OrphoMed's IBS-D Candidate ORP-101 Receives Fast Track Designation

In June of 2017, OrphoMed announced that they had closed a $39 Million series A round to accelerate development of their lead candidate, ORP-101, IBS-D. On 4/25/18 they announced that the FDA has granted Fast Track designation for the Company's lead candidate ORP-101 for the treatment of irritable bowel syndrome with diarrhea (IBS-D).

Over 28 million individuals are impacted by IBS-D, a chronic, debilitating condition with limited treatment options," said Gary Phillips, M.D., OrphoMed's President and Chief Executive Officer. "Fast Track designation recognizes the urgent need for new therapies to treat patients with IBS-D. Our goal is to continue to advance ORP-101 into Phase 2 by the end of 2018."

ORP-101 is a metabolically stable, peripherally active partial agonist of the μ opioid receptor and antagonist of the κ opioid receptor that is designed to mitigate colonic hypersensitivity due to intestinal hyperalgesia and associated motility dysfunction in IBS-D. In multiple clinically relevant animal models ORP-101 has repeatedly been shown to suppress general and colon-specific hyperalgesic signals without CNS penetration and without constriction of the sphincter of Oddi, which could cause acute pancreatitis. ORP-101 is wholly owned by OrphoMed.