CPIX News & Events

Cumberland Pharmaceuticals shared updated results from its Phase 2 FIGHT DMD trial evaluating ifetroban, a novel oral therapy for Duchenne muscular dystrophy heart disease, at the annual Parent Project Muscular Dystrophy conference in Orlando, Florida. The presentation highlighted key updates to the primary findings in the FIGHT DMD trial, reinforcing ifetroban's potential to address the leading cause of death in patients with DMD. The 12-month Phase 2 FIGHT DMD trial previously demonstrated that high-dose ifetroban treatment resulted in a significant 5.4% improvement in left ventricular ejection fraction compared to a control group composed of placebo-treated patients combined with propensity score-matched natural history patients. The study findings also included reductions in cardiac damage markers in the high-dose group. All patients who completed the 12-month study opted to continue in the open-label extension. New findings from the Phase 2 FIGHT DMD trial, supported by long-term safety data from the ongoing open-label extension, further characterize the cardioprotective effect exerted by ifetroban in DMD cardiomyopathy. Through 36 months of treatment across both the Phase 2 trial and the open-label extension, ifetroban maintained a favorable safety profile in DMD patients with no treatment-related serious adverse events or new safety concerns. Evaluation of novel blood biomarkers identified a 30% reduction in MYL3 and a 50% reduction in MYOD1, alongside a 2.4-fold increase in FGF16 and a 2.1-fold increase in TSPAN7 with ifetroban treatment compared with placebo. These confirmatory findings further support the potential therapeutic mechanisms for ifetroban in DMD cardiomyopathy.

Cumberland Pharmaceuticals and Vanderbilt Health announce data from a Phase 2a clinical trial of ifetroban to prevent metastasis in high-risk solid tumors. The study's primary safety endpoint was achieved, along with favorable trends in decreased metastasis recurrence and metastasis-free survival. A safe and effective medication that reduces distant metastatic recurrence could transform cancer management and improve the lives of millions of cancer survivors and their families. The randomized, double-blind, placebo-controlled Phase 2a trial evaluated the safety of ifetroban, an investigational thromboxane A2 receptor antagonist, in patients with solid tumors at high risk of early metastatic recurrence. Cancer types included breast, lung, pancreatic, soft tissue, bladder, and renal cancers. The study met its primary endpoint, demonstrating that ifetroban was safe and well-tolerated in this patient population. Rates for adverse events related to treatment were similar between placebo and ifetroban. No serious adverse events in either group were identified as being related to study treatment. Treatment discontinuation rates were not statistically different between placebo and ifetroban. Although primarily a safety study and intentionally not powered for efficacy, the study compared the percentage of patients with distant metastatic recurrence 12 months after completion of therapy in both groups (10 placebo-treated and 18 ifetroban-treated participants) as a prespecified secondary endpoint. While 50% of participants experienced distant metastatic recurrence in the placebo arm, only 17% of participants experienced distant metastatic recurrence in the ifetroban arm. Three deaths due to distant metastatic disease occurred in the placebo arm, and none occurred in the ifetroban arm.

Cumberland announced the launch of its Vibativ - telavancin - injection in China, following regulatory approval and a strategic partnership with SciClone Pharmaceuticals. The launch follows an agreement granting SciClone exclusive rights to register, promote and distribute telavancin, injection across China. The product's approval by China's National Medical Products Administration, or NMPA, enables SciClone to commercialize the product in one of the world's largest and fastest-growing pharmaceutical markets. Telavancin is a patented, FDA-approved injectable anti-infective that serves as a potentially life-saving treatment for patients with serious bacterial infections, including hospital-acquired and ventilator-associated pneumonia. Vibativ addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant.

Cumberland has entered into an agreement with an affiliate of Apotex, a Canadian based pharmaceutical company, to integrate their branded U.S. businesses. Under the terms of the agreement, Apotex will acquire Cumberland's line of branded pharmaceuticals for cash consideration of $100M, and create a platform aiming to deliver specialty medicines that improve the quality of patient care. The transaction is subject to authorization and approval by Cumberland's shareholders. Cumberland will retain its pipeline product candidates which it intends to focus on developing following the closing of the transaction. It will also retain its majority ownership position in Cumberland Emerging Technologies. In addition to its portfolio of FDA approved brands involved in the transaction with Apotex, Cumberland is developing ifetroban, a thromboxane antagonist through a series of programs designed to address unmet medical needs. The company has announced results in a Phase II clinical study of ifetroban in patients with cardiomyopathy associated with Duchenne muscular dystrophy. Interactions with the FDA are underway regarding the study results and remaining requirements for approval. The program has received Orphan Drug, Rare Pediatric Disease and more recently Fast Track designations from the FDA.