What is Lynovex and what does it do?

Lynovex is an experimental treatment for cystic fibrosis (CF) being developed to be used alongside current standard of care CF medicines. Evidence so far suggests Lynovex works in a few ways; by killing the bacteria associated with cystic fibrosis respiratory infections and breaking down the biofilms these pathogens often colonise the airway of CF patients. Lynovex also makes these bacteria more sensitive to the antibiotics currently used as standard in CF therapy.

Why is it being developed in 2 forms?

Lynovex in tablet (hard gel capsule) form is intended as a high dose, short term treatment for CF exacerbations to be used alongside antibiotic and other therapy over the 14 days of medical intervention for an exacerbation event.  Lynovex is also be developed as a low dose inhaled medicine (in dry powder inhaler form) for long term maintenance of symptoms in stable CF patients.

What clinical trials are underway and/or planned and where will they take place?

The CARE-CF-1 (NBTCS-02) study recently concluded with positive top line data reported here: Lynovex.co.uk. This trial assessed the safety and efficacy of Lynovex tablets in CF exacerbations in adult patients with gram negative respiratory infection,  predicted FEV1>30% and >40kg in weight. See Clinical Studies for further details. The next clinical trial planned for Lynovex tablets (CARE-CF-2) will likely be initiated in 2019. A first clinical trial of inhaled Lynovex in adult patients is planned for 2019. Studies in adolescents and children will follow as soon as possible following confirmation of safety, tolerability and efficacy in adult patients.

Will I be eligible as an adult or child with CF for NovaBiotics studies?

The eligibility criteria for the CF-CARE-1 study can be found on the Clinical Studies page. This study is for adults only, but subsequent clinical trials for the tablet and inhaled form of Lynovex are planned in adolescents and children.

Could Lynovex be taken with the other treatments I am on for my CF?

Lynovex is intended to be an adjunct therapy; to be used alongside existing CF treatments, not to replace them.

How long will it be before Lynovex is approved as a drug?

The launch dates for the various forms of Lynovex depend on the success of the current and upcoming clinical studies and whether the data and outcomes from these trials are deemed as sufficient for the regulatory authorities the US and Europe and also the payers (NICE and SMC in the UK for e.g.). We anticipate however that, subject to continued successful development, the tablet form could be available to patients as an approved medicine within the next 2-3 years.

Can I access Lynovex before its approved

CF patients who have participated in Lynovex clinical trials may be eligible for continued access to Lynovex before it is an approved medicine. 

What is the difference between Lynovex and other medicines that contain cysteamine?

Lynovex should not be confused with other cysteamine-containing medication. The dose, dose frequency and length of treatment for cysteamine based medicines is very different for CF patients (e.g. those with cystinosis). The safety and tolerability of cysteamine in CF patients has only been confirmed in adult patients and over short periods of treatment (14 days) and at specific doses.