Amplia Therapeutics Limited announced new data showing the efficacy of its investigational focal adhesion kinase inhibitor, AMP945, in a preclinical model of idiopathic pulmonary fibrosis.Current pharmaceutical standards of care for idiopathic pulmonary fibrosis are either OFEV or Esbriet. Both of these drugs have significant side effect profiles which limit their utility and there is considerable effort underway to find more tolerable and effective treatments for this debilitating and deadly disease. In 2020, net sales of OFEV and Esbriet were respectively 2.5 billion Euro and 1.1 billion CHF.

New data from preclinical studies show that in the industry-standard bleomycin challenge mouse model of IPF, AMP945 had comparable activity to OFEV, the current market leader. The studies were performed by an independent Contract Research Organisation specialising in fibrosis disease models. Of note, in a study arm combining treatment with AMP945 and OFEV there was no detectable increase in efficacy suggesting that, in this model, the maximum effect had been reached for both AMP945 and OFEV.

The study was designed as a more demanding and meaningful treatment model as opposed to often used prevention models. Accordingly, mice were challenged with saline only (sham) or bleomycin and lung fibrosis was allowed to develop for 7 days. Mice which had been challenged with bleomycin were then randomised into four groups and treated orally with inactive drug delivery vehicle, AMP945, OFEV or AMP945 + OFEV for 14 days.

Following treatment, lung fibrosis was measured using the Ashcroft score which is a standardised numerical scale used to quantify the extent of lung fibrosis in histological samples. The figure below shows that AMP945 and OFEV reduce lung fibrosis to a statistically significant extent, compared to treatment with vehicle.