information: Clinical trial authorisation
Announcement: clinical trial authorization
Company: Faron Pharmaceuticals (Finland)
Product: Traumakine® - FP-1201 (human recombinant interferon-beta 1a)
- 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)
area: Lung diseases - Respiratory diseases - Rare diseases
- • On January 24, 2018, Faron Pharmaceuticals announced that the FDA has approved the Investigational New Drug (IND) Application for Traumakine® for the treatment of Acute Respiratory Distress Syndrome (ARDS), which is part of the regulatory process towards BLA submission.
- The FDA has already proposed that Faron can proceed directly to Biologics License Application (BLA) pending positive results from the two on-going Phase III trials (INTEREST in Europe and MR11A8-2 in Japan) and the IND forms part of this process towards BLA submission. Faron also continues to consider providing access to Traumakine in the US to ARDS patients under an expanded access program, which requires an IND. Top-line data from the INTERST study is due in the first half of 2018.
- Faron is also planning to conduct a small open label study in the US for pharmacological purposes and the IND will allow opening of clinical activities in the US. This first US study will target Traumakine (drug product FP-1201-lyo) in moderate and severe ARDS patients, especially with end organ (kidney and liver) failures.