German biotech Adrenomed reports that its first-in-class antibody drug adrecizumab was well-tolerated by septic shock patients and met its primary goal in a phase II trial.
The company says it will release more detailed trial data in a peer-reviewed paper later in the year, but states that patients given adrecizumab, as opposed to placebo, had a lower risk for death from all causes.
“For the first time, we have seen a positive effect on early death in septic shock,” said Pierre-François Laterre, Head of the medical-surgical intensive care unit at Saint Luc University Hospital at the Université Catholique de Louvain, Brussels. “The data support adrecizumab being an effective therapeutic agent with an innovative mode of action which may improve survival of patients in the early stage of septic shock.”
Septic shock is a life-threatening consequence of sepsis, which occurs when the body’s immune system overreacts to infection. During septic shock blood pressure drops and the blood vessel walls become more permeable allowing fluid to leak into the surrounding tissues and cause congestion and bleeding, as well as organ failure. Currently, treatment largely involves giving fluid replacement therapy and antibiotics to target the infection.
When in the bloodstream, the hormone adrenomedullin stabilizes blood vessel walls. However, it can result in low blood pressure and worsening of septic shock when collected in tissues. Adrecizumab binds to adrenomedullin and directs more of the hormone into the bloodstream, which helps combat the symptoms of septic shock.
Adrenomed’s phase II trial included 301 patients from Belgium, France, Germany and The Netherlands with early stage septic shock. All the patients were given usual care and then half were given adrecizumab and half placebo. The primary endpoint of the study was demonstrating that the drug was safe and well tolerated in the treatment group, which was achieved. While the company did not release specific data on how this was measured, they said the results were consistent with those seen in earlier phase I trials. Risk for death from all causes was also lower in the treatment versus the placebo group.
Commenting on future development potential for adrecizumab, Jens Schneider-Mergener, CEO of Adrenomed, explained that the company was currently in discussions with the regulatory authorities and partners to decide how best to develop the drug in the future. He added that the company believes adrecizumab has the potential to treat other conditions involving leakage of fluid from the blood vessels such as acute heart failure.
Adrenomed has competition to bring a new treatment for septic shock to market. French biotech Inotrem is also working on a treatment for this life threatening condition. Its peptide drug targets the excessive immune reaction seen in these patients and is also being tested at phase II.
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