Date: 2016-01-07
Type of information: Results
phase: 2
Announcement: results
Company: Faron Pharmaceuticals (Finland) Maruishi Pharmaceutical (Japan)
Product: Traumakine® - FP-1201 (human recombinant interferon-beta 1a)
Action
mechanism: protein. FP-1201 is a human recombinant interferon-beta 1a. In acute lung injury (ALI) and acute respiratory distress syndrome (ARDS), the predominant patho-physiological result is increased vascular leakage, which has been shown to be due to the lack of adenosine, an end product of AMP degradation by 5’-nucleotidase (CD73). Adenosine acts to enhance endothelial barrier function via adenosine receptor activation. Therefore, any biological substance, which acts to increase adenosine level, will reduce vascular leakage and be of benefit in ALI/ARDS patients. Such substances are type I interferons, and especially the interferon-beta (IFN-beta). IFN-beta has been shown to up-regulate 5’-nucleotidase (also known as a CD73 molecule and expressed abundantly by normal endothelial cells) and prevent ALI in animal models (Kiss et al. (2007) Eur. J. Immunol. 37:3334).
Disease: acute respiratory distress syndrome (ARDS)
Therapeutic area: Lung diseases - Respiratory diseases - Rare diseases
Country: Japan
Trial
details: 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.
Latest
news: * On January 7, 2016, Faron Pharmaceuticals announced that its Japanese licensing partner Maruishi Pharmaceutical 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 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%.
