Boehringer Ingelheim Program on Track
In May 2015 Boehringer acquired the Pharmaxis investigational drug PXS-4728A to develop initially as a treatment for non-alcoholic steatohepatitis (NASH). Boehringer has confirmed the planned timing for the commencement of a phase 2 clinical trial as the second quarter of 2017. The commencement of a phase 2 trial in NASH triggers the payment of a development milestone to Pharmaxis of approximately A$25 million.
In May 2017, Boehringer confirmed it would pursue a second indication for PXS-4728 in a separate phase 2 study, also commencing in 2017. Pharmaxis will receive
a milestone payment of €10m at the commencement of the trial in the second indication.
Latest news on NASH
A silent liver disease epidemic As nonalcoholic steatohepatitis, or NASH, stealthily becomes a leading cause of liver transplants, drug companies are racing to develop treatments. , Chemical & Engineering News, October 3, 2016
Pivotal Bronchitol Clinical Trial (CF303) Meets Primary Endpoint
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 (ASX: PXS) today released a recording of a video interview with Chief Executive Officer Gary Phillips discussing the results of the pivotal Bronchitol® cystic fibrosis clinical trial for the US market reported earlier today and an update on the Pharmaxis business.
The ten minute video interview can be accessed via the following link:
Pharmaxis Appoints Former Head of Global Research at Merck to Board of Directors
Pharmaxis has expanded its Board with a significant new appointment of internationally recognised executive Dr Kathleen Metters. Dr Metters has an impressive career spanning more than 25 years 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, known as MSD outside the United States and Canada) which included senior executive roles leading work in global research, discovery and preclinical sciences.
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. She is currently a senior advisor for Bridge Medicines where she is working to improve the translation and commercialisation of research in New York based academic institutions.
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.
Pharmaxis Chairman Malcolm McComas said, “The appointment of Dr Metters to the Pharmaxis Board follows a global search for a candidate who could contribute to the Pharmaxis business model of creating value through excellence in drug discovery and development. Her distinguished career in drug discovery inside a major multinational Pharma company and more recent role as a CEO of a smaller biotech company gives Dr Metters the experience and insight to make a significant contribution to Pharmaxis. We are delighted to welcome her to the Board at a time when we are making significant steps forward with our pipeline of anti-inflammatory and anti-fibrotic therapies and progressing our aim to building a globally competitive company.”