CITRAMEL COMPLETES PHASE IIA CLINICAL TRIAL

Breathe Easy is pleased to announce has completed the Phase IIa clinical trial of its locally developed cystic fibrosis treatment drug, Citramel™. In this study, Citramel™ demonstrated excellent safety and tolerability in participants with cystic fibrosis.

We would like to thank the trial participants for their contribution to the programme to date. We also thank the principal investigators of the study in Auckland, Christchurch, Dunedin and Waikato, and their respective teams.

With the confirmation of safety and tolerability, Breathe Easy intends to commence in Q1 a dose escalation study to determine the maximum tolerated dose for Citramel™, prior to a potential future trial cystic fibrosis and/or bronchiectasis subjects.

Breathe Easy also intends to undertake further analysis of the effects of Citramel™ on the dissolution of sputum from those with cystic fibrosis and/or bronchiectasis. This analysis may require assistance and support from the cystic fibrosis and bronchiectasis community, as will any subsequent trials to investigate the impact of higher concentrations of Citramel™ on cystic fibrosis and/or bronchiectasis subjects if they occur. Please get in touch if you are able to assist.

Posted in Blog | Comments Off on CITRAMEL COMPLETES PHASE IIA CLINICAL TRIAL

Citramel phase IIa clinical trial commences in Christchurch and Auckland

Citramel, a locally developed therapy with potential to improve the lives of thousands worldwide living with cystic fibrosis is now being tested in a Phase IIa clinical trial in Christchurch and Auckland. This follows on from the completion of a Phase I trial of Citramel in healthy subjects which indicated that the treatment was well tolerated.

The Phase IIa clinical trial compares Citramel inhalation with a placebo inhalation, and all study participants will receive both therapies for 4 weeks each. The study takes 12-14 weeks to complete and involves 13 visits to the study site during that time. The regular assessments will include lung function tests, you will be required to provide blood and sputum samples, and your vital signs (blood pressure, pulse, temperature and weight) will be measured.

To be eligible for the trial, potential participants must meet all the study entry criteria and be able to attend all visits to the study site in Christchurch or Auckland. The main entry criteria for participants are:

  • Aged at least 16 years, with a confirmed diagnosis of cystic fibrosis
  • An FEV1 of 40-100% of predicted normal for age, gender and height
  • Other medications are on stable doses
  • No hospital admissions in the previous month
  • Pregnant and nursing women are excluded
  • Those with significant other diseases or conditions may not be suitable

Detailed information on this Phase IIa trial can be found on the ANZCTR website: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368708

Posted in Blog | Comments Off on Citramel phase IIa clinical trial commences in Christchurch and Auckland

Citramel trial completes successful Phase I

Citramel trial completes successful Phase I and kicks into
second gear for Phase IIa

A patient takes part in the first phase of Breathe Easy’s Citramel cystic fibrosis drug at the Christchurch Clinical Studies Trust.

Citramel, a locally developed therapy with potential to improve the lives of thousands 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 trials.

Phase I 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 IIa trial which will take place in Christchurch and Auckland, with leading respiratory physicians from both regions overseeing it.

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 this disease and from different treatment backgrounds, from around the country.”

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.

“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 IIa, with those results likely to be out later next year. If this 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 by contacting us

Posted in Blog | Comments Off on Citramel trial completes successful Phase I