The two created PXS-5382A as a treatment for idiopathic pulmonary fibrosis (IPF) and other fibrotic diseases.
Preclinical-trial studies have shown PXS-5382A to be safe and effective. The companies expect to start the Phase 1 trial in the fourth quarter of 2017, with the first results expected by mid-2018.
PXS-5382A inhibits LOXL2, an enzyme involved in collagen fiber cross-linking, a process involved in fibrosis, or tissue scarring.
“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,” Richard Marsden, CEO of Synairgen, said in a press release. “These diseases represent areas of high unmet medical need and consequently present very substantial market opportunities.”
Studies in the lab and in animal models of lung, liver, and cardiac fibrosis have shown that PXS-5382A can reduce collagen. Researchers plan to present the studies’ findings at international scientific meetings.
“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,” Marsden said. “These data build on the encouraging results seen to date and further support the rationale behind bringing this promising inhibitor to clinic [clinical trials.”
After wrapping up the Phase 1 trials, Synairgen and Pharmaxis plan to license the drug to another pharmaceutical company. The hope is that this arrangement leads to it being used against a number of fibrotic diseases.
“We have received significant interest [on PXS-5382A] from companies looking to license the program for multiple indications,” Marsden said. “We look forward to progressing these discussions as PXS-5382A advances through the clinic.”
Synairgen is also developing an inhaled formulation of its interferon-beta therapy candidate SNG0010. It will be used to prevent and treat flare-ups of asthma and chronic obstructive pulmonary disease (COPD) caused by the common cold virus. Researchers are evaluating it in asthma patients in the Phase 2 INEXAS trial (NCT02491684).