[News Space=Reporter seungwon lee] The new mechanism of action innovative new drug candidate 'IL21120033' currently under development by iLeadBMS (CEO Jae-Jun Lee), a new drug research and development company of Ildong Pharmaceutical Group, has received orphan drug designation (ODD) for idiopathic pulmonary fibrosis (IPF) from the U.S. Food and Drug Administration (FDA).

IL21120033 is an anti-fibrotic new drug candidate based on a small molecule compound that acts on CXCR7 (CXC chemokine receptor 7), which is closely involved in inducing fibrosis and inflammation of living tissues among the receptors of chemokines, which are signaling proteins related to immunity.

CXCR7 is a key mediator of signal transduction involved in the development of inflammation, and selectively binds to the chemokine receptor ligand CXCL12 (CXC motif chemokine ligand 12) to regulate various signaling pathways related to tissue repair, angiogenesis, and fibrosis.

IL21120033 is a CXCR7 agonist drug that has high binding selectivity to CXCR7 and exhibits anti-inflammatory and anti-fibrotic effects by removing CXCL12, an inflammatory factor, within cells.

Preclinical studies showed that IL21120033 showed high selectivity for CXCR7 without binding to other chemokine receptors, and exhibited ideal pharmacodynamic properties when administered orally.

In particular, in an animal test of a bleomycin-induced pulmonary fibrosis model, IL21120033 dose-dependently improved the 'Ashcroft score', an indicator of pulmonary fibrosis, and showed superior anti-fibrotic efficacy compared to existing standard treatments.

Additionally, the company explained that safety requirements are expected to be met as side effects that are seen in existing treatments, such as weight loss, were not observed or were minimal in various animal experiments.

Lee Yoon-seok, Chief Scientific Officer (CSO) of IridBMS, said, “We have consistently confirmed the anti-fibrotic efficacy of IL21120033 through previous research,” and “Now that the value and potential of the new drug substance has been recognized through the FDA’s orphan drug designation, we plan to speed up all tasks for follow-up clinical development, such as safety assessment (GLP) and application for approval of the clinical trial plan (IND).”