Australian biotech Prana Biotechnology ($PRAN) said an Imagine extension trial on the safety of a PBT2 neurodegenerative disease candidate did not identify any concerns, raising hopes that the company will lift a Partial Clinical Hold in the U.S. and head on to Phase III trials related to orphan status for Huntington's disease.
The news follows a release in April in which Prana Biotechnology said the European Medicines Agency's Committee for Orphan Medicinal Products has adopted a positive opinion recommending designation of PBT2 for the treatment of Huntington's disease.
But in March last year, the same drug failed to meet the primary endpoint goal of reducing amyloid beta in a Phase II test aimed at showing that it could trigger a chemical balancing act in the brains of Alzheimer's victims at a prodromal or early stage of development.
Other drugs, notably Eli Lilly's ($LLY) solanezumab and Janssen/Pfizer's ($PFE) bapineuzumab, have clinically reduced levels of amyloid beta in the brains of patients without significantly altering the course of the disease.
But the second lease on life for the candidate will see more work if possible, the company said in a press release.
"The safety data will form part of the package presented to the FDA as part of our goal to remove the Partial Clinical Hold on PBT2 in the U.S.," the company said.
"Prana will continue to work with the U.S. Food and Drug Administration and other agencies to initiate a Phase III trial for PBT2 to treat Huntington disease. PBT2 for the treatment of Huntington disease was recently granted Orphan designation in Europe and was granted Orphan designation in the U.S. in 2014."
The Imagine trial used a 250-milligram dose of PBT2 over a two-year period and allowed all 40 participants who completed the original 12-month period to receive PBT2 for a further 12 months.
Prana is listed on the Australian Stock Exchange, where it rose 3.33% to 0.155 Australian cents a share and the Nasdaq where it last traded at $1.17 a share.
- here's the Prana release