The board of directors of the CANbridge Pharmaceuticals Inc. informed the shareholders and potential investors of the Company that preliminary clinical data of the ongoing Phase 1b study of Omoprubart (CAN106), a novel, long-acting, anti-Complement component 5 (C5) complement recombinant humanized monoclonal antibody, in paroxysmal nocturnal hemoglobinuria (PNH) in China has been announced. In this 26-week, multicenter, open-label, dose ascending trial in 16 PNH patients who have not received complement-inhibitor treatment, Omoprubart was administered intravenously every four weeks at three different maintenance doses after a loading dose period. Data from the two lower dose cohorts was reviewed through 26 weeks, while data from the highest dose cohort was reviewed through 13 weeks, the latest timepoint.

Omoprubart treatment resulted in rapid, dose-dependent reductions in lactate dehydrogenase (LDH) from baseline, with mean LDH reductions of 49% in Cohort 1, 73% in Cohort 2, and 81% in Cohort 3. The percentage of subjects reaching an LDH level less than 1.5 times the upper limit of normal, the therapeutic goal for hemolysis inhibition with an anti-C5 antibody, at least once during the study was 25% in Cohort 1, 50% in Cohort 2,and 88% in Cohort 3. Hemoglobin levels increased across all study cohorts, with mean increases from baseline of approximately 2 g/dL in Cohorts 1 and 2 at Week 26, and 1 g/dL in Cohort 3 at Week 13. All subjects in Cohort 1 have been treated with Omoprubart for over one year, with a mean hemoglobin increase of approximately 4 g/dL from baseline. Patients with PNH often require frequent blood transfusions to treat severe anemia due to hemolysis.

Omoprubart was safe and well-tolerated at all doses. All drug-related adverse events were mild or moderate and transient, and none led to discontinuation from the study. There were no drug-related serious adverse events, and no cases of anaphylaxis or meningococcal infection.