Innovo Therapeutics Receives Phase 1 Clinical Trial Approval in Korea for Degenerative Joint Disease Treatment

Innovo Therapeutics’ inflammasome inhibitor drug candidate, INV-004, has received Phase 1 clinical trial approval from the Ministry of Food and Drug Safety (MFDS) in Korea.

According to Innovo Therapeutics on September 16, INV-004 is a novel drug candidate intended for intra-articular injection in patients with knee osteoarthritis, a type of degenerative joint disease. The newly approved clinical trial is a randomized, placebo-controlled, double-blind Phase 1 study. The primary objective is to assess the safety and tolerability of the drug for up to 12 weeks after administration, as well as to evaluate disease improvement indicators to determine the potential for disease modification.

INV-004 is designed to directly block intra-articular inflammatory responses by inhibiting the inflammasome pathway, which mediates both inflammation and inflammatory cell death. Unlike existing therapies such as non-steroidal anti-inflammatory drugs (NSAIDs), hyaluronic acid injections, or intra-articular steroid injections, which are limited to symptomatic relief, INV-004 targets the inflammatory signaling pathway. This approach has the potential not only to reduce pain, but also to suppress cartilage damage.

Previously, in October 2023, INV-004 was selected as a project supported by the National New Drug Development Project (R&D) led by the National New Drug Development Institute. Through the support of this project, Innovo Therapeutics conducted preclinical studies on the degenerative joint disease candidate INV-1498 and advanced research and development aimed at obtaining IND approval for Phase 1 clinical trials.

CEO Park Heedong stated, "Through this clinical trial, we plan to focus on verifying the initial safety, tolerability, and disease-modifying efficacy of INV-004."

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