Late Breaking Abstract - PMG1015 demonstrates well-tolerated safety and favorable FVC changes after 12 weeks of treatment in IPF Patients

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Background: Sustained Amphiregulin (AREG) expression from persistent intermediate alveolar epithelial stem cells drives pulmonary fibrosis. PMG1015, a first-in-class antibody targeting AREG, is under development for IPF. Objectives: PMG1015 was administered as monotherapy in a Phase Ib study ( NCT05895565 ) in IPF patients to assess safety, tolerability, PK, immunogenicity, and target engagement. Methods: This multicenter, randomized, double-blinded, placebo-controlled study enrolled IPF patients who received three doses of PMG1015 (5, 15, and 30 mg/kg) or placebo. In addition to safety, PK, immunogenicity, and target engagement, changes in FVC and CT imaging biomarkers were analyzed. Results: 29 patients were enrolled, with 25 receiving PMG1015 and 4 receiving placebo. PMG1015 was well tolerated with no dose-related AEs. The incidence of TEAEs was comparable between the PMG1015 and placebo groups. No drug-related TEAEs led to discontinuation. PMG1015 exhibited a linear and dose-proportional PK profile across the 5 to 30 mg/kg dose range, with no baseline or treatment-emergent ADAs. Target engagement was confirmed with >98% receptor occupancy at all doses. At week 12, FVC improved by a mean of 96.9 ml in the pooled PMG1015 group corrected for placebo. On CT, lung volume increased by 221.7 ml (p=0.15) and ground glass volume significantly decreased by -1.02% (p=0.031) in the pooled PMG1015 group corrected for placebo. Conclusions: PMG1015 demonstrated excellent safety and tolerability with minimal immunogenicity in IPF patients. The favorable FVC and CT imaging changes support continued clinical development of PMG1015 as a monotherapy or combination therapy for IPF.

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