Second Genome Inc. intends to leverage new understandings arising from research into the human microbiome about how microorganisms influence human disease and health. The start-up anticipates that its microbiome discovery platform will expose many possibilities for diagnosis and treatment of disease not previously connected with bacteria. Initially the start-up is intent on establishing that its methods can classify patients with irritable bowel syndrome and guide their treatment.
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
