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From the MD&A
Update on Phase 3 clinical trial evaluating tesamorelin in NASH − Discussions with the FDA and the EMA on the trial design are complete. − The Phase 3 clinical trial will include participants in the U.S. and Europe. − The Phase 3 clinical trial will be a multicenter, double-blind, placebocontrolled two-part study to evaluate the safety and efficacy of tesamorelin in liver-biopsy confirmed patients with NAS score of at least 4 and stage 2 or 3 fibrosis. − The Phase 3 clinical trial will include a futility analysis that will be performed after approximately 400 patients have completed 18 months of treatment and have received a second liver biopsy. − An sBLA is expected to be filed after approximately 1,100 patients, including approximately 75 to 100 people living with HIV, have completed 18 months of treatment and have received a second liver biopsy. − The primary endpoint will be NASH resolution and no worsening of fibrosis compared to placebo after 18 months as per FDA guidelines. − Following potential approval, an additional 1,800 patients are expected to be enrolled, to continue measuring clinical outcomes over a period of five years. − Based on regulatory discussions, the final Phase 3 clinical trial design will result in higher costs than what the Company had previously estimated. − As a result of the total cost of the Phase 3 clinical trial, the Company is now evaluating its options to best execute its late-stage development program, including seeking a potential partner. − An external U.S.-based biopharma advisory firm has been retained to assist in identifying a potential partner. − Partner identification and negotiations will alter the initiation of the Phase 3 clinical trial that was previously expected to begin in the third quarter of calendar year 2021. − See “Forward-Looking Information” above for some of the risks associated with the Phase 3 clinical trial. •