On March 15, 2023 Cortalix BV reported that the company acquires patents and know-how from BiOrion on its single domain antibody platform and fibrogenesis biomarker radiopharmaceuticals (Press release, Cortalix, MAR 15, 2023, View Source [SID1234638786]).

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With these patents and know-how, Cortalix can continue to work on 2 active clinical programs around PET imaging of fibrogenesis, the active stage of organ fibrosis. The company recently completed a first clinical PET imaging study in humans following a basket design clinical trial in patients suffering from organ fibrosis. It was found that especially patients with a history of conditions associated with cardiac fibrosis showed a clear uptake of 68-Gallium-BOT5035 in typical heart regions within 60 minutes after administration, while this was not the case in patients without a history of heart disease. A follow-up phase 2 study will soon start in heart failure patients with conserved ejection fraction (HFpEF). A third phase 2 PET-imaging study is expected to start in Q1 2024 in patients suffering from idiopathic pulmonary fibrosis (IPF) in collaboration with a consortium of US major pharmaceutical companies.
In addition, Cortalix will soon start testing a 2nd generation fibrogenesis PET imaging diagnostic in patients with early-stage NASH/liver fibrosis, in collaboration with a consortium of US pharmaceutical companies and an imaging CRO.