Gossamer Bio Announces GB004 Topline Results from Phase 2 SHIFT-UC Study in Ulcerative Colitis and Provides Corporate Update
25 Apr 2022
Colitis, UlcerativeAKB-4924Collaborate
Gossamer Bio (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced topline results from its Phase 2 SHIFT-UC Study clinical trial studying GB004 in patients with mild-to-moderate active ulcerative colitis (UC).
Neither GB004 treatment arm met the primary or secondary endpoints at week 12. Based on the totality of the available data, Gossamer will terminate the ongoing treat-through and open-label extension portions of the Phase 2 SHIFT-UC Study for lack of treatment benefit.
“While we are disappointed with these results, we want to thank the patients, caregivers and investigators who participated in and contributed to this clinical trial,” said Faheem Hasnain, Co-Founder, Chairman and Chief Executive Officer of Gossamer Bio.
“I am proud of our team’s efforts in trying to advance a new mechanism of action for patients with ulcerative colitis. Looking forward, we are eagerly anticipating topline results from our Phase 2 TORREY Study of seralutinib in PAH in the fourth quarter and the initiation of our Phase 1b/2 STAR CNS Study of GB5121 in patients with primary CNS lymphoma later this quarter.”
The Phase 2 SHIFT-UC Study (NCT04556383) enrolled 236 patients with mild-to-moderate active UC who were treatment naïve to approved biologic therapies. The clinical trial assessed the effects of GB004 added to background therapy of 5-aminosalicylate (5-ASA) with or without systemic steroids during a 36-week placebo-controlled period and a 24-week open-label extension period. In the placebo-controlled period, two active dose regimens of GB004 were compared to placebo (GB004 480mg once-daily [QD], n = 78; GB004 480mg twice-daily [BID], n = 80; placebo, n = 78). The primary endpoint was the proportion of participants with clinical remission, as defined by the modified Mayo Score, at week 12.
Neither statistically significant nor clinically meaningful differences were observed for the primary endpoint at week 12 (GB004 480mg QD: 15.4%; GB004 480mg BID: 22.5%; placebo: 17.9%). There were also no meaningful differences in secondary endpoints, including histologic and mucosal healing endpoints, for either GB004 treatment group relative to placebo at week 12. An assessment of available 36-week data showed no meaningful improvement on efficacy endpoints.
The safety and tolerability pro GB004 observed in the trial was generally consistent with prior clinical trials. Dizziness, nausea and somnolence were the most commonly reported adverse events among GB004-treated patients, with incidences higher than placebo. Adverse events were generally mild in severity.
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