Faron looks at compassionate use programme as INTEREST trial nears end

Clinical stage biopharmaceutical company Faron Pharmaceuticals updated the market on the INTEREST Phase III study treating patients with moderate to severe acute respiratory distress syndrome (ARDS) with its lead product Traumakine on Friday, following a meeting of the trial's independent data monitoring committee (IDMC) on 1 August.

The AIM-traded firm said that, at the “fifth and advanced” meeting, the committee recommended that the trial should continue as planned with no changes, consistent with the previous four recommendations.

Faron’s board said it anticipated that recruitment of the targeted 300 patients would complete during the fourth quarter of 2017.

“As the INTEREST Phase III study nears completion, Faron plans to initiate an expanded access program for Traumakine to start once the trial is closed to new patients,” the company’s board said in its statement.

“This will allow compassionate use of Traumakine in eligible named patients at European ICU hospitals, who may benefit from Traumakine treatment ahead of the product's potential regulatory approval.”

Faron described ARDS as a “severe orphan disease” with a reported mortality rate of approximately 30-45%, for which there was currently no approved pharmacological treatment.

It said ARDS is characterised by widespread capillary leakage and inflammation in the lungs, most often as a result of pneumonia, sepsis, or significant trauma with around 300,000 annual cases in Europe and the US.

“We are very pleased to receive the IDMC's recommendation that the INTEREST study should continue as planned,” said Faron’s chief executive officer Dr Markku Jalkanen.

“The trial is now moving into its final stages and we look forward to closing recruitment during the fourth quarter of 2017.”

Dr Jalkanen said that, given the “imminent completion”, and based on the potential benefits that Traumakine could offer as further supported by another successful safety review, the company planned to set up a compassionate use programme for named patients with the disease following closure of the trial.

“The aim of this programme is to provide continued access to Traumakine once the INTEREST trial sites close, until conclusion of the regulatory approval process.”

Faron’s board explained that the INTEREST trial is a Phase III double-blind, randomised, parallel-group comparison of efficacy and safety of Traumakine (FP-1201-lyo) and placebo in the treatment of patients with moderate to severe ARDS.

The study, designed to include up to 300 patients, was currently being conducted in 60 hospital intensive care units in Belgium, Finland, France, Germany, Italy, Spain and UK.

It said the primary efficacy endpoint in the INTEREST trial was the all-cause mortality rate at day 28, the only accepted primary end point for marketing approval by EMA.

The INTEREST trial protocol was targeting a 50% reduction in all cause mortality at day 28 between placebo and treatment arm, from 30% to 15%.