Citramel, a locally developed therapy with potential to improve the lives of thousands worldwide living with cystic fibrosis, has started the next phase of clinical trials in New Zealand.
Phase 1 trials of Citramel on healthy subjects in Christchurch has been successfully completed with findings indicating the treatment was well tolerated and safe. The company behind the therapy, Breathe Easy, has now commenced its Phase IIa trial initially in Christchurch and expanding to a second trial site in Auckland. The trial will be overseen by respiratory physicians from both regions.
This is the first trial for a therapy into subjects with cystic fibrosis 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, and is expected to improve the reliability data package produced.
“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 this disease and from different treatment backgrounds, from around the country.”
Breathe Easy’s CEO, Andrea Miller, says it’s been a long road to get to this stage, but it’s coming together now more rapidly.
“This time last year we were head down in capital raising mode, with trials just a distant vision. Now, 12 months later we’re heading into Phase IIa, with those results likely to be out later next year. If this Phase IIa is as successful as we hope, then we should have multiple options to fund bigger trials and include another country.”
Families around New Zealand interested in taking part in these trials can find more information on the Breathe Easy website: www.breatheeasytherapeutics.com.
The Directors have chosen to open a second site to speed patient recruitment and reduce the risk that insufficient patients within the trial criteria can be recruited for this rare disease. Having multiple sites independent of each other also improves the reliability data package produced.
To fund the additional trial site and the continuation of trials, the company plans to raise a further $1,000,000 through a new round of capital raising with oversubscriptions up to $1,500,000 in aggregate.
The offer will be underwritten to a minimum of $500,000, which has allowed for trials to proceed. For further information please contact Lachlan Nixon here.