Local cystic fibrosis therapy trial kicks into second gear

Media Release

7 December, 2015

Local cystic fibrosis therapy trial kicks into second gear after a successful Phase 1

- Breathe Easy recruiting for CF subjects in Christchurch and Auckland

- Trial widens to include Auckland physicians and site

A locally developed therapy with potential to improve the lives ofthousands worldwide living with cystic fibrosis has been given the green light to move into the next phase of clinical trials in New Zealand, following completion of the first stage of trialing Citramel.

Phase 1 trials of Citramel on healthy subjects in Christchurch indicated that the treatment was well tolerated and safe. The company behind the therapy, Breathe Easy has just announced a wider Phase 11a trial which will include subjects from the Auckland region and involves leading respiratory physicians overseeing the trial.

It is the first early stage trial for a cystic fibrosis therapy in New Zealand, and is unique in that the therapy itself was developed here.

Chairman of Breathe Easy’s Scientific Advisory Board, Dr Paul Tan, says running dual sites presents significant advantages for the trial timeline.

“Conducting trials in Auckland and Christchurch simultaneously enables us to complete this second phase faster. We are now recruiting subjects in varying stages of severity of thisdisease and from different treatment backgrounds, from around the country.”

Dr Tan has conducted clinical trials in a range of countries, including New Zealand, and says the absence of adverse effects to date and a reasonable chance of a positive outcome are important factors for the successful development of this new treatment.

“New Zealand is a great place to carry out early clinical trials. We have excellent respiratory physicians here who are important for the safety and quality of the trials, as is a responsive cystic fibrosis community wanting to take part. We’re in the early stages of recruitment and the interest received so far is heartening.”

Breathe Easy CEO, Andrea Miller, says it’s been a long road to get to this stage, but it’s coming together now more rapidly.

“To think that this time last year we were head down in fundraising mode, with trials just a distant vision. Now, 12 months later we’re heading into Phase 11a, with those results likely to be out later next year. The challenge for us will be after that. If this is as successful as we hope, that next phase will require bigger trials and include another country. The required budget and size of that task will be another step up, but we’ve got this far, so we’ll continue to take it one bite at a time.”

Families around New Zealand interested in taking part in these trials can find more information on the Breathe Easy website www.breatheeasytherapeutics.com.

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