Prana's PBT2 generally tolerated in Huntington's trial

Prana Biotechnology (ASX:PBT) has released results of a phase II trial of its PBT2 candidate in Huntington's disease, finding the drug to be generally well tolerated.

Results from the trial have been published in the journal Lancet Neurology.

The randomised, double-blind, placebo-controlled trial involved 109 adults with Huntington’s disease. Each were given daily doses of either 250 or 100 mg of PBT2 or a placebo.

During the trial, six serious adverse events occurred in five participants. These were acute coronary syndrome, major depression, pneumonia, suicide attempt, viral infection and a worsening of Huntington’s disease.

The investigators determined that all except the worsening of symptoms were unrelated to the drug. While 32 participants in the 250 mg group and 30 in the 100 mg group experienced at least one adverse event, so did 28 in the placebo group.

The treatment group did show signs of improvement in executive function, but did not show a statistically significant improvement in most cognition tests used for analysis.

The investigators concluded that the drug is generally well tolerated in Huntington’s patients, but that the potential benefit on executive function will need to be confirmed in a larger study.

Prana Executive Chairman Geoffrey Kempl said the company now plans an End of Phase 2 meeting with the US FDA as part of its commercialisation program for the drug.

“The Lancet publication supports our commitment to take the next steps in the commercial pathway towards developing PBT2 as a treatment for Huntington’s disease,” he said.

Prana Biotechnology (ASX:PBT) shares were trading unchanged at $0.185 as of around 1 pm on Wednesday