September 28, 2018
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Olorinab appears safe, effective for Crohn’s associated chronic pain

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Data from a phase 2a study centered on APD371 showed positive safety and efficacy results for the treatment of Crohn’s disease associated with chronic abdominal pain.

APD371 (olorinab, Arena Pharmaceuticals) – an oral, peripherally restricted, highly selective, full agonist of the cannabinoid receptor 2 – demonstrated reductions in pain within the first week of treatment and statistically significant improvement from baseline in Average Abdominal Pain Score (AAPS) was observed at weeks 4 and 8, according to a company press release.

“There is a strong clinical need for non-opiate treatments for the management of chronic abdominal pain in patients with gastrointestinal disorders, including Crohn’s disease, ulcerative colitis and irritable bowel syndrome,” Bruce Yacyshyn, MD, medical director for Inpatient Gastroenterology at UC Health University Hospital, said in the release. “The exciting results from this initial Phase 2a study in patients with Crohn’s disease leaves me optimistic for the potential of olorinab as a novel approach for the management of GI pain. I look forward to the further development of this interesting compound as an aid in the management of this complex group of patients.”

The study was a randomized, open-label, 8-week study that investigated 25 mg and 100 mg of APD371 administered three times a day. Each patient had a diagnosis of Crohn’s disease associated with chronic abdominal pain defined as a baseline AAPS of 4 or greater.

Fourteen patients were enrolled with a mean baseline AAPS of 5.6.

In the 11 patients evaluable at 8 weeks of treatment (baseline AAPS of 6), there was an improvement in AAPS of –4.6 (P < .001) from baseline.

At peak effect (1.5 hours post morning dose), 11 out of 13 patients with evaluable data at week 4, and 11 out of 11 patients with evaluable data at week 8, exhibited a clinically relevant improvement ( 30% change from baseline) in AAPS.

The improvement in pain was consistent at both doses, according to the release.

Preston Klassen, MD, MHS, chief medical officer of Arena Pharmaceuticals said that the intent of the study was to get information on safety, tolerability and the therapeutic potential of olorinab to reduce gastrointestinal pain in patients with Crohn’s disease and symptoms of chronic abdominal pain.

“Despite its small size and uncontrolled design, this trial provides early results that suggest a robust clinical response and supports continued, rapid development of olorinab, potentially targeting several diseases in which gastrointestinal pain is a hallmark,” Klassen said in the release.

Disclosures: Klassen is employed by Arena Pharmaceuticals. Healio Gastroenterology and Liver Disease was unable to determine Yacyshyn’s relevant financial disclosures at the time of publication.