Inventera Secures Interim Phase 3 Results for Nano-MRI Contrast Agent 'INV-002'... Meets Key Endpoints

Inventera, a nanomedicine development company, has heightened expectations for commercialization as its core pipeline, the novel nano-MRI contrast agent "INV-002," met key evaluation criteria in the interim results of its domestic phase 3 clinical trial.

On May 14, Inventera announced that it had completed Last Patient Out (LPO) in the phase 3 clinical trial of INV-002 targeting patients with shoulder joint diseases, and subsequently submitted a clinical trial completion report to the Ministry of Food and Drug Safety (MFDS). The company also explained that it had obtained positive interim data from an Independent Image Review.

INV-002 is a new nano-MRI contrast agent candidate specialized for MR arthrography (MRA) in the diagnosis of musculoskeletal diseases. Currently, gadolinium-based contrast agents—raising safety concerns—are often diluted and used off-label in clinical settings for MRA examinations.

The company explained that INV-002 is expected to become a next-generation contrast agent that addresses the unmet needs of existing products, as it improves image quality and offers the convenience of not requiring a dilution process.

This phase 3 clinical trial was conducted at eight major tertiary hospitals in Korea. The first patient was dosed in September 2025 (First Patient In, FPI), and observation of the last subject was completed in April this year, about seven months later. Thereafter, the company submitted the clinical trial completion report to the MFDS in early May.

A total of 85 subjects participated in the trial. The interim results were derived based on the independent central image evaluation of the first 50 participants.

Independent central readers evaluated the MRA images using INV-002, with primary endpoints consisting of image quality indicators such as joint distension, contrast, and clarity.

The evaluation showed that MRA images using INV-002 demonstrated statistically significant differences in all primary endpoints compared to the control group. The company stated that statistically significant results (P-value < 0.0001) were confirmed for all items.

Additionally, distinct improvements were observed in secondary endpoints, including the Contrast-to-Noise Ratio (CNR) and Lesion-to-Background Ratio (LBR).

In particular, the company expects that, since statistically significant differences have already been confirmed in the data of more than half of the subjects (50 participants), positive results are highly likely to be maintained in the final statistical analysis.

This independent central image review was conducted by a panel of three external radiologists who did not directly participate in the clinical trial, thereby enhancing objectivity and reliability.

Currently, Inventera is proceeding with final clinical data analysis and preparation of the Clinical Study Report (CSR) through a contract research organization (CRO).

Tae-Hyun Shin, CEO of Inventera, stated, "Through these interim results, the imaging performance and clinical utility of INV-002 have been objectively confirmed. Having completed the phase 3 trial completion report, we plan to expedite the preparation of the Clinical Study Report."

He added, "We are preparing to submit a New Drug Application (NDA) to the MFDS in the second half of this year and will ensure a smooth transition to the approval and commercialization phases."

Inventera aims to strengthen the foundation for the approval and commercialization of INV-002 based on these interim phase 3 results, and to further enhance its competitiveness in the nano-MRI contrast agent market.

This content was produced with the assistance of AI translation services.