Faron Pharmaceuticals Oy (LON:FARN, First North:FARON) said the US regulator has accepted the protocol design for a trial of Traumakine, a treatment for acute respiratory distress syndrome (ARDS).
The study set-up reflects feedback from the Food & Drug Administration and means that patients with the life-threatening condition won’t receive a class of steroids called glucocorticoids while being administered the Faron interferon-beta medication.
The new late phase assessment of Traumakine will be split into two.
The first strand, named INTEGRITY, will be a pilot randomised and placebo-controlled study of 60 patients.
The INTEGRITY data will then be fed into planning of the CALIBER trial in around 200 people with ARDS.
The company has said both clinical investigations will be funded outside the company.
Faron chief executive, Dr Markku Jalkanen, added: "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 to refocus our efforts on Traumakine, which we continue to believe holds great potential as a future treatment for ARDS, including flu or coronavirus infected people.”