Synairgen upbeat on recent LOXL2 inhibitor findings

Respiratory drug discovery and development company Synairgen announced on Wednesday that, following the successful completion of preclinical pharmacology and toxicology studies, a compound from its anti-fibrotic Lysyl Oxidase type 2 (LOXL2) inhibitor programme - PXS-5382A - was being prepared to commence Phase I clinical development.

The AIM-traded firm said PXS-5382A was being developed in partnership with ASX-listed Pharmaxis to target the fatal lung disease idiopathic pulmonary fibrosis (IPF) and other fibrotic conditions including non-alcoholic steatohepatitis (NASH), kidney fibrosis and heart fibrosis.

Its board said it would progress PXS-5382A through the Phase I trial, the results of which were expected by mid-2018.

After that, Synairgen and Pharmaxis planned to out-license PXS-5382A to a “suitable partner” to fully realise the commercial value of this compound given the potential size and number of indications it could address.

“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,” said Synairgen CEO Richard Marsden.

“These diseases represent areas of high unmet medical need and consequently present very substantial market opportunities.”

Marsden said the effect of the “novel inhibitor” across different model types was “very exciting”, with the latest supporting data suggesting that PXS-5382A could “significantly reduce” lung fibrosis and therefore had the potential to improve lung function in severely ill patients.

“These data build on the encouraging results seen to date and further support the rationale behind bringing this promising inhibitor to clinic.

“Based on PXS-5382A's potential across a number of disease areas and the promising data seen to date, we have received significant interest from companies looking to license the programme for multiple indications.

“We look forward to progressing these discussions as PXS-5382A advances through the clinic.”

Marsden said such an outcome had been the result of a successful collaboration with Pharmaxis, through the combination of their expertise in small molecule drug development and Synairgen's expertise in translational research in lung diseases.

Synairgen’s board described LOXL2 as a pro-fibrotic enzyme believed to play a significant role in the collagen cross-linking formation process in fibrotic diseases such as NASH, cardiac fibrosis, kidney fibrosis and IPF; all of which remained areas of high unmet need that could have “substantial potential”.

It said the LOXL2 inhibitor PXS-5382A is a “potent and selective” inhibitor of LOXL2 and had consistently been shown to “significantly reduce and inhibit” cross-linking formation in in vitro and in vivo models of lung, liver and cardiac fibrosis.

The findings had been the subject of presentations at numerous international scientific conferences, the board claimed, with more data set to be presented at similar upcoming events as the Phase I trial proceeds.

The company said it was continuing to analyse the data from the INEXAS trial, and also expected to make a further announcement regarding the potential of its inhaled interferon-beta drug (SNG0010) shortly.