Faron Pharmaceuticals Ltd (LON:FARN) is headed into a crucial and potentially transformational period with recruitment to its Phase III trial for its lead drug set for completion later this year.
A positive readout for Traumakine, used to treat acute respiratory distress syndrome caused by pneumonia, would pave the way for its launch in Europe and the US.
WATCH: Faron Pharmaceuticals boss upbeat as Phase III trial enters critical period
The company said Tuesday it would be allowed by America’s Food & Drug Administration to make a biologics licence application if the drug successfully navigates ongoing late-stage European and Japanese studies.
Traumakine is also being assessed for its potential to treat multi-organ failure and a Phase II trial has begun.
Clevegen, Faron’s cancer immunotherapy, is set to undergo preclinical toxicity studies.
An agreement has been inked with the University of Birmingham Medical School to begin a liver cancer clinical trial programme.
READ: Faron Pharma gets a boost as FDA says can use outside US trial data for Traumakine license application
"Our aim is to build Faron into a global business dedicated to addressing areas of significant unmet need, utilising the opportunities contained within our wholly owned pipeline of novel drug candidates,” said chief executive, Dr Markku Jalkanen.
The update was delivered alongside the drug developer’s financial results for the six months to June 30.
In common with most companies at this formative stage of their development, Faron was unprofitable; the operating loss was €7.2mln.
More importantly it has the cash to negotiate what promises to be a pivotal phase in its development with €10.3mln in the bank.
In late afternoon trading, Faron Pharma shares held steady at 717.5p.
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