Pharmaxis recently presented encouraging interim results regarding a single ascending dose stage phase I clinical trial that is evaluating its experimental therapy PXS4728A. The pharmaceutical company expects to offer the Semicarbazide-Sensitive Amine Oxidase/Vascular Adhesion Protein-1 (SSAO/VAP-1) inhibitor as treatment for lung conditions such as chronic obstructive pulmonary disease (COPD), among other indications.
Within the single ascending dose stage study conducted by Pharmaxis, which included 48 healthy volunteers, there were no reports of safety concerns regarding patients who were administered PXS4728A. The participants were treated with either single doses of 1mg PXS4728A, 20mg PXS4728A or placebo. The trial confirmed the oral bioavailability of PXS4728A, as well as its ability to produce long-lasting blockage of the SSAO/VAP-1 enzyme, following the single dose.
“The successful completion of this first part of this Phase 1 study has confirmed the excellent preclinical profile of PXS4728A in healthy subjects and we now look forward to completing the trial and further discussions with Boehringer Ingelheim,” stated Gary Phillips, the CEO of Pharmaxis, in a press release, as he announced that data from the phase 1 trial will be featured at the 50th International Liver Congress, taking place between April 22 and 26, in Vienna, Austria.
Pharmaxis continues to advance its pre-clinical development program for PXS4728A and will now proceed with 24 participants with multiple ascending doses of the treatment. Each of the three groups will be treated with active or placebo doses every day for 14 days, and researchers will evaluate three different dosages of PXS4728A.
In addition to COPD, the highly selective small molecule inhibitor of SSAO is also expected to become a therapeutic option for other respiratory conditions and for Non-Alcoholic Steatohepatitis (NASH). Pharmaxis is also waiting for a decision from pharmaceutical company Boehringer Ingelheim, which has signed an Option and Asset Purchase Agreement for PXS4728A and can execute it until May 15.