TLC BioSciences Completes Phase 2 PK Trial for TLC599 in Japan

Paving way for upcoming US-Japan MRCT Phase 3 trial TLC BioSciences Corp. (TPEx: 7924, "TLC"), a clinical-stage biopharmaceutical company dedicated to the development of novel lipid nanoparticle therapies, today confirmed the completion of the last patient last visit (LPLV) in its Japanese pharmacokinetics (PK) clinical trial for TLC599. TLC599 is the company's proprietary, non-opioid long-acting injectable candidate designed for the treatment of osteoarthritis (OA) of the knee. The completion of this study marks a critical regulatory milestone, providing essential local human PK and safety data required by Japan's Pharmaceuticals and Medical Devices Agency (PMDA). This achievement directly supports TLC's global expansion strategy, establishing the groundwork for an upcoming joint US-Japan Multi-Regional Clinical Trial (MRCT) Phase 3 program and reinforcing ongoing commercialization efforts in Japan. The Japanese medical community places significant emphasis on long-term safety profiles and disease-modifying capabilities in knee osteoarthritis management. Designed to deliver sustained pain relief for up to six months via a single intra-articular injection, TLC599 addresses a primary gap in current standards of care by reducing the burden of frequent hospital visits and improving long-term treatment adherence. Furthermore, existing clinical data demonstrates that patients treated with TLC599 experienced lower rates of cartilage loss compared to the placebo group, highlighting its unique potential to preserve joint structure—a key competitive differentiator in the global OA market. Japan represents one of the world's fastest-aging demographics, resulting in a substantial medical burden from degenerative joint diseases. According to large-scale epidemiological data from the ROAD study and the Japanese Orthopaedic Association, approximately 25 million individuals aged 40 and older in Japan present with radiographic knee osteoarthritis, with over 8 million experiencing symptomatic pain. Full trial data analysis from the Japanese PK study is expected to be finalized and announced in the fourth quarter of 2026, which will further support commercialization efforts and regulatory filings. Following the successful completion of the Japanese PK trial, TLC is finalizing preparations for a joint US-Japan Phase 3 MRCT. This dual-region study will concurrently fulfill registration requirements for both major jurisdictions, streamlining TLC599's pathway toward market authorization and commercial entry. "Japan maintains rigorous standards for long-term clinical safety and patient quality of life," says George Yeh, Chief Executive Officer of TLC. "Completing our first clinical trial in Japan and acquiring localized PK and safety profile data represents a vital step forward in our global registration program. TLC599's potential for sustained pain control and cartilage protection directly responds to the unfulfilled needs of both Japanese clinicians and patients. As we advance our joint US-Japan Phase 3 trial, TLC remains focused on executing our long-acting product strategy to deliver sustainable value to patients, healthcare providers, and our shareholders."

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