Arena Pharmaceuticals has been focused recently on researching and developing a non-opiate for the treatment of gastrointestinal pain. The drug, olorinab, is considered an investigational, peripherally restricted, highly selective, full agonist of the cannabinoid 2 (CB2) receptor.
A recent Phase 2a trial of olorinab resulted in positive topline results, following a randomized, open-label, eight-week study that investigated two different doses of the drug administered three times per day. All patients in the study were diagnosed with quiescent to mild active Crohn’s disease associated with chronic abdominal pain.
During the study, reductions in pain were seen within the first week of treatment and a statistically significant improvement from baseline abdominal pain scores were found at weeks four and eight. Arena also said the pain relief not only kicked in rapidly but lasted through the entire eight-week study with both doses that were tested.
Olorinab was also found to be safe and generally well tolerated in this study with no clinically significant changes in heart rate or blood pressure, no psychotropic effects, and no discontinuations due to adverse events.
“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,” stated Bruce Yacyshyn, MD, Professor Medicine in the Division of Digestive Diseases at the University of Cincinnati College of Medicine and Medical Director for Inpatient Gastroenterology at UC Health University Hospital. “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.”
Preston Klassen, MD, MHS, Chief Medical Offer of Arena, said, “The intent of this Phase 2a study of olorinab was to get directional information on the safety, tolerability and therapeutic potential 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. We look forward to providing additional detail on the development path forward during Arena’s R&D Day on October 4th.”
Analysts at Cantor Fitzgerald have described olorinab as an “underappreciated asset” in Arena’s pipeline with a profile that could position it favorably against other cannabinoid receptor modulators and say the new data “clearly establish olorinab as a viable drug worthy of advanced development.”
While Olorinab is just in the trial phase and seems to only be indicated for a very small patient population, it is worth watching to see if other companies follow suit with a non-opioid alternative to pain medication for various conditions and needs.