Zealand banks on convenience
Is a convenience advantage – and a lesser one than had been hoped for – enough to take on the market leader? Zealand Pharma has to hope so following the so-so data it reported today from the phase 3 Ease SBS 1 study of glepaglutide in short bowel syndrome. Injected once a week, the GLP-2 agonist appears to be a washout, whereas when given twice-weekly it was roughly in line with Gattex, Takeda’s market leader, on measures relating to the reduction of intravenous nutrition. Still, Gattex is injected daily, so glepa could offer a slightly more palatable administration schedule. Whether this justifies the 28% uptick in Zealand’s stock today is open to question, particularly since generic versions of Gattex could enter the US market next year. For now the company is planning its NDA submission as it awaits data from two long-term extension trials, Ease SBS 2 and Ease SBS 3.
| The long and the short of it: cross-trial comparison of glepaglutide and Gattex in short bowel syndrome | |||
|---|---|---|---|
| Glepaglutide 10mg once weekly | Glepaglutide 10mg twice weekly | Gattex 0.05mg/kg once daily | |
| Trial | Ease SBS 1 | Steps | |
| Placebo-adjusted clinical response* | 7% | 27% | 33% |
| P value vs placebo | Not given | 0.0243 | 0.002 |
| Placebo-adj avg reduction in parenteral support at 24wk (litres/wk) | 0.28 | 2.3 | 2.1 |
| P value vs placebo | Not sig | 0.0039 | 0.001 |
| Proportion achieving independence from parenteral support (enteral autonomy) | 11%** | 14% | 6%^ |
| *Defined as >20% reduction in parenteral support volume at 20 and 24wk. **Vantage calculation. ^Vantage calculation, data from Steps 2 extension trial. Source: company communications & FDA. | |||
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