated significant efficacy alongside higher safety and lower toxicity compared to existing standard therapies. In combination with novel biologic agents, MP-5342 has the potential to precisely address the shortcomings of current treatments, achieving rapid inflammation remission, accelerated mucosal healing, and significantly reduced relapse risk, offering more sustained disease control. Furthermore, its oral administration is expected to greatly enhance patient compliance and convenience, while lower production costs could reduce the long-term economic burden on patients and provide positive support for healthcare systems.

Based on its strategy of modulating immunometabolic pathways, MP-5342 shows strong potential for indication expansion, potentially rapidly covering various high-incidence autoimmune diseases caused by immune and metabolic system dysregulation, including Multiple Sclerosis (MS), Atopic Dermatitis, and Primary Biliary Cholangitis (PBC). Owing to its broad regulatory effect on this underlying pathological mechanism, MP-5342 has the opportunity to rival broad-spectrum therapies in the same field with annual sales reaching tens of billions of dollars, targeting the global trillion-dollar golden market for autoimmune diseases.

Previously, XTALPI and META Pharma collaborated on META-001-PH, a world-first small-molecule inhibitor for Primary Hyperoxaluria, which has received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) from the FDA. As a leading global AI and robotics drug R&D platform, the successive advancement of collaborative pipelines like MP-5342 and META-001-PH into clinical translation continuously validates XTALPI's ability to efficiently transform前沿 biological discoveries into pipeline assets with distinct competitive advantages. As more innovative drug pipelines discovered and optimized with XTALPI's involvement enter clinical stages, the company will continue to accumulate R&D data to drive iterative upgrades of its AI algorithms, empowering more partners to accelerate breakthrough innovations, promote faster global patient access to transformative therapies, and realize the immense social value and economic potential of artificial intelligence in the biopharmaceutical field.