NovaBiotics Ltd has announced that its oral therapy for cystic fibrosis (CF), Lynovex ®, has met the study objectives of the CARE CF 1 clinical trial.
CARE CF 1 assessed the effects of two weeks of Lynovex treatment as an adjunct to standard of care therapy (SOCT) in CF, compared to placebo plus SOCT. This trial was designed to determine whether the inclusion of Lynovex capsules alongside SOCT lessened the clinical impact of exacerbations in adults with CF, as measured by symptom severity and levels of bacteria and inflammatory mediators in sputum and blood.
CARE CF 1 was a 6-arm study with the primary objectives of determining the optimal dose and regimen of Lynovex in patients with exacerbations of CF-associated lung disease and to further evaluate the safety and tolerability of Lynovex in exacerbating CF patients.
The initial efficacy outcomes measured in CARE CF 1 were the reduction in the number of bacteria in sputum, improvement in patient reported outcome scores of CF respiratory symptom severity and improvement in lung function (FEV1) following two weeks of treatment. The same dosing regime also resulted in a clinical and statistically significant reduction in blood white cell count after two weeks when compared with placebo.
These Lynovex specific improvements were mirrored by changes in health-related questionnaire scores, sputum levels of inflammatory mediators and a 4% increase in lung function after two weeks of treatment. The sputum of patients taking Lynovex also contained less bacteria (per mL of sputum) than sputum from patients who received only placebo plus their SOCT antibiotic treatment.
The coordinating investigator of CARE CF 1, Professor Graham Devereux said: “This trial suggests that people with CF who are exacerbating, feel and do better if Lynovex is added to their usual treatments. These clinical effects are supported by the finding that Lynovex significantly reduces the blood white cell count indicating reduced inflammation in the lungs. Potentially, if Lynovex is used for each exacerbation, it might be possible to slow the rate of lung damage and maintain health for longer.”
Dr Deborah O’Neil, CEO of NovaBiotics, commented: “There are currently no other exacerbation-specific treatment options in terms of interventions in CF. These results add validation to our previous work and the potential of Lynovex as a new class of therapy in CF. We look forward to receipt and analysis of the full data set from CARE CF 1 and to building from this the platform to progress into the registration phase of development of oral Lynovex as soon as we are able to”.