Gossamer Bio Pulls Plug On Mid-Stage Ulcerative Colitis Program

  • Gossamer Bio Inc GOSS shares are falling after announcing topline results from its Phase 2 SHIFT-UC Study trial of GB004 in patients with mild-to-moderate active ulcerative colitis (UC).
  • Neither GB004 treatment arm met the primary or secondary endpoints at week 12. 
  • Gossamer will terminate the ongoing treat-through and open-label extension portions of the Phase 2 SHIFT-UC Study for lack of treatment benefit.
  • In the placebo-controlled period, two active dose regimens of GB004 were compared to placebo. The primary endpoint was the proportion of participants with clinical remission.
  • Neither statistically significant nor clinically meaningful differences were observed for the primary endpoint at week 12. 
  • There were no meaningful differences in secondary endpoints, including histologic and mucosal healing endpoints, for either GB004 treatment group relative to placebo at week 12. 
  • The Company has seralutinib (GB002) Phase 2 TORREY Study in pulmonary arterial hypertension with topline data expected in Q4 of 2022.
  • As of March 31, 2022, Gossamer estimates that its cash, cash equivalents, and marketable securities were approximately $272 million.
  • Price Action: GOSS shares 10.7% at $7.86 during the premarket session on the last check Monday.

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