Faron Pharmaceuticals has announced that its licensing partner Maruishi Pharmaceutical has reported positive results from its study of Traumakine for ARDS.
Faron said the open-label trial consisted of 12 patients with moderate ARDS and six patients with severe ARDS with an average APACHE II score of 31.6.
APACHE II is a measure of the severity of disease and risk of death in intensive care patients. An integer score of between 0 and 71 is calculated, and a higher score corresponds to more severe disease and a highter risk of death.
The company reported that Traumakine was safe and well-tolerated in all tested dosing groups, which were 2.5 mcg, 5.0 mcg and 10 mcg daily for six days.
Faron said the all-cause mortality rate at day-28 was 22.2% across all patients, compared to a typical mortality rate of 75% for patients with an average APACHE II score of 31.6, while the day-28 mortality rate across the two highest dosing cohorts – 5 mcg and 10 mcg – was 16.6%.
Below these two dosing levels there was no full drug effect, the firm said. “The trial results reported by Maruishi are extremely encouraging, particularly as the trial included very sick ARDS patients, yet still resulted in relatively low mortality rates,” said Faron CEO Dr Markku Jalkanen.