Ifetroban cleared to be tested in IPF patients in Phase 2 clinical trial
Recruitment expected soon for study at more than 20 medical centers in US
Cumberland Pharmaceuticals is launching a Phase 2 clinical trial to assess the safety and efficacy of its investigational therapy, ifetroban, in treating patients with idiopathic pulmonary fibrosis (IPF).
The announcement follows the U.S. Food and Drug Administration (FDA) clearance of the company’s investigational new drug (IND) application — a formal request companies submit to regulatory agencies asking permission to start testing an investigational therapy in human trials.
The Phase 2 trial, called FIGHTING FIBROSIS (NCT05571059), is designed to enroll around 128 patients, ages 40-80, in more than 20 medical centers across the U.S. Recruitment is expected to start soon.
This trial represents the newest program in Cumberland’s ifetroban pipeline, with previous INDs cleared by the FDA and Phase 2 trials underway for other indications, including systemic sclerosis and Duchenne muscular dystrophy.
“We are pleased that the FDA has cleared this new clinical program as we work to develop new medicines for the future — especially those that address unmet medical needs,” A.J. Kazimi, Cumberland’s CEO, said in a company press release.
New therapies needed to provide alternatives to existing treatments
IPF is characterized by progressive inflammation and fibrosis (scarring) in lung tissue, making it hard for patients to breathe. Over time, such scarring can lead patients to experience shortness of breath and difficulty with daily activities, such as getting dressed or moving around.
Despite current antifibrotic therapies’ efficacy in slowing disease progression, there is not yet an approved treatment that can effectively stop IPF progression and ease patients’ symptoms. As such, there is a pressing need to identify new therapies that can add benefit and provide alternatives to existing treatments.
Ifetroban is a potent and selective thromboxane-prostanoid receptor antagonist. Thromboxane is a substance produced by platelets that promotes the formation of blood clots and blood vessel constriction, or narrowing. It has been implicated in many cardiovascular conditions, ranging from heart attack to stroke.
Ifetroban can block thromboxane-prostanoid receptors on different cell types, including platelets and airway muscle cells. In addition to its antiplatelet effects, ifetroban has been found to have antifibrotic properties, with previous preclinical studies demonstrating its ability to prevent and increase the resolution of lung fibrosis.
“Given the exciting preclinical data demonstrating ifetroban can prevent lung fibrosis, we are very excited to advance directly to a Phase II study for IPF patients,” Kazimi said.
Study’s objective is to assess lung function improvements
FIGHTING FIBROSIS will investigate the safety, tolerability, and efficacy of ifetroban in a group of IPF patients. Participants will be block randomized by their background therapy — Esbriet (pirfenidone) or Ofev (nintedanib) — and assigned into one of two groups, receiving either an oral capsule containing 250 mg of ifetroban, or a placebo, once daily for 52 weeks.
The study’s primary objective is to assess lung function improvement by measuring changes in forced vital capacity (FVC) — the total amount of air a person can forcibly exhale after a deep breath — in the group of patients treated with ifetroban and placebo over the course of one year.
Other outcomes, such as the effects of treatment on patients’ quality of life, fatigue, shortness of breath, cough symptoms, and occurrence of side effects will also be evaluated. The trial is estimated to start this month and to be completed in April 2027.
Cumberland plans to complete all its sponsored studies testing ifetroban across a range of different diseases, analyze the data, and announce top-line results before deciding the best development route to follow for its registration.