Enrollment complete in clinical trial of nalbuphine ER for IPF cough
CORAL testing therapy, to be marketed as Haduvio, in over 150 patients
Enrollment is now complete in a Phase 2b clinical trial, dubbed CORAL, that’s testing nalbuphine extended-release (ER) tablets — planned to be marketed as Haduvio — in people with idiopathic pulmonary fibrosis (IPF) who experience chronic cough.
That achievement was announced by Trevi Therapeutics, the U.S. company developing the therapy and sponsoring the study.
“The completion of enrollment in the Phase 2b CORAL trial is a significant milestone in the development of Haduvio for patients with idiopathic pulmonary fibrosis suffering from chronic cough,” James Cassella, chief development officer of Trevi, said in a company press release. “We look forward to reporting top-line data in the first half of this year.”
CORAL (NCT05964335) had aimed to enroll approximately 160 adults with IPF who have chronic cough. In the trial, patients are randomly assigned to take one of three doses of the therapy — 27, 54, or 108 mg — or a placebo, twice daily. The study’s main goal is to see how nalbuphine ER affects 24-hour cough frequency after six weeks of treatment.
Top-line data from Trevi’s Phase 2 trial expected by June
Trevi plans to use the results from CORAL to design future studies that could serve as the basis for applications seeking the approval of nalbuphine ER for people with IPF. Top-line data from the trial are expected by June.
“The results from this study will help us determine the optimal doses of Haduvio [nalbuphine ER] to move into our pivotal Phase 3 program,” Cassella said.
IPF is characterized by fibrosis, or scarring, in the lungs. This scarring interferes with the lungs’ ability to take in oxygen, and leads to symptoms that may include shortness of breath and cough.
“Chronic cough has a significant impact on IPF patients, and its persistent physical effects may worsen a patient’s overall health,” Cassella said. “Current off-label treatments and antifibrotics are often ineffective against chronic cough, leaving a substantial unmet need.”
The results from this study will help us determine the optimal doses of Haduvio [nalbuphine ER] to move into our pivotal Phase 3 program.
Nalbuphine is a compound designed to reduce coughing by modulating the activity of two proteins on nerves that control the reflex that triggers coughing. Specifically, the therapy acts by activating kappa receptors and blocking mu receptors. It exerts its effects on nerves in the brain and spinal cord, which comprise the central nervous system, as well as in those found throughout the body, or within the peripheral nervous system.
Trevi has announced Haduvio as the likely brand name for the oral ER formulation of nalbuphine, but the therapy has not been approved by any regulatory agency.
Data from a previous Phase 2a study called CANAL (NCT04030026) indicated that nalbuphine ER was significantly better than a placebo at reducing cough frequency among people with IPF.
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