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GRI Bio (GRI) investor relations material
GRI Bio H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Program updates and clinical milestones
Lead program GRI-0621 is in a Phase 2A study for idiopathic pulmonary fibrosis (IPF), with top-line data expected later this month.
GRI-0803, focused on systemic lupus erythematosus, will advance through IND and Phase 1 next year.
Additional clinical-stage assets and a pipeline of 500 proprietary compounds are available for future development.
Positive interim data for GRI-0621 after two and six weeks of therapy in IPF patients.
Next steps may include a Phase 2B pivotal study if current results are successful.
Scientific insights and technology platform
NKT cell modulators regulate both adaptive and innate immune responses, offering a selective approach to immunomodulation.
Elevated NKT cell levels correlate with disease progression in IPF, lupus, and other fibrotic conditions.
GRI-0621 targets key fibrotic pathways, including TGF beta and IL-13, to inhibit fibrosis.
Preclinical models show GRI-0621 outperforms nintedanib in reducing fibrosis and related biomarkers.
GRI-0803 activates regulatory dNKT cells, showing efficacy in lupus animal models.
Clinical study design and biomarker analysis
Phase 2A IPF study enrolled 36 patients, allowing background therapy with approved drugs.
Primary endpoint is safety, with extensive biomarker, gene expression, and flow cytometry analysis.
Serum biomarkers of collagen synthesis and degradation provide early insight into fibrosis progression or resolution.
Data show decreased collagen synthesis, increased degradation, and signs of lung repair.
Biomarker and gene expression data will inform the design of future studies.
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