Scientists from University College London Hospitals (UCLH) completed a Phase II clinical trial for Faron Pharmaceuticals Ltd’s Traumakine, which demonstrated a significant reduction in mortality as a result of acute respiratory distress syndrome (ARDS), according to UCLH researchers.
The trial demonstrated an 81% reduction in mortality in ARDS patients, with a mortality of only 8.1% in patients treated with Traumakine, compared to the 32.2% mortality seen in the control group of ARDS patients, according to the study, which was published in The Lancet Respiratory Medicine.
The trial was conducted in eight intensive care units around the UK. It also found that other measured parameters, including length of mechanical ventilation needed, length of ICU stay, and support of vital functions also benefited from the Traumakine treatment.
Acute lung injury (ALI) and ARDS are major causes of death in intensive care units. Approximately 300-400,000 people suffer from ARDS in Western countries each year and the mortality rate remains high, around 35-45%, despite modern day care, according to UCLH.
Major causes of ARDS include direct lung injury such as lung infection (pneumonia), aspiration pneumonia or indirect injuries such as severe sepsis, major multiple trauma or pancreatitis.
Currently there is no effective drug treatment for ARDS, and patients tend to be treated with mechanical ventilation and optimization and support of vital functions, according to UCLH.
“Pulmonary vascular leakage occurs early in ALI/ARDS, and mortality remains high. An effective pharmacotherapy is desperately needed,” said Geoff Bellingan, medical director at University College London Hospitals.
“Traumakine has been shown to reduce capillary leak and we were very happy to see this translate into a benefit in ARDS patients as predicted. The drug promotes the formation of a local anti-inflammatory molecule and improves the amount of oxygen entering the blood stream from the air,” he added.
Faron Pharmaceuticals (Turku, Finland) has been granted orphan drug status for Traumakine (FP-1201-lyo) for the treatment of ALI/ARDS by the European Commission and European Medicines Agency (EMA). The company is waiting for EMA advice to start phase III studies.
In addition to its high rate of mortality, ARDS is also a major economic burden to hospitals and health care budgets. HCLU estimated that due to a long ICU and hospital stay, the cost of every saved life from ARDS is approximately $70,000. With a new efficient pharmacotherapy, hospital stays are likely to become shorter and the costs will likely diminish significantly.