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FDA fast tracks IBS-D drug candidate
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Biopharmaceutical company OrphoMed announced that the FDA has granted Fast Track status to speed development of its drug candidate for diarrhea-predominant irritable bowel syndrome.
ORP-101, a buprenorphine dimer therapeutic, is a peripherally active partial mu opioid receptor agonist and K opioid receptor antagonist designed to ease colonic hypersensitivity stemming from intestinal hyperalgesia and motility dysfunction in IBS-D, according to a press release.
The company said that animal studies have shown the agent suppresses hyperalgesic signals — both in general and specific to the colon — without penetrating the central nervous system or constricting the sphincter of Oddi, which could lead to acute pancreatitis.
“Over 28 million individuals are impacted by IBS-D, a chronic, debilitating condition with limited treatment options,” Gary Phillips, MD, OrphoMed’s president and CEO, said in the press release. “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.”
The company noted it fully owns the proprietary agent with no downstream royalties or associated milestone payments, and raised $39 million in Series A financing in May 2017, which it will use to fund phase 2 development of ORP-101.
Disclosures: Phillips is employed by OrphoMed.