Investor Centre

Pharmaceutical research company Pharmaxis (ASX: PXS) today announced its recently completed international Phase 3 trial of Bronchitol® (mannitol) in adults with cystic fibrosis (CF) met its primary endpoint. 

• The study recruited adult CF patients with all grades of disease that were already on the best standard of care.
• The study demonstrated the superiority of Bronchitol versus the comparator on the primary endpoint (FEV₁ change from baseline over 26 week treatment period), with an effect of 54 ml (p=0.020), corresponding to a 2.2% relative change (p=0.025).
• The improvement in lung function was less than that seen in the adult CF population in previously reported phase 3 studies.
• No statistically significant differences between treatment groups in secondary endpoints were recorded, although a trend was observed in favour of Bronchitol for another lung function parameter (FVC).
• Bronchitol had a good safety profile with similar rates of adverse events seen compared to control.
• FDA resubmission is expected in 2018.

Pharmaceutical research company Pharmaxis today announced it has appointed Dr Kathleen Metters to the Board of Directors. Dr Metters has more than 25 years of experience in the discovery and development of novel therapies for the treatment of serious diseases.

Dr Metters spent 9 years as a senior executive with Merck & Co. (Merck Sharp & Dohme (MSD) outside the United States and Canada) which included a 4 year period as senior vice president and head of Worldwide Basic Research. That was followed by an appointment to design and establish External Discovery and Preclinical Sciences, created to expand Merck’s scientific network to the greater research community in academia, biotechnology, and government; building partnerships in life sciences, medicine, engineering, and information technology.

After leaving Merck in 2011 Dr Metters was appointed President and Chief Executive Officer for Lycera Corp., a biopharmaceutical company pioneering innovative approaches to novel oral medicines for treatment of autoimmune diseases and cancer. Under her leadership, Lycera developed a robust pipeline of proprietary and partnered immune modulator programs which formed the basis, in June 2015, of an exclusive global collaboration with Celgene Corporation.

Dr Metters will serve as a Non Executive Director on the Pharmaxis Board – joining current members Malcolm McComas, Simon Buckingham, Will Delaat and Gary Phillips.