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Positive top-line results from the Japanese Phase II study of Traumakine for the treatment of ARDS
7 January 2016 • Author: Nicholas Jackson
Faron Pharmaceuticals Ltd has announced that its Japanese licensing partner Maruishi Pharmaceutical Co., Ltd. has obtained positive results from the Phase II Japanese study for Traumakine conducted by Maruishi in Japan. Traumakine is in development for the treatment of acute respiratory distress syndrome (“ARDS”).
Based on these results Maruishi is now planning the next pivotal clinical trial to be conducted in Japan. The following is an overview of the study results:
- The open-label trial (JapicCTI-142716) to study safety and initial efficacy of Traumakine in the Japanese population consisted of 12 patients with moderate ARDS and six patients with severe ARDS with an average APACHE II score of 31.6 (13-49), 18 patients in total.
- Traumakine (Maruishi code is MR11A8) was safe and well tolerated in all tested dosing groups (daily 2.5 mcg, 5.0 mcg and 10 mcg for six days).
- The all-cause mortality rate at Day 28, being the primary efficacy end point, was 22.2% across all patients (4/18). The typical mortality rate for patients with an average APACHE II score of 31.6, as published by Critical Care Medicine (1985; 13:818-829), is 75%.
- The Day 28 mortality rate across the two highest dosing cohorts (5 mcg and 10 mcg), below which dosing level there is no full drug effect, was 16.6%.
Dr Markku Jalkanen, CEO of Faron, said: ”Following the announcement of the first patient recruitment for our pivotal Phase III Pan-European INTEREST trial, we very much welcome the positive news of the Japanese Phase II study. 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. We are 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.”
The Phase II study (JapicCTI-142716) was conducted at 15 intensive care unit facilities in Japan, from February to December 2015. A total of 18 ARDS patients were recruited, 12 of whom had moderate ARDS and six with severe ARDS. There were three cohorts for Traumakine, low (2.5 mcg), medium (5 mcg) and high (10 mcg) doses and all cohorts enrolled a total of six patients. The efficacy primary end point was all-cause mortality at Day 28 and the results for each of the cohorts were 2/6 (33.3%), 0/6 (0%), and 2/6 (33.3%), respectively. The Day 28 mortality of patients, who received 5 mcg or higher of daily MR11A8, was 2/12 (16.7%) and, by severity, 1/9 (11.1%) in moderate and 1/3 (33.3%) in severe patients.
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