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Agios Pharma (AGIO) to complete Phase 2 study of AG-348 in Patients With Pyruvate Kinase Deficiency in Q3 2017
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- The majority of treatment-related adverse events (AEs) were Grade 1-2; the most frequent were headache, insomnia and nausea.
- Three patients experienced treatment related AEs leading to discontinuation: chest discomfort/pleural effusion (n=1), pharyngitis/nausea (n=1) and anemia (n=1).
- Five patients experienced drug-related serious adverse events: withdrawal hemolysis followed by anemia (n=1), anemia (n=1), osteoporosis (n=1), hypertriglyceridemia (n=1) and pharyngitis (n=1).
° Grade 4 hypertriglyceridemia at week 24 resolved upon AG-348 discontinuation (patient had Grade 1 hypertriglyceridemia at baseline).
- Preliminary measurements of testosterone in men suggest aromatase inhibition by AG-348 with the majority of testosterone changes remaining within the normal range. Longer follow-up is required to assess clinical significance.
- In patients who had Hb increases of >1.0 g/dL, the mean maximum Hb increase was 3.5 g/dL (range 1.1-5.8 g/dL).
- The median time to a Hb increase of >1.0 g/dL was 10 days (range 7–141 days).
- Median baseline Hb in patients who experienced a maximum Hb increase of >1.0 g/dL was 9.7 g/dL (range 7.5–12.3 g/dL) vs. 8.0 g/dL (range 6.5–10.1 g/dL) in patients who did not experience the increase.
- In patients with a Hb increase of >1.0 g/dL improvements in hemolysis associated parameters were observed:
° An increase in haptoglobin and decrease in lactate dehydrogenase (LDH) were observed in the first weeks of dosing.
° Rapid decreases in reticulocytes were observed.
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Dec 12, 2017
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Related Keywords Phase 2 Study, Ag-348, Pyruvate Kinase Deficiency, Pk Deficiency, Open Label