Leerink Affirms Celgene (CELG) at 'Market Perform'; Doesn't see Strong Mongersen Phase 2 Data Translating to Phase 3

September 12, 2016 11:31 AM EDT
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Leerink affirms Celgene Corporation (Nasdaq: CELG) at Market Perform with a price target of $135 after the company announced interim topline data from a randomized, double-blind, multicenter, exploratory phase 1b study evaluating the effects of oral GED-0301 (mongersen) on both endoscopic and clinical outcomes in patients with active Crohn’s disease.

The firm commented, At baseline, patients with Crohn’s required a SES-CD above 7, but we note the score can range from 0-60, which makes it difficult to calculate the significance of a 25% reduction. The results also described that mongersen produced clinical remission for an undefined number of patients at week 4 using a patient-reported clinical remission endpoint, compared to the 72% rate of remission reported in the previous IGON-1 phase 2 trial that lacked endoscopy confirmation.

In our view, while the drug could be active in some patients, it seems that the impressive data from the previous phase 2 trial will not translate to the phase 3 patient population, or to the real world which mainly consists of patients with active, longstanding, treatment resistant disease, similar to today’s endoscopy trial patients. Importantly, however, the relatively clean safety profile reported from previous studies was apparently maintained in this study. We spoke with Celgene this morning, and the company stated that there would be no changes to ongoing and planned phase 3 trials as a result of this analysis.

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