Drug
C21 (Buloxibutid)
Status:
Phase 2
Condition:
Idiopathic Pulmonary Fibrosis
Intervention Type:
Oral Drug
Funder Type:
Industry
Drug Detail
Buloxibutid is an oral angiotensin II type 2 (AT2) receptor agonist and has been shown to improve lung function in IPF over 36 weeks. Buloxibutid agonizes the AT2 receptor on alveolar epithelial type 2 cells (AEC2s), which are believed to play a central role in the disease. Buloxibutid has been demonstrated preclinically to improve AEC2 viability, alveolar integrity via surfactant secretion, and epithelial repair via replenishment of gas exchange alveolar epithelial type 1 cells (AEC1s). This leads to decreasing downstream profibrotic signaling, enhancing the resolution of existing fibrotic tissue via upregulation of collagenase matrix metalloproteinases, and addressing vascular dysfunction associated with the disease.
Study Purpose
The ASPIRE trial is a 52-week randomized, double-blind, placebo-controlled, parallel-group, multicenter trial in which the efficacy, safety, and pharmacokinetics of orally administered buloxibutid, either on top of stable IPF therapy or as monotherapy, are assessed in participants with IPF.