Sosei delays Alzheimer's trial after 'unexpected toxicology finding'

Japan’s Sosei (TSE: 4565) and licensing partner Allergan (Nasdaq: AGN) are suspending clinical development activities with HTL0018318 after a surprise toxicology result.

There will now be an investigation into the finding, which is of an unknown cause, and which was based on research being undertaken in non-human primates. The adverse finding has been reported to the US and Japanese regulators.

The decision will delay the start of planned Phase II studies in Alzheimer’s and dementia with Lewy bodies (DLB) patients by at least six months. This will result in a revenue impact next year, as Sosei will now likely not receive a major milestone payment from Allergan in 2019.