DONGTAN, KOREA, February 13, 2025 - iLeadBMS, a spin-off biotech from Ildong Pharmaceutical Group, announced that it has received a notification from the US Food and Drug Administration (FDA) that its IL21120033, a first-in-class CXCR7 Agonist, has been granted Orphan Drug Designation (ODD) for treatment of idiopathic pulmonary fibrosis (IPF).
IPF is a rare lung disease
characterized by progressive fibrosis of lung parenchyma, with a less than 40%
survival rate five years after diagnosis. According to the National Institutes
of Health, IPF affects about 100,000 people in the United States and
approximately 30,000 to 40,000 new cases are diagnosed each year.
Unfortunately, IPF remains an incurable and fatal disease despite the use of
approved antifibrotic drugs. iLeadBMS is developing IL21120033 to address this high unmet medical
need.
CXCR7 is a key mediator in
signal transduction amplifying fibrosis and inflammation. CXCR7 selectively
binds to chemokine ligand CXCL12, targeting various pathways associated with
fibrosis, inflammation, tissue repair, and angiogenesis. This makes it an ideal
therapeutic target for treating fibrotic diseases, and iLeadBMS plans to
develop IL21120033 as an anti-fibrotic agent for
various organs including the lung, liver, heart, kidney, and skin.
IL21120033 has
exhibited high selectivity for CXCR7 without binding to other chemokine
receptors and demonstrated promising pharmacokinetics in mice and rats when
orally administered. In a bleomycin-induced pulmonary fibrosis model, IL21120033 showed dose-dependent
improvements in the Ashcroft score, confirming its potentially superior
anti-fibrotic efficacy compared to the standard therapy. Based on these results
the FDA has granted ODD for IPF.
“We are very pleased to
receive the Orphan Drug Designation from the FDA for IL21120033 for the
treatment of IPF,” said Dr. Yoon-seok Lee, CSO of iLeadBMS. “This provides
solid support for the development of IL21120033 for IPF as it has consistently demonstrated
strong anti-fibrotic efficacy in several IPF animal models.”
iLeadBMS plans to complete the
IND-enabling GLP toxicity studies this year.
About iLeadBMS
Established in 2020 as a
spin-off from Ildong Pharmaceuticals, iLeadBMS specializes in the discovery and
development of novel drugs with therapeutic focus in oncology, autoimmune and fibrotic
diseases. For more information, please visit https://www.ileadbms.com/ or https://www.linkedin.com/company/104793817.
About IL21120033
IL21120033 is a first-in-class
CXCR7 agonist that activates CXCR7 receptor which binds and reduces CXCL12, a
key pro-inflammatory factor under pathological conditions such as inflammation
and autoimmune diseases. CXCR7 agonist also indirectly inhibits CXCR4-CXCL12
signaling to prevent fibrosis and inflammation. Additionally, CXCR7 agonist
activates β-arrestin signal which can
promote regeneration and cell survival, making it a potentially disease
modifying agent. iLeadBMS is developing IL21120033 for various autoimmune and fibrotic
diseases where standard therapies are lacking or suboptimal.
