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(Sharecast News) - Faron Pharmaceuticals announced on Monday that the US Food and Drug Administration (FDA) has accepted its proposed protocol design for the next 'Traumakine' study in acute respiratory distress syndrome (ARDS) patients, following its protocol submission in February.
The AIM-traded firm said the protocol reflected the feedback and conclusions from the FDA that further studies with interferon-beta should exclude the use of concomitant glucocorticoids, since they were likely to block the desired therapeutic effect of Traumakine, and could have a "potentially deleterious" impact on patient survival.
It said the harmful interaction had 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.
Faron said it was planning to split the clinical development of Traumakine in ARDS into two steps, starting with 'INTEGRITY' - a pilot randomised and placebo controlled study with around 60 patients.
The INTEGRITY data would then serve as final adjustment for adequate statistical powering and sample size justification for the "pivotal" 'CALIBER' study, subject to FDA review.
It said it expected that the sample size of the CALIBER study would not be more than 200 patients, based on the post-hoc analysis of the INTEREST trial data.
As it had previously announced, Faron envisaged that future Traumakine trials, including INTEGRITY and CALIBER, were likely to be funded through a third party or parties.
"FDA's acceptance of our proposed study design and protocol is a significant step for the future development of Traumakine," said chief executive officer Markku Jalkanen.
"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.
"We look forward to providing further updates as our funding discussions with third parties progress," Dr Jalkanen added.
At 1023 GMT, shares in Faron Pharmaceuticals were down 9.24% at 270p.
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