Cumberland previously received IND clearance from the FDA for several indications including Systemic Sclerosis and Duchenne Muscular Dystrophy. Phase II clinical studies in patients with those conditions are well underway.
"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," said A.J. Kazimi, Cumberland Pharmaceuticals Chief Executive Officer. "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."
About the new Phase II Clinical Trial
The FIGHTING FIBROSIS™ clinical trial is a multicenter, double-blind, placebo-controlled Phase II study in patients with IPF. The study will investigate the safety and efficacy of once daily oral ifetroban for 52 weeks. Subjects will be block randomized by background therapy (pirfenidone or nintedanib) and assigned to one of two treatment groups, ifetroban or placebo, at a dose of 250 mg daily. Approximately 128 subjects with IPF will be enrolled in the U.S. The primary objective is to improve lung function, as measured by the FVC in IPF patients on ifetroban compared to placebo over 52 weeks.
While FDA-approved antifibrotic therapies have shown efficacy to slow progression of the disease, there is no approved treatment which effectively halts disease progression and improves patients' symptoms. Therefore, an unmet need exists to identify additional treatments which add benefit and provide alternatives to existing therapies.
Cumberland is also sponsoring the FIGHT DMD™ trial, a multicenter, randomized, placebo-controlled Phase II study evaluating two doses of oral ifetroban for the treatment of the cardiomyopathy associated with Duchenne muscular dystrophy, a rare and fatal genetic disorder. The FDA awarded Cumberland $1 million in funding under its orphan products grants program to support this trial. This was the first DMD trial awarded such funding.
Cumberland recently completed a Phase II study investigating ifetroban in patients with aspirin-exacerbated respiratory disease (AERD), a rare and severe form of asthma. While the Phase II AERD study showed ifetroban improved patient symptoms, and significantly in some cases, there was not a statistically significant difference with the comparator arm of the study.
The Company plans to complete each of these sponsored studies, analyze data, announce top-line results, and then decide on the best development path for the registration of ifetroban, which has the potential to benefit many patients with orphan diseases that represent unmet medical needs.
Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of high-quality prescription brands to improve patient care. The Company develops, acquires, and commercializes brands for the hospital acute care, gastroenterology and rheumatology market segments. The Company's portfolio of FDA-approved brands includes:
For more information on Cumberland's approved products, including full prescribing information, please visit the individual product websites, links to which can be found on the Company's website www.cumberlandpharma.com.
Cumberland Emerging Technologies, Inc. is a joint initiative between Cumberland Pharmaceuticals Inc., Vanderbilt University, Launch Tennessee and WinHealth Pharma. The mission of CET is to bring biomedical technologies and products conceived at Vanderbilt and other regional research centers to the marketplace. CET helps manage the development and commercialization process for select projects and provides expertise on intellectual property, regulatory, manufacturing and marketing issues that are critical to successful new biomedical products. CET's Life Sciences Center, located in Nashville, Tennessee, provides laboratory space, equipment and infrastructure to early-stage life sciences companies.
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