Pharmaxis and Synairgen have revised their Lysyl Oxidase type 2 enzyme (LOXL2) program collaboration agreement, after obtaining positive results in preclinical studies and launching a Phase 1 clinical trial.
Strong evidence suggests that LOXL2 contributes to the formation of scar tissue (fibrosis), which can harden and irreparably damage the lungs. Based on this, both companies agreed in August 2015 to work together to develop a selective inhibitor of LOXL2 as a potential idiopathic pulmonary fibrosis (IPF) treatment.
Joint preclinical studies showed that blocking LOXL2 in a lab-grown IPF cell model and in in vivo models reduced scar tissue formation in a dose-dependent manner and improved lung function.These results suggest that LOXL2 inhibitors might alter IPF disease progression by slowing the buildup of scar tissue.
Under the revised agreement, Pharmaxis will be responsible for the program’s operations, including the ongoing Phase 1 trial testing PXS-5382, an oral LOXL2 inhibitor, in healthy volunteers in Australia. Researchers are examining the safety, tolerability, pharmacokinetics (how a drug affects an organism) and pharmacodynamics (how an organism affects a drug); it is expected to finish in the second half of 2018.
The agreement also entails a payment of £5 million (about $6.7 million) to Synairgen.
Synairgen will have no further financial obligations in the development of LOXL2 inhibitors, but will continue to provide technical support for the licensing process.
“Under the existing collaboration, Synairgen generated excellent data to support progression in the rare fibrotic lung disease idiopathic pulmonary fibrosis (IPF) and Pharmaxis has focused on the potentially larger indications of liver fibrosis (including non-alcoholic steatohepatitis), cardiac fibrosis and kidney fibrosis. As we draw nearer to an optimal point … it is more effective and should be more value enhancing to hand all control of the development to Pharmaxis,” Richard Marsden, chief executive officer of Synairgen, said in a press release.
Pharmaxis is developing another LOXL2 inhibitor, called PXS-5338, to possibly treat several fibrotic diseases. PXS-5338 is also now in Phase 1 trial.
Synairgen is involved in the development of an interferon-beta therapy candidate, SNG0010, to treat chronic obstructive pulmonary disease (COPD).
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