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(Alliance News) - Faron Pharmaceuticals Oy on Monday said the US Food & Drug Administration has accepted the proposed protocol design for the next Traumakine study in acute respiratory distress syndrome patients.
The clinical stage biopharmaceutical company said it is planning to split the clinical development of Traumakine into two steps, commencing with Integrity, a pilot randomised and placebo controlled study with 60 patients.
The data from Integrity study will then serve as final adjustment for adequate statistical powering and sample size justification for the pivotal Caliber study, Faron said, subjected for FDA review. The AIM-listed company said it expects that the sample size of the Caliber study will not exceed 200 patients.
"FDA's acceptance of our proposed study design and protocol is a significant step for the future development of Traumakine," said Chief Executive Markku Jalkanen.
Faron shares were trading 1.2% lower in London on Monday at 294.00 pence each.
By Evelina Grecenko; evelinagrecenko@alliancenews.com
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