Arena Pharma (ARNA) reported earnings on Mon 9 Nov 20 (a/h)

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Arena Pharm beats by $0.17, misses on revs, provides clinical program update

• Reports Q3 (Sep) loss of $(1.69) per share, $0.17 better than the S&P Capital IQ Consensus of ($1.86); revenues fell 98.5% year/year to $0.02 mln vs the $1.43 mln S&P Capital IQConsensus.

Program Updates:

• Etrasimod atopic dermatitis (AD) ADVISE Phase 2b trial delivered topline results; moving forward into a Phase 3 registrational program
• Etrasimod ELEVATE UC 52 Phase 3 trial in ulcerative colitis (UC) ongoing and on track to complete enrollment by year-end 2020, with the 52-week treatment period ending by year-end2021 and data expected shortly thereafter; ELEVATE UC 12 Phase 3 trial was initiated, continues to make strong progress with data expected in the same timeframe as UC 52; we continue to monitor the impact of the COVID-19 resurgence on study enrollment for both UC52 and UC 12
• Etrasimod GLADIATOR UC Phase 2 planning; initiation expected in Q1 2021 dependent onCOVID-19 impact
• Etrasimod CULTIVATE Phase 2/3 trial in Crohn's disease (CD) ongoing; confirming topline dose-ranging data in 2021; continue to suspend overall program guidance based on COVID-19impact
• Etrasimod eosinophilic esophagitis (EoE) Phase 2b VOYAGE trial with initiation expected in 2020but dependent on COVID-19 impact
• Etrasimod alopecia areata (AA) Phase 2 initiated; topline data expected H2 2021
• Olorinab CAPTIVATE Phase 2b trial in abdominal pain associated with irritable bowel syndrome(IBS-C, IBS-D) enrollment completed; topline data expected Q1 2021
• APD418 in acute heart failure (AHF) with Fast Track designation; completed the first-in-human Phase 1 trial; APD418 was generally well tolerated; Phase 2 planning ongoing

Arena Pharm announces top-line results from Phase 2b ADVISE trial evaluating etrasimod for the treatment of moderate-to-severe atopic dermatitis; primary endpoint not met

• Arena Pharmaceuticals today announced top-line results from the Phase 2b ADVISE clinical trial evaluating etrasimod, a highly selective, once-daily, oral sphingosine 1-phosphate (S1P)receptor modulator, for the treatment of moderate-to-severe atopic dermatitis (AD).
• In the ADVISE trial, the participants were representative of a moderate patient population(82.9% baseline vIGA 3). In the primary analysis, nearly one-third of participants in the 2 mgetrasimod group achieved clear or almost clear skin, as defined by the validated Investigator Global Assessment (vIGA) -- the FDA endpoint for Phase 3 registration. Importantly, the vIGA improvement was statistically significant vs. placebo at 12 weeks. Across the Eczema Area and Severity Index (EASI), EASI-75 and peak change in pruritis, etrasimod 2 mg demonstrated early and statistically significant effect at week 4.
• Etrasimod did not meet the Ph 2b primary endpoint of EASI change from baseline at week 12 as compared to placebo.
• Overall, the 12-week study showed no plateau of effect, and the safety profile was consistent with previous trials of etrasimod including low first dose heart rate effect with no titration, and no serious adverse events across the groups.
• Between weeks 4-8, the trial was impacted by unwarranted dose interruption (not related to drug safety) in 19% of the etrasimod 2 mg group. Adjusting for this dose interruption --a post-hoc Completer Analysis with participants receiving full therapeutic exposure -- etrasimod2 mg showed statistically significant effect on the EASI score compared to placebo (weeks 4and 12), EASI-75 at week 4, vIGA at week 12, and pruritis through week 8.