First Patient Dosed in GI Disorder-associated Pain Trial
Arena Pharmaceuticals announced that the first patient has been dosed in the phase 2 CAPTIVATE trial, according to a company press release.
The CAPTIVATE trial is expected to evaluate the safety and efficacy of three dose levels of olorinab for 12 weeks in approximately 240 patients experiencing abdominal pain associated with irritable bowel syndrome, including IBS with constipation or IBS with diarrhea.
“I am thrilled that the first [patient] has enrolled in [the] CAPTIVATE trial, supporting the advancement of novel pain management options within the digestive disease field,” Lin Chang, MD, professor of medicine at the Vatche and Tamar Manoukian Division of Digestive Diseases at the University of California, Los Angeles, said in the release. “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.”
APD371 (olorinab, Arena Pharmaceuticals) – an oral, peripherally restricted, highly selective, full agonist of the cannabinoid receptor 2 – has previously demonstrated positive safety and efficacy results for the treatment of Crohn’s disease associated with chronic abdominal pain.
The CAPTIVATE trial aims to evaluate the change in abdominal pain in patients with IBS with predominant constipation or diarrhea.
Improvement in the weekly Average Abdominal Pain Scale (AAPS) from baseline will serve as the primary endpoint.