OrphoMed has initiated a Phase II response-adaptive clinical study of ORP-101 for the treatment of irritable bowel syndrome with diarrhoea (IBS-D).
The PREVAIL trial will assess the efficacy and safety of ORP-101 in around 320 patients with IBS-D. Patients are currently being enrolled.
A peripherally acting buprenorphine dimer, ORP-101 has already completed the Phase I study. The candidate received US FDA Fast Track designation in 2018.
The Principal Investigator of the PREVAIL trial Dr Anthony Lembo said: “ORP-101 has the potential to become an important therapy for the treatment of IBS-D. It could have a significant impact on patients’ health and quality of life.”
In the trial, the subjects will be administered with one of two different doses of ORP-101 tablets or placebo for 12 weeks.
The primary endpoint of the study is to identify the percentage of composite responders (participants who met the daily response criteria) based on improvements from baseline in daily worst abdominal pain and daily stool consistency scores.
Secondary endpoints include the percentage of participants who are responders in IBS global symptom, IBS adequate relief, daily abdominal discomfort and number of bowel movements per day, among others.
The ORP-101 study also features two pre-defined interim analyses to be conducted by a third party in the second half of this year. These analyses will determine the dose-response and patient allocation using response-adaptive randomisation and stopping accrual early for sufficient efficacy or futility.
The Topline results are expected in the first half of next year.