C103-23 Buloxibutid’s Efficacy in the Phase 2a Air IPF Trial: Comparative Analysis of Baseline Characteristics of Indian Versus World Cohorts

Rationale Buloxibutid is a first-in-class angiotensin II type 2 (AT2) receptor agonist in clinical development for idiopathic pulmonary fibrosis (IPF). The Phase 2a AIR trial investigated the safety and efficacy of buloxibutid over 36 weeks in IPF, showing stabilisation and improvement of lung function. Given that many patients were enrolled from India, this analysis explored potential regional differences that could influence treatment response. Methods Patients enrolled in the Phase 2a AIR study were treated twice daily with 100mg of buloxibutid for up to 36 weeks. Of the 48 AIR patients included in the efficacy analysis, 38 were from India. An external dataset of 1,127 treatment-naive IPF patients from six world regions was selected for comparison on baseline characteristics. Cohorts were compared on a set of seven clinical and two high-resolution computed tomography (HRCT) baseline features (Figure 1A). Lung Volume (L) and Fibrosis volume (%) were derived from HRCT scans using 3D convolutional neural networks (Lung8™ and Fibr8™). Isomap dimensionality reduction was used to compare visually the distributions in two dimensions. Results Dimensionality reduction of baseline clinical and HRCT features demonstrated substantial overlap between the Indian cohort and the global IPF population (Figure 1B). Quantitative comparisons of the baseline characteristics (Figure 1C) showed similarity on sex, gender distribution, percent predicted FVC and FEV1. Differences were observed on absolute lung function parameters, HRCT lung volume and fibrosis percentage however the observed values for the Indian cohort remain within the ranges of the global distribution. Conclusions Dimensionality reduction analysis confirmed that the Indian subgroup falls within the global distribution of clinical and HRCT features. Regional variability was noted across certain imaging or physiological dimensions, consistent with the natural heterogeneity of IPF. These findings support the overall generalizability of AIR trial results while underscoring the value of regionally diverse enrolment in future studies. Buloxibutid is currently being investigated in a global 52-week Phase 2b study (ASPIRE) enrolling patients across 14 different countries. This abstract is funded by: Qureight Ltd, Vicore Pharma