GOSS - Gossamer Bio says mid-stage trial for ulcerative colitis therapy did not meet main goals

Gossamer Bio (NASDAQ:GOSS) has lost ~9% in the pre-market Monday after the clincal stage biotech said that its Phase 2 study for GB004 in mild-to-moderate active ulcerative colitis (UC) did not meet the primary or secondary endpoints at week 12. The 236-patient trial was designed to evaluate two active dose regimens of GB004 compared to the placebo. Neither treatment arm showed statistically significant or clinically meaningful differences in the primary endpoint of the percentage of patients with clinical remission, as defined by the modified Mayo Score, at week 12. There were no meaningful differences for the secondary endpoints for any of the GB004 treatment groups. Even 36-week data showed no meaningful improvement to efficacy levels, the company said, adding that safety and tolerability profile of GB004 was inline with prior clinical findings. Dizziness, nausea and somnolence were among the most commonly cited adverse events with a higher level of incidence than the

For further details see:

Gossamer Bio says mid-stage trial for ulcerative colitis therapy did not meet main goals