Neuren Pharmaceuticals shares fell hard after disappointing results from a trial of its brain injury drug “trofinetide”.
A short time ago, the ASX-listed shares were down almost 30% to $0.074.
The clinical trial conducted with the US Army couldn’t find a difference, using key measures, between the drug and a placebo.
Neuren says a common challenge is the high degree of variability in the characteristics of injuries and patient populations.
The 260 patients enrolled in the trial included a higher than expected proportion who were severely injured.
Those with sustained severe injuries to the chest and other parts of the body are less likely to respond positively to a drug targeting brain injury.
Further detailed analysis of the trial data is underway to help define the optimum patient population, dose levels, duration of treatment and other measures.
Neuren and the US Army are discussing another trial.
Larry Glass, Neuren’s chief science officer, says the results from the trial support the use of considerably higher doses.
“After further analysis, we will determine with our US Army colleagues the best way forward for trofinetide in brain injury,” Glass says.
Dr Kenneth Bertram, of the US Army Medical Research and Materiel Command, says there’s an urgent need for solutions for traumatic brain injury.
“We are continuing to collaborate with Neuren on further analysis of the trial data,” he says. “The advances in the use of biomarkers that have been made during this trial will be an important tool for selecting and characterizing study populations in potential future clinical trials.”
Trofinetide, which inhibits inflammation and helps synaptic function, is a synthetic drug derived from a growth factor produced by brain cells.