Positive results of preclinical-trial studies on the therapy’s pharmacology — the way it works — and toxicology paved the way for the trial, the company said.
PXS-5382A blocks an enzyme known as LOXL2 that is associated with the development of pulmonary fibrosis, or PF. Synairgen and Pharmaxis have been collaborating on the development of PXS-5382A and other LOXL2 inhibitors.
“The effect of this novel inhibitor across different model types is very exciting, with the latest supporting data suggesting that PXS-5382A can significantly reduce lung fibrosis and therefore has the potential to improve lung function in severely ill patients,” Richard Marsden, Synairgen’s CEO, said in a press release.
“These data build on the encouraging results seen to date and further support the rationale behind bringing this promising inhibitor to clinic,” he added.
Researchers believe LOXL2 contributes to fibrosis development by cross-linking with collagen — a main component of fibrotic tissue. Synairgen’s studies showed that PXS-5382A blocks LOXL2’s activity. In doing so, it reduced collagen cross-linking in fibrosis models, including an animal model of lung fibrosis.
“We believe PXS-5382A is a very valuable candidate, with potential applications in a number of fibrotic conditions, including lung, liver, cardiac and kidney fibrosis,” Marsden said.
The Phase 1 clinical trial is expected to run until mid-2018, the company said. Once Synairgen and Pharmaxis have the results in hand, they plan to license PXS-5382A to another pharmaceutical company for further development.
Marsden said PXS-5382A has already attracted significant interest from companies interested in developing anti-fibrotic drugs for several diseases.
“We look forward to progressing these discussions as PXS-5382A advances through” clinical trials, he said. “This outcome has been the result of a successful collaboration with Pharmaxis,” combining “their expertise in small molecule drug development and Synairgen’s expertise in translational research in lung diseases.”