Inventera Receives Phase 3 IND Approval for Musculoskeletal MRI Contrast Agent Candidate

Inventera, a company specializing in the development of new MRI contrast agents, announced on the 18th that it has received approval from the Ministry of Food and Drug Safety (MFDS) for the clinical phase 3 investigational new drug (IND) application for its musculoskeletal-targeted MRI contrast agent candidate, INV-002.

In February, Inventera successfully completed the domestic phase 2b clinical trial of INV-002. The phase 2b trial in Korea demonstrated excellent MRI contrast effects. The safety profile also showed outstanding results, with the trial concluding without any significant adverse effects.

This phase 3 IND approval has come just four months after the completion of the domestic phase 2b trial. This rapid approval reflects a high level of trust in the quality and safety of INV-002. By entering phase 3 clinical trials quickly and without any major issues related to quality (CMC), Inventera has shown strong confidence in obtaining marketing authorization for INV-002.

INV-002 (product name: NEMO-103 injection) is an MRI contrast agent candidate being developed for MR arthrography. The phase 3 clinical trial will target 85 patients with musculoskeletal diseases of the shoulder, including rotator cuff tears, labral tears, articular cartilage tears, and frozen shoulder. The trial will be conducted at eight major university hospitals, including the "Big 4." To expedite the clinical process, Inventera has already completed key procedures such as IRB approval, making an early start to the trial highly likely.

In March 2024, Inventera signed an exclusive domestic distribution agreement with Dongkook Lifescience, a leading Korean MRI contrast agent distributor, to enable rapid market entry in line with phase 3 clinical development. With the synergy between Dongkook Lifescience's sales and marketing capabilities and Inventera's technology, INV-002 is expected to become a new game changer in both domestic and international markets, where no new MRI contrast agent has been developed for a long time.

Inventera also plans to actively pursue exports to Asian markets, including China, Japan, and Southeast Asia, through Dongkook Lifescience. Dongkook Lifescience currently exports contrast agent active pharmaceutical ingredients to 25 countries, including China, Japan, and Southeast Asia, ensuring a robust distribution network. This is expected to facilitate the rapid expansion of Inventera's contrast agent export markets.

Inventera is a biotech company that succeeded in developing the world's first safe iron-based T1-MRI contrast agent. Based on its proprietary nanomolecule technology, the company has established an MRI contrast agent pipeline specialized for various conditions, including arthrography, lymphography, and pancreatobiliary imaging. The lymphography-specialized contrast agent INV-001 is currently in phase 2a clinical trials in Korea, and the pancreatobiliary-specialized contrast agent INV-003 is undergoing preclinical studies for clinical entry within this year. INV-002, which has now entered domestic phase 3 clinical trials, also received phase 2b IND approval from the U.S. Food and Drug Administration (FDA) in November last year, with U.S. clinical trials scheduled for this year.

Meanwhile, Inventera is preparing for an initial public offering (IPO) on the KOSDAQ market and is currently carrying out related procedures. The company recently passed the technical evaluation for KOSDAQ listing with grades of A and BBB from two evaluation agencies. As the technical evaluation threshold for biotech companies has recently become more stringent, Inventera's successful technical evaluation is seen as reaffirming both its technological capabilities and business potential.

Chief Executive Officer Shin Taehyun stated, "This domestic phase 3 IND approval for INV-002 is a decisive milestone that proves Inventera's technological prowess and market competitiveness," adding, "As INV-002 is the world's first iron-based T1-MRI contrast agent developed with purely domestic technology, we will accelerate not only its successful commercialization but also its entry into the global market."