Vasopharm GmbH announces positive data from clinical trials in traumatic brain injury

pharmafile | July 12, 2022 | News story | Manufacturing and Production  

Vasopharm GmbH has announced the results of significantly reduced brain microdialyse lactate levels in the Phase II (NOSTRA) and Phase III clinical trials of Ronopterin (formerly VAS203) for the treatment of traumatic brain injury (TBI).

These analyses expand on the improved clinical outcome, reduced aggressiveness of underlying treatment, and reduced brain microdialysate glutamate levels in patients with moderate and severe TBI, with early infusion of Ronopterin after TBI. 

Lactate is an important marker of underlying energetic impairment and impaired mitochondrial oxygen use. It is tightly linked to glutamate, which activates neurons as part of our normal brain function. Any excessive release of glutamate from cells damaged can induce further cell damage from glutamate-mediated excessive activation of neurons and astrocytes.

With early infusion of under 12 hours, Ronopterin significantly decreased brain microdialysate lactate levels, with a lower proportion of lactate levels.

Dr Stefan Wolf, Department of Neurosurgery Charité Berlin, Germany said: “As part of our bedside monitoring we closely follow any increases in lactate levels to identify signs of energetic impairment following TBI. This is important to initiate appropriate counter measures to prevent evolving structural and functional damage from impaired perfusion or insufficient oxygenation. A reduction in lactate is a very important sign of protection from secondary brain injury and preserved energetic stability. The combination of reduced lactate and glutamate levels suggests that lactate reflects glutamate-driven lactate production. This profile of biochemical neuroprotection suggests that iNOS inhibition with Ronopterin is paramount for us to consider in our treatment concept.” 

Professor John Stover, CMO of vasopharm added: “We are very excited to see that Ronopterin aimed at improving the neurologic outcome in TBI patients significantly reduces lactate levels under clinical conditions during the early vulnerable phase. To date, this has only been shown in vitro with acetamidine based iNOS inhibitors and in patients in need of barbiturates, a very aggressive treatment option to reduce otherwise uncontrollably increased intracranial pressure. The combined decrease in glutamate and lactate guides our decision making for the use of Ronopterin and forms a strong basis for us to expand our Clinical development plan for Ronopterin.”

Lina Adams

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