CARE-CF (NCT03000348, NBTCS-02) is a randomized, double-blind, parallel group, and placebo-controlled study designed to investigate the optimal dose regimen, effectiveness, and safety of oral Lynovex in adult patients being treated for exacerbations in CF-associated lung disease. The objective is to assess Lynovex’s benefits as an adjunct therapy to standard of care (SoC), and six dose regimens will be tested.
The study, which is recruiting participants, will involve 120 adult patients in Europe and the United States, and will run throughout the winter exacerbation season. More information is available on its clinical trials.gov webpage.
Lynovex, an orphan drug candidate, works through a triple mode of action:
- Mucolytic — Disrupting the mucus in CF patients’ airways
- Antibacterial — Addressing current (such as Pseudomonas aeruginosa) and emerging pathogens
- Antibiofilm — Addressing mucus buildup within the airways
In the trial, patients will take Lynovex capsules for 14 days in combination with SoC for exacerbations. Criteria for participation include exacerbations caused by a Gram-negative bacterial infection; a forced expiratory volume in 1 second (FEV1; a measure of lung function) higher than 30%; and weighing more than 88 pounds.
“Dosing the first patients with Lynovex in the CARE-CF-1 study is a significant milestone for the business. This trial marks an important step in a product candidate which has shown significant potential to mitigate the effects of, and the symptoms experienced during, CF infectious exacerbations,” Deborah O’Neil, chief executive officer of NovaBiotics, said in a press release.
“These episodes can have a permanent impact on the respiratory function of CF patients and, with Lynovex in tablet and inhaled form, we are part of the fight to lift the life-limiting restrictions that CF places on people with the condition,” O’Neil added.
NovaBiotics reported positive results in 2015 from a Phase 2a clinical trial of the drug. In that study, 10 adult CF patients received increasing Lynovex doses over five weeks, along with SoC. Lynovex was found to enter the patients’ bronchial secretions, and data suggested it positively impacted a number of clinical parameters measured, including sputum bacterial load and viscosity.
The company is developing two formulations of the same active ingredient: the oral drug for CF exacerbations, and an inhaled one for chronic therapy. The inhaled formulation is likely to begin a proof-of-concept clinical trial this year.