Faron Pharmaceuticals enjoys ARDS success in Japanese trials
There was new hope for patients that develop acute respiratory distress syndrome (ARDS) and investors in Finland-based Faron Pharmaceuticals on Thursday after positive results emerged from efficacy and safety trials of a drug to treat the condition.
Faron Pharmaceuticals Oy (DI)
Pharmaceuticals & Biotechnology
The AIM-listed biopharmaceutical company announced that its Japanese licensing partner, Maruishi Pharmaceutical, had obtained the positive results from its Phase II study for Traumakine.
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.
"We are very happy to learn that Maruishi is now planning the next pivotal clinical trial which will enable them to move towards filing of Traumakine marketing approval in Japan", he added.
The results came hot on the heels of Faron's announcement on 29 December that they had recruited their first patient in the Phase III clinical trial of Traumakine in Europe.