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March 12, 2021

LoA Update: Arena’s olorinab FDA approval shot in IBS-associated pain drops five points to 2% due to Phase IIb trial fail

Arena Pharmaceuticals’ Phase IIb olorinab for abdominal pain due to irritable bowel syndrome (IBS) saw a five-point drop in its FDA likelihood of approval (LoA) as of 4 March.

By Reynald Castañeda

Arena Pharmaceuticals’ Phase IIb olorinab for abdominal pain due to irritable bowel syndrome (IBS) saw a five-point drop in its FDA likelihood of approval (LoA) as of 4 March. The LoA decrease is due to the Phase IIb CAPTIVATE trial not meeting its primary efficacy endpoint of average abnormal pain score (AAPS) improvements versus placebo measured in a 12-week timeframe, as revealed in a 2 March media release.

Olorinab already had a low LoA of 7%, which dropped further to 2% due to CAPTIVATE data, according to GlobalData analysis using a combination of machine learning and its proprietary algorithm. While the 273-patient CAPTIVATE did not succeed in its primary endpoint, subgroup analysis shows 50mg olorinab may offer relief in patients with moderate-to-severe pain, with the company indicating it expects to evaluate possible strategic options for the asset, as per the media release.

On 26 March 2020, this news service reported olorinab’s positive Phase IIa data in Crohn’s disease may have limited bearing on CAPTIVATE’s potential for trial success. The 14-patient Crohn’s disease trial is too small to gauge the drug’s overall efficacy prospects, experts said, and the two indications have different etiologies and possibly sources of pain. Olorinab targets cannabinoid receptor type 2 (CB2). Arena has a market cap of $4.49bn.

Reynald Castaneda is an Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.

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