Gossamer hangs by a thread
Gossamer Bio may not be the worst-hit biotech today, but its 19% share price fall, on the back of a mid-stage failure in ulcerative colitis, is probably plenty bad enough. And that failure was total: GB004, an oral HIF-1α stabiliser, missed every endpoint in the Shift-UC trial. The placebo response was not unusually high in the trial, giving Gossamer nowhere to hide: as Richard Aranda, the group's chief medical officer, said on today’s conference call, “not hitting any primary or secondary endpoints tells us that the mechanism is just not … sufficient to treat a disease such as ulcerative colitis”. The project has been shelved. With Gossamer’s asthma and rhinosinusitis asset GB001 now apparently defunct, despite vague hopes that a partner would pick it up, the company is now reliant on seralutinib (GB002) showing a convincing effect in its ongoing phase 2 trial. Topline data from the Torrey study in pulmonary arterial hypertension are due in the fourth quarter. Gossamer insists that it has cash on hand to get it to that readout and beyond: its current $272m balance ought to last until late 2023 or early 2024.
|Phase 2 Shift-UC Study (NCT04556383)|
|GB004 480mg once-daily||GB004 480mg twice-daily||Placebo|
|% in clinical remission*||15.4||22.5||17.9|
|*As defined by the modified Mayo Score, at week 12. Source: company release.|