US-based biotechnology firm Trevi Therapeutics has enrolled the first patient in its multi-centre, randomised, double-blind, placebo-controlled, parallel, three-arm study of Nalbuphine ER in hemodialysis patients with uremic pruritus.
The recently released Phase I trial data showed that Nalbuphine ER was well-tolerated in hemodialysis patients and established proof-of-concept for Nalbuphine ER in treating uremic pruritus.
Approximately 360 patients in the US and Europe will be enrolled in the trial, which is designed evaluate the safety and anti-pruritic efficacy of Nalbuphine ER tablets.
Trevi president and chief executive officer Jennifer Good said: "Approximately 40% of hemodialysis patients have moderate to severe pruritus that significantly impacts their quality of life.
"The initiation of this pivotal study of Nalbuphine ER is a significant step forward in the development of a potential therapeutic treatment option for these patients."
The company said that currently there are no approved therapies for the treatment of this condition.
The trial’s primary endpoint will measure the change from worst itch at baseline in patients with moderate to severe uremic pruritus, treated with two doses of Nalbuphine ER.
The trial also includes other secondary endpoints, such as patient perception of the burden of itch, quality of life effects of pruritus, and impact on sleep, anxiety and depression.
Trevi chief medical officer Thomas Sciascia said: "There has been a significant amount of research done over a number of years hypothesizing that the mu antagonist/kappa agonist mechanism could be a good treatment option for patients suffering from chronic pruritus."
The trial will include a titration period of two weeks, followed by a six week blinded period on a fixed dose of drug or placebo and a wash-out period.
The company said that at the end of the wash-out period, patients may be eligible to roll over into a six month open label extension study.
Trevi expects to announce topline data from the trial in the fourth quarter of 2015.