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). During the March 2016 quarter Boehringer provided a program update confirming the planned timing for the commencement of a phase 2 clinical trial as the first quarter of 2017. The commencement of a phase 2 trial triggers the payment of a development milestone to Pharmaxis of approximately A$25 million.
Pharmaxis Completes Recruitment of Pivotol Bronchitol Cystic Fibrosis Clinical Trial for U.S. Market
Pharmaceutical research company Pharmaxis today announced it has completed recruitment of its international clinical trial evaluating Bronchitol® (mannitol) in adults with cystic fibrosis. The results of the trial (CF303) are expected to be reported in the second quarter of 2017.
The Phase 3 trial is being conducted in accordance with the requirements of the US Food and Drug Administration (FDA) to gain approval for Bronchitol to treat cystic fibrosis (CF) in the United States in adult patients. Subject to a positive trial outcome, the Company will submit a response to the FDA and a decision on approval can be expected in 2018.
As guided by the FDA, the trial is a 26 week randomised, double-blind parallel group investigation of Bronchitol administered twice daily in patients aged 18 and over with cystic fibrosis to assess improvements in lung function, pulmonary exacerbations and safety. Subject to final randomisation of patients screened by the trial sites, the final enrollment is expected to reach 420 adult CF patients.
BIO 2016 - Shareholder Update
Pharmaxis CEO Gary Phillips recently attended the 2016 BIO International Convention in San Francisco from 6 – 9 June 2016. BIO is the biotech world’s largest meeting attended by almost 16,000 people from 76 countries. The BIO Business Forum hosted a record-breaking 35,700 partnering meetings with more than 3,400 companies participating. The drug discovery efforts at Pharmaxis are commercially driven and this is an important event for the Company to conduct market research amongst target customers, ie Big Pharma. Meetings confirmed that interest in Pharmaxis is growing.
The Company's most important objective was to connect with companies with whom Pharmaxis had previously discussed its LOXL2 anti fibrotic program - to keep them informed of progress and timelines. A second priority was to evaluate interest in the Pharmaxis neuro inflammation SSAO/MAOB program amongst companies that are looking for Alzheimer’s drugs - do they believe that the target has a place in treatment, what pre-clinical models would convince them of the potential value, what other neurology indications it might be appropriate for? The forum also provided the opportunity to discuss other aspects of the Pharmaxis pipeline.
The attached Shareholder Update summarises the Company’s participation at BIO.
In addition, Australia’s independent research publication Bioshares interviewed Gary Phillips both before and after the conference. The Bioshares articles may be read here: