Inventera, Musculoskeletal-Specific MRI Contrast Agent... "US 2b Phase IND Approval"

Inventera, a company developing new MRI contrast agents, announced on the 19th that it has recently obtained approval from the U.S. Food and Drug Administration (FDA) for the clinical Phase 2b trial plan (IND) of its musculoskeletal-specific MRI contrast agent new drug candidate INV-002.

Inventera is developing the world's first iron-based T1-MRI contrast agent. Through innovative nanomolecular structural design, it has developed a next-generation contrast agent platform technology that simultaneously satisfies high performance and safety. The company has discovered disease-specific MRI contrast agent pipelines that enable precise diagnosis of various diseases. In October this year, it secured an investment of 18.5 billion KRW through a Series C funding round.

The pipeline INV-002 (product name: NEMO-103), which received FDA clinical trial plan approval, is an MRI contrast agent new drug under development for use in joint arthrography (MR Arthrography) of the shoulder, hip, and knee joints. It provides superior contrast enhancement compared to existing gadolinium-based contrast agents, enabling highly precise diagnosis.

The FDA Phase 2b clinical trial will evaluate efficacy (contrast enhancement effect) and safety in 50 patients with shoulder diseases. The dosing of patients for the Phase 2b trial has already been completed domestically, and the clinical study report (CSR) is being prepared. It is expected that safety and efficacy in humans will be rapidly verified in the U.S. as well.

Based on the FDA Phase 2b approval, Inventera plans to accelerate its overseas expansion. The company will actively seek global partners for joint development and plans to select global research sites and principal investigators.

Additionally, MRI contrast agent candidates specialized for lymphography, INV-001, and for pancreatobiliary ductography, INV-003, are under development. INV-001 is currently in domestic Phase 1/2a clinical trials. The company is also preparing for a KOSDAQ initial public offering (IPO) targeted for the second half of next year.

Shin Taehyun, CEO of Inventera, stated, “FDA approval was a very important milestone for global expansion, and achieving this means that the quality of INV-002 and the completeness of nonclinical and clinical data have been validated at a global level.” He added, “This achievement has significantly increased the potential of INV-002 as a global new drug. Starting with entry into U.S. clinical trials, we will further strengthen our global competitiveness.”