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.
Stopping scars before they form
Pharmaxis is collaborating on a potential new scar treatment for burns, keloids and Dupuytren contracture. Early stage research from a group including The University of Western Australia, Fiona Wood Foundation, Royal Perth Hospital Burns Unit and Pharmaxis has been presented at the prestigious American Chemical Society meeting in Philadelphia.
The team tested their molecules using a “Scar-in-a-jar” model, which mimics scar formation. In short, this technique involved culturing human fibroblasts from scar tissues in a petri dish. The cells overproduce and secrete collagen, as they would in a real injury. In the study, the researchers added LOX inhibitors to cultures from patients with Dupuytren’s, keloids and other scar tissue, and detected changes using two-photon microscopy combined with biochemical and immunohistochemical analyses.
According to Swaminathan Iyer, Ph.D. from The University of Western Australia, “The preliminary data strongly suggest that lysyl oxidase inhibition alters the collagen architecture and restores it to the normal architecture found in the skin.”