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FDA accepts protocol for new Traumakine trial
FDA accepts protocol for new Traumakine trial.
About this update from Faron Pharmaceuticals Oy
[{"type":"text","content":"\n \n \n RNS Number : 3588F\n Faron Pharmaceuticals Oy\n 09 March 2020\n \n \n \n \n Faron Pharmaceuticals Oy\n \n \n (\"Faron\" or the \"Company\")\n \n \n \n \n \n FDA accepts protocol for new Traumakine trial in ARDS \n \n \n \n \n \n \n \n \n \n Company announcement, 09 March 2020 at 9.00 AM (EET)\n \n \n \n \n \n \n \n Inside information\n \n \n \n \n \n \n \n TURKU - FINLAND \n \n - Faron Pharmaceuticals Oy (AIM: FARN, First North: FARON), the clinical stage biopharmaceutical company, today announces that the U.S. Food and Drug Administration (FDA) has accepted the proposed protocol design for the next Traumakine study in ARDS patients, following the Company's protocol submission announced on 6 February 2020. \n \n \n \n \n \n The trial protocol reflects the feedback and conclusions from the FDA that further studies with interferon-beta (IFN beta-1a) should exclude the use of concomitant glucocorticoids since they are likely to block the desired therapeutic effect of Traumakine and may have a potentially deleterious impact on patient survival. This harmful interaction has been previously evidenced both clinically in the INTEREST study, where concomitant glucocorticoids use was associated with increased mortality, and experimentally ex vivo using human lung tissue and pulmonary endothelial cells.\n \n \n \n \n \n Faron is planning to split the clinical development of Traumakine in ARDS into two steps, commencing with INTEGRITY, a pilot randomised and placebo controlled study with approximately 60 patients. The INTEGRITY data will then serve as final adjustment for adequate statistical powering and sample size justification for the pivotal CALIBER study, subjected for FDA review. The Company expects that the sample size of the CALIBER study will not exceed 200 patients based on the post hoc analysis of the INTEREST trial data. As previously announced, the Company envisages that future Traumakine trials (including INTEGRITY and CALIBER) are likely to be funded through a third party or parties.\n \n \n \n \n \n \n Dr. Markku Jalkanen, Faron's CEO, said:\n \n \"FDA's acceptance of our proposed study design and protocol is a significant step for the future development of Traumakine. Our learnings from previous trials in this development programme have enabled us t...