Global First-in-Class AT2R Antagonist TRD205 Advances to Phase II: First Patient Dosed in Chronic Post-Surgical Neuropathic Pain Trial

BEIJING, May 5, 2025 /PRNewswire/ -- Beijing Tide Pharmaceutical Co., Ltd., a subsidiary of Sino Biopharmaceutical Limited (1177.HK), has achieved a milestone in developing its first-in-class analgesic drug (research code: TRD205), a highly selective angiotensin II type 2 receptor (AT2R) antagonist, with the first patient successfully dosed. As the first globally innovative drug targeting chronic post-surgical neuropathic pain (CPSP) to enter Phase II clinical development, TRD205 is positioned to overcome the limitations of existing opioid therapies and provide a safer, more effective solution for hundreds of millions of patients worldwide.

Mechanistic Breakthrough: Pioneering Non-Opioid Analgesic Pathways via AT2R Targeting

CPSP affects approximately 10% of surgical patients globally, translating to over 30 million cases annually. Current treatments face significant constraints: opioids demonstrate efficacy in only 25% of patients while carrying risks of addiction and depression, whereas NSAIDs and antidepressants show limited efficacy against neuropathic pain. TRD205's core innovation lies in its precise inhibition of AT2R, a receptor whose abnormal activation post-peripheral nerve injury triggers macrophages to release reactive oxygen/nitrogen species. This process exacerbates calcium influx in dorsal root ganglion (DRG) sensory neurons, amplifying pain sensitization. By selectively blocking this pathway, TRD205 suppresses pain signaling at its source without engaging the central nervous system, thereby avoiding opioid-related risks such as addiction and respiratory depression. The drug has secured clinical trial approvals from both the U.S. FDA and China's NMPA, with Phase I trials in healthy Chinese volunteers confirming favorable safety and pharmacokinetic profiles.

Addressing the Urgent Unmet Need in CPSP: A Public Health Priority

CPSP defined as pain persisting for over three months following surgery, impacts approximately 10% of the 320 million annual surgical patients globally. It is particularly prevalent after procedures such as limb amputation (50%-85%), thoracotomy (30%-50%), breast surgery (25%-50%), and hernia repair (5%-35%), etc. Beyond physical suffering, CPSP is closely linked to anxiety, depression, and other symptoms. Existing therapies address less than 30% of clinical demand, highlighting the critical need for novel mechanisms like TRD205's opioid-free approach. The Phase II study plans to enroll 184 patients with CPSP to evaluate pain score (NRS) improvements across dose groups over a six-week period.

Market Potential and Strategic Positioning in a $10 Billion Landscape

Global AT2R-targeted drug development remains nascent, with only a few competitors like Lilly-partnered CFTX-1554 (Phase I). TRD205's approval would make it the first AT2R therapy for CPSP, with expansion potential into indications such as diabetic neuropathy and postherpetic neuralgia—a combined market exceeding $10 billion.

TRD205's Phase II trial initiation marks a pivotal transition from opioid-dependent analgesia to precision targeting. Successful clinical validation would deliver a novel therapeutic paradigm for over hundreds of millions of patients globally.

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SOURCE Beijing Tide Pharmaceutical Co., Ltd.