Roche and AC Immune’s Alzheimer’s drug on right track

New data from Roche’s Genentech unit suggests that a phase 3 trial of Alzheimer’s drug crenezumab is on the right track, at an optimum dose for patients in early stages of the disease.

The news provided a welcome piece of good news in Alzheimer’s R&D, following the failure of Eli Lilly’s solanezumab in early stage disease late last month.

Data from a dosing study suggest that a higher 60mg/kg dose in patients with prodromal-to-mild Alzheimer’s will improve outcomes, said the biotech that discovered crenezumab, AC Immune.

This dose was selected by Genentech for the phase 3 CREAD trial, which started recruiting patients in Q1 this year.

Genentech has developed a drug-disease progression model to simulate the phase 3 clinical trial and estimate the likelihood of achieving relative reduction in disease progression in patients treated with different doses of crenezumab, in different patient populations.

The model adequately described patients’ decline in a cognition test and a five-point scale in mild to moderate Alzheimer’s patients, treated with crenezumab in phase 2 studies.

The clinical trial simulations using the drug-disease model predict a meaningful response of crenezumab in patients with mild AD at a dose of 60mg/kg IV every 4 weeks, as measured by the ADAS-Cog 12 test and the CDR-SB scale.

Professor Andrea Pfeifer, CEO of AC Immune, said: “We are impressed by the drug-disease model, as well as the safety data of the phase 1b study which further support the higher dose of crenezumab in the phase 3 trial targeting prodromal-to-mild Alzheimer patients.”

AC Immune discovered crenezumab and out-licensed the drug to Genentech in 2006.

Crenezumab is a fully humanised IgG4 monoclonal antibody that binds all forms of misfolded Abeta proteins, but especially to Abeta oligomers, to prevent and break up Abeta aggregation and promote Abeta disaggregation.

Abeta plaques are found in the brains of patients with Alzheimer’s and are thought to cause the neurological damage that leads to the disease.

AC Immune’s share price spiked on the NASDAQ almost 30% after the news was announced, although prices fell back to around $12.60.

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