Traumakine is a medicinal therapy being developed by Faron Pharmaceuticals for the treatment of acute respiratory distress syndrome (ARDS). Until now, there has not been a therapy approved to treat ARDS, a life-threatening disorder with a high mortality rate.

On Sept. 4, 2017, Faron announced that the U.S. Food and Drug Administration (FDA) gave the company a green light to proceed with the next step of development for Traumakine by proposing it submit a biologics license application (BLA) for the medicine if current clinical trials show positive results. An early biologics license could shorten the time to approval.

How Traumakine works

Traumakine is a recombinant form of the cytokine interferon-beta (INF-beta). Cytokines are small proteins that are important for cell signaling.

The respiratory symptoms of ARDS develop when protein-rich fluid leaks through the cells that line the blood vessel wall, called endothelium, into the lungs. The leakiness is related to low levels of adenosine, a protein that helps prevent fluid from escaping through the endothelium. Traumakine helps stop the leaking by increasing adenosine levels.  It does so by interacting with CD73, a protein that helps control the amount of adenosine that cells produce.

Traumakine in clinical trials

A Phase 1/2 open-label trial (NCT00789685), completed in 2011, tested INF-beta in 47 patients with ARDS and acute lung injury (ALI) to determine whether the drug was safe and potentially effective. The results, published in The Lancet Respiratory Medicine in early 2014, showed that INF-beta was safe, well-tolerated, and reduced patients’ risk of death by 81 percent. The trial also established the ideal dose of drug needed to achieve effectiveness while maintaining safety

A Phase 3 double-blind, randomized, multinational trial (NCT02622724) called INTEREST began in November 2015 and is currently underway. INTEREST will compare INF-beta to placebo in a total of 300 patients with moderate-to-severe ARDS. INF-beta will be considered effective if it improves survival, or reduces the number of days on a ventilator, significantly more than placebo. The trial is expected to be completed by December 2018 and is still recruiting participants.

Additional information

Traumakine comes as a powder that is combined with water then injected into a vein.

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