Eiger announces Phase 2 PREVENT study met primary efficacy endpoint
Eiger BioPharmaceuticals announced Phase 2 PREVENT study results in an oral presentation at ENDO 2019 in New Orleans. PREVENT is a multi-center, placebo-controlled, outpatient study investigating the safety and durability of 28-day dosing of avexitide subcutaneous injections in post-bariatric surgical patients who experience chronic, dangerously low, postprandial blood glucose levels, known as post-bariatric hypoglycemia or PBH. The primary efficacy endpoint of improved postprandial glucose nadir during mixed meal tolerance testing was achieved with statistical significance with avexitide 30 mg BID and 60 mg QD, with fewer participants requiring glycemic rescue during each of the active dosing regimens than during placebo dosing. The secondary endpoint of reduced postprandial insulin peak during MMTT was also statistically significant with avexitide 30 mg BID and 60 mg QD. Improvements in metabolic and clinical parameters were also monitored during each patients' daily routine in the outpatient setting and assessed by self-blood glucose monitoring, electronic diary, and continuous glucose monitoring. Patients experienced fewer episodes of hypoglycemia, severe hypoglycemia and a reduced rate of rescue during both dosing regimens of avexitide as compared to placebo. Rescue is defined as self- or third-party administration of oral or g-tube intake to prevent or treat hypoglycemia. Patients also demonstrated reductions in percent time in hypoglycemia during diurnal periods and number of episodes of hypoglycemia as measured by CGM. Avexitide was well-tolerated in this study. There were no treatment-related serious adverse events and no participant withdrawals. Adverse events were typically mild to moderate in severity. The most common adverse events were injection site bruising, nausea, and headache, all of which occurred with lower frequency during avexitide dosing periods than during the placebo dosing period.