NGM roars forward in Nash race

Snippets

In a space where failure is commonplace NGM Bio yesterday bucked the trend, reporting positive phase II Nash data from the fourth cohort of a phase II study of aldafermin (NGM282), sending shares up by 16%. Investor focus was on aldafermin’s reductions in liver fibrosis and inflammation – 22% of patients in the aldafermin arm, versus none in the placebo arm, achieved the composite endpoint of both fibrosis improvement and resolution of NASH. NGM’s success here could differentiate it from other Nash projects and help mitigate not only the inconvenient once-daily injection schedule that aldafermin requires, but also the LDL concerns, which NGM says can be managed with statins. Hopes are also rising for the phase IIb Alpine 2/3 study of aldafermin, although the sheer number of ongoing Nash trials means that the group is struggling to find patients; study completion has been pushed out from 2020 to early in 2021. NGM lags the most advanced Nash player, Intercept, whose Ocaliva faces an advisory panel on April 22, though perhaps this will not matter in the end. Stifel analysts believe that the latest data from NGM compare very favourably to Ocaliva, and arguably look even better on fibrosis benefit.

Data from phase II Cohort 4 study
  Aldafermin 1 mg Placebo
Number of patients 50 22
Fibrosis improvement (≥1 stage) with no worsening of Nash 38%  18%
Resolution of Nash with no worsening of liver fibrosis 24% 9%
Fibrosis improvement and resolution of Nash 22%* 0%
NAS reduction of ≥2 points with no worsening of liver fibrosis 62%* 9%
Source company statement; *p<0.05.

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