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NGM Biopharma Announces its Phase 2b ALPINE 2/3 Study of Aldafermin in NASH Did Not Meet its Primary Endpoint, Will Not Pursue Phase 3 Clinical Development of Aldafermin in F2/F3


Benzinga | May 24, 2021 07:02AM EDT

NGM Biopharma Announces its Phase 2b ALPINE 2/3 Study of Aldafermin in NASH Did Not Meet its Primary Endpoint, Will Not Pursue Phase 3 Clinical Development of Aldafermin in F2/F3

* Study did not meet primary endpoint of fibrosis improvement by >1 stage with no worsening of NASH versus placebo

* Statistical significance achieved versus placebo on certain secondary endpoints, including NASH resolution (at the 3 mg dose) and multiple non-invasive measures of NASH, including liver fat content reduction by MRI-PDFF, ALT, AST and Pro-C3 (at the 1 mg and 3 mg doses)

* Aldafermin was generally well tolerated with an overall safety profile similar to placebo

* NGM plans not to pursue Phase 3 clinical development of aldafermin in F2/F3 NASH; will focus on its growing ophthalmology and oncology portfolio

* Company to host conference call and webcast today at 8:30 a.m. ET (5:30 a.m. PT)







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