Ildong Pharmaceutical announced on the 13th that its research and development subsidiary, iLeadBMS, has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its new drug candidate 'IL21120033' currently under development for idiopathic pulmonary fibrosis (IPF).
IL21120033 is a drug candidate targeting CXCR7, which is closely involved in the fibrosis and inflammation of biological tissues among immune-related signaling proteins known as chemokine receptors.
CXCR7 is a key mediator in the signaling involved in inflammation, selectively binding to the chemokine receptor ligand CXCL12 to regulate various signaling pathways related to tissue repair, angiogenesis, and fibrosis.
IL21120033 selectively binds to CXCR7, removing the inflammation-causing factor CXCL12 within cells, demonstrating anti-inflammatory and anti-fibrotic effects. Preclinical study results also showed that IL21120033 selectively bound to CXCR7 without associating with other chemokine receptors and displayed ideal pharmacokinetic properties when administered orally.
In particular, in animal tests using bleomycin, an anti-cancer agent, to induce pulmonary fibrosis, IL21120033 showed improved results in indicators measuring pulmonary fibrosis and superior anti-fibrotic efficacy compared to existing standard treatments.
As there were minimal side effects of existing treatments, including weight loss, during animal experiments with IL21120033, the company expects it to meet safety requirements.
Yoon Seok, Chief Scientific Officer (CSO) of iLeadBMS, noted, 'Through our research to date, we have confirmed the anti-fibrotic efficacy of IL21120033.' He added, 'With the orphan drug designation by the FDA recognizing the value and potential of this new drug substance, we plan to expedite all necessary work for subsequent clinical development, including safety evaluation (GLP) and submission of an investigational new drug application (IND).'