The study, conducted in collaboration between NovaBiotics, a clinical-stage biotechnology company focused on the design and development of first-in-class anti-infectives for difficult-to-treat, medically unmet diseases, and the Aberdeen Royal Infirmary/University of Aberdeen’s Prof Graham Devereux showed activity of the drug within the CF sputum physiological environment, including its capacity to kill the emerging CF pathogen Mycobacterium abscessus.
A total of 23 CF adults were included in the study. The team of researchers measured the number of bacteria that were present in the samples of patients’ sputum before and 24 hours after exposure to Lynovex. This measurement was done with and without antibiotics frequently used to treat CF lung infections. The researchers also measured the viscosity of the sputum samples after the Lynovex treatment.
Results showed that Lynovex was able to reduce the levels of sputum bacteria a few hours after exposure, outperforming ciprofloxacin and tobramycin in its capacity to kill the sputum bacteria. However, the efficacy was even higher with the antibiotics combined with Lynovex. These findings indicate that Lynovex can be used concomitantly with common CF antibiotics in order to increase the effectiveness of the treatment.
In order to determine whether Lynovex had a direct antimicrobial effect on M. abscessus and in other bacteria usually found in CF sputum samples, patients infected with M. abscessus bacteria were isolated. For this subgroup of CF patients, Lynovex efficacy was assessed separately.
Results showed that the clinical isolates and one type strain of M abscessus tested were all sensitive to the antibiotic effects of Lynovex. Results also showed that Lynovex improved the antibacterial effect of antibiotics usually used as treatment for this pathogen. M. abscessus is a bacterium/complex of bacteria in CF and is considered a clinically challenging infection. Although only a very small number of M. abscesses were tested in this first study, the team has gained clear evidence on what to base larger tests of Lynovex on as a potential candidate in the treatment regime against Mycobacterial infections in CF.
Prof Graham Devereux, lead clinical investigator, commented: “In this laboratory study, we investigated whether Lynovex is able to kill the bacteria living in their own environment, namely the sputum to which they are adapted to live in. The effects of Lynovex on sputum bacteria, sputum viscosity and Mycobacterium abscessus are very promising. Further work is required to see if Lynovex works when given to people with CF.”
Dr Deborah O’Neil, NovaBiotics CEO said: “This study’s findings are the next essential step in Lynovex’s journey towards being a new therapy option for CF. This exciting drug candidate simply will not work unless its pharmacologic effects — against bacteria and mucus — are retained within CF sputum. We have now confirmed this with the data reported in our EBioMedicine publication”. She goes on to say that: “The M. abscessus data are very encouraging and timely and we look forward to investigating this further as a matter of priority.”