[Edaily Reporter KIM SAE-MI ] #Inventera Inc. is moving forward with U.S. clinical trials for “INV-003,” a nano-magnetic resonance imaging (MRI) contrast agent specifically designed for magnetic resonance cholangiopancreatography (MRCP).

Inventera Inc. announced on the 17th that it has submitted an Investigational New Drug (IND) application for INV-003 to the U.S. Food and Drug Administration (FDA). This is a follow-up step after the company completed its preclinical trial package last June.

INV-003 is an oral, iron oxide-based T2-MRI contrast agent currently under development to improve the image quality and diagnostic accuracy of MRCP examinations. MRCP is a non-invasive procedure that uses MRI to visualize the structures of the pancreatic and bile ducts; it is used to diagnose and evaluate conditions such as gallstones, cholangitis, pancreatitis, bile duct and pancreatic duct strictures, and tumors of the hepatopancreatic tract.

This Phase 1 clinical trial is scheduled to enroll up to 30 adults who require an MRCP examination for follow-up or differential diagnosis. Participants will receive a single oral dose of INV-003 in an open-label, single-dose, stepwise dose-escalation design, and the study will evaluate safety and tolerability, including dose-limiting toxicity (DLT).

Through this study, Inventera Inc. plans to identify the maximum tolerated dose (MTD) and determine the recommended Phase 2 dose (RP2D). The efficacy of INV-003 as assessed by MRCP imaging will also be evaluated.

MRCP utilizes the characteristic that digestive fluids inside the pancreatic and biliary ducts appear bright on MRI images. However, the bright signal from the pancreatic and biliary ducts can overlap with the signal from digestive fluids in the stomach and duodenum, potentially hindering the observation or interpretation of fine structures.

INV-003 is designed to selectively suppress signals from the stomach and duodenum, allowing for clearer visualization of pancreatic and biliary duct structures. By applying Inventera Inc.’s “Invinity” nanopharmaceutical platform technology, the drug aims to achieve stable dispersion and signal suppression performance even in the highly acidic environment of the stomach.

An Inventera Inc. official stated, “Through this clinical trial, we will evaluate safety and efficacy and confirm its clinical value as a first-in-class contrast agent,” adding, “We plan to submit an IND application for INV-003’s Phase 1 clinical trial to the Ministry of Food and Drug Safety within this year.”