USA | Large Cap Pharma

研报英文原文证据摘录

USA | Large Cap Pharma

We caught up with ALKS mgmt recently + here are our key takes (1/2) –

Full NT2 Dataset At SLEEP

• ALKS does not expect the full NT2 presentation to materially change the interpretation of the MWT results already disclosed and believes it has already “characterized

the drivers” of the mean MWT outcomes. The company expects the most incremental insight to come from ESS severity-category analyses, OLE ESS data, cognition endpoints,

and fatigue endpoints.

• ALKS expects to present ESS data using clinically meaningful categories including normal, mild, moderate, and severe sleepiness. The company intends to show

baseline distributions, Week 8 distributions, and open-label extension distributions in order to demonstrate how patients move between sleepiness categories over time. ALKS

also intends to include both Week 8 and OLE timepoints to show how outcomes evolve longitudinally.

• Keep in mind, ALKS transitions patients onto active treatment during the open-label extension and expects to present OLE ESS data to show outcomes once all

patients receive active therapy. The company noted that both NT1 and NT2 patients entered the same extension study and said longer-term extension data could later be

presented at the European Sleep Congress.

• ALKS intends to include British Columbia Cognitive Complaints Inventory (BCCI) data and PROMIS Fatigue data in the NT2 presentation. The company sees a clearer

dose-response relationship in cognition and fatigue measures than in some primary efficacy endpoints and believes these findings are consistent with expectations for the NT2

population. ALKS also views these outcomes as supportive of expansion into additional indications.

NT2 Variability And Patient Response Patterns