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Faron's stock freefalls by 80% after key drug failure

Published on 09/05/18 at 10:09am

Faron Pharmaceuticals has seen its share price plummet by more than 80% after it emerged that its recombinant human interferon beta-1a drug traumakine failed to meet its primary endpoints in the treatment of acute respiratory distress syndrome (ARDS).

While there were no safety concerns raised by repeated use of the drug, traumakine comprehensively failed to improve on ventilator-free days – with a median of 10 days for traumakine patients and 8.5 for those taking placebo – and all-cause mortality rates, which at day 28 stood at 26.4% for traumakine and 23% for placebo, and 32.6% versus 31.6% at day 90.  

ARDS is a condition under which the lungs can’t provide enough oxygen to the body’s vital organs due to fluid build-up, and is normally caused by pneumonia, sepsis or trauma to the area. Affecting around 200,000 in the US and 170,000 in Europe, it is associated with a mortality rate of around a 30-45%, with no pharmacological treatment currently available.

The results are surprising, particularly considering the data released from a Phase 1/2 study of the drug which showed an 81% reduction in mortality. The Finnish firm’s Chief Executive Dr Markku Jalkanen noted that the study could have been swayed by an “unusually low mortality rate observed in the placebo arm.”

“We are incredibly disappointed and surprised by these results,” Dr Jalkanen said. “We need to further analyse the data in order to understand how this study differs from our previous positive results with ARDS patients, both in terms of Traumakine's efficacy, and in the unusually low mortality rate observed in the placebo arm.”

Matt Fellows

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