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CohBar (NASDAQ:CWBR) has announced it will be resuming its Phase 1a/1b clinical trial of CB4211 after concluding conversations with the US Food and Drug Administration (FDA). As quoted in the press release: “We are working with our clinical partner to resume dosing as soon as possible,” said Philippe Calais, CohBar’s interim CEO. “We are excited …
CohBar (NASDAQ:CWBR) has announced it will be resuming its Phase 1a/1b clinical trial of CB4211 after concluding conversations with the US Food and Drug Administration (FDA).
As quoted in the press release:
“We are working with our clinical partner to resume dosing as soon as possible,” said Philippe Calais, CohBar’s interim CEO. “We are excited to move forward with the clinical evaluation of CB4211, which we believe addresses a foundational event in the etiology of NASH, and as such has the potential to be an important therapeutic option for this increasingly epidemic disease.”
In November 2018, CohBar announced a temporary suspension of the CB4211 Phase 1a/1b study in order to address mild injection site reactions which became unexpectedly persistent. The company subsequently submitted to the FDA related data and documents, including an expert opinion on the absence of a serious safety concern, together with its amended clinical plan designed to address these reactions.