Gossamer Bio Announces GB004 Topline Results from Phase 2 SHIFT-UC Study in Ulcerative Colitis and Provides Corporate Update
— Study did not meet primary or secondary endpoints at week 12 —
— GB004 Phase 2 SHIFT-UC Study to be terminated for lack of treatment benefit —
— Target enrollment reached in Phase 2 TORREY Study of seralutinib in PAH; topline results expected in 4Q22 —
— As of
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
“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
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 profile of 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.
Seralutinib (GB002) Phase 2 TORREY Study in pulmonary arterial hypertension (PAH) enrolled its 80th patient in
Topline results from ongoing Phase 2 TORREY Study are expected to be released in the fourth quarter of 2022.
March 31, 2022, Gossamer estimates that its cash, cash equivalents and marketable securities were approximately $272 million.
Conference Call and Webcast
Gossamer’s management team will host a conference call and live audio webcast at
The live audio webcast may be accessed through the “Events / Presentations” page in the “Investors” section of the Company's website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:
Conference ID: 2924955
International Dial-in Number: (929) 517-9782
Live Webcast: https://edge.media-server.com/mmc/p/rizdexja
A replay of the audio webcast will be available for 30 days on the “Investors” section of the Company's website, www.gossamerbio.com.
Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the termination of the Phase 2 SHIFT-UC trial; the anticipated timing of initiation and enrollment of clinical trials for our product candidates, including the expected initiation of the Phase 1b/2 STAR CNS study of GB5121 in patients with primary CNS lymphoma; plans to advance our product candidates; expectations on the timing of data readouts from our clinical studies, including the timing of topline results for the Phase 2 TORREY study for seralutinib; and the Company’s estimated cash and cash equivalents as of
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