Arena Pharmaceuticals announced the first subject has been dosed in the Phase 2 CAPTIVATE trial evaluating olorinab, an investigational, oral, highly-selective, full agonist of the cannabinoid type 2 receptor (CB2) in development for the treatment of visceral pain associated with gastrointestinal (GI) disorders. The trial will evaluate the efficacy and safety of three dose levels of olorinab for 12-weeks in approximately 240 subjects experiencing abdominal pain associated with IBS, including IBS with constipation (IBS-C) or IBS with diarrhea (IBS-D).

"I am thrilled that the first subject has enrolled in Arena's CAPTIVATE trial, supporting the advancement of novel pain management options within the digestive disease field," said Lin Chang, MD, Professor of Medicine at the Vatche and Tamar Manoukian Division of Digestive Diseases at the University of California, Los Angeles. "The majority of IBS patients describe their most problematic symptom as frequent abdominal pain, which often significantly impacts their quality of life. With limited pain management options available for GI disorders, there is a clear unmet medical need and an opportunity to improve the lives of patients."

"The initiation of the CAPTIVATE clinical trial is a significant milestone for Arena as we strategically expand our pipeline portfolio, with the goal of validating the broad potential impact of olorinab and ultimately delivering a novel option for chronic pain relief to patients worldwide," said Preston Klassen, MD, MHS, Executive Vice President, Research and Development and Chief Medical Officer of Arena. "We believe that olorinab has the potential to be a first-in-class therapy to address the strong clinical need to manage pain in patients with GI disorders, and we are committed to advancing the program expeditiously."

CAPTIVATE is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, 12-week study of olorinab in patients with irritable bowel syndrome (IBS), experiencing abdominal pain. The study will evaluate change in abdominal pain in patients with the clinical diagnosis of IBS with predominant constipation (IBS-C) or diarrhea (IBS-D). The primary objective of this trial is to assess the safety and efficacy of olorinab administered three times daily (TID). The primary endpoint is improvement in the weekly Average Abdominal Pain Scale (AAPS) from baseline. The CAPTIVATE trial will enroll approximately 240 patients and will be conducted in study sites across the United States.

Olorinab (APD371) is an oral, peripherally acting, highly-selective, full agonist of the cannabinoid type 2 receptor (CB2). Olorinab is an internally discovered investigational drug candidate that Arena is exploring for development in several indications, with an initial focus on visceral pain associated with gastrointestinal disorders. This compound, through its selectivity for CB2, versus cannabinoid type 1 receptor (CB1), is designed to provide pain relief without psychoactive adverse effects.

Olorinab is an investigational compound that is not approved for any use in any country.

Irritable bowel syndrome (IBS) is a common disorder of the gastrointestinal (GI) tract. Signs and symptoms include cramping, abdominal pain, bloating, gas, and predominant constipation (IBS-C) or diarrhea (IBS-D), or mixed (IBS-M). IBS is a chronic condition that needs to be managed long term. There are approximately 25 million patients in the United States with IBS, with approximately 80% reporting frequently recurring or continuous abdominal pain.

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