Press Release: Tough decision for Roche following mixed Phase II Trial results for Alzheimer’s drug

• Roche faces difficult decision over entering Alzheimer’s disease (AD) drug crenezumab for Phase III clinical trials.
• ‘The company should be encouraged by the drug’s demonstrated efficacy in mild AD patients, as any agent with a modest effect in AD can potentially achieve blockbuster returns,’ says analyst. 

LONDON, UK (GlobalData), 24 July 2014 – Following mixed results from crenezumab’s Phase II studies in mild-to-moderate Alzheimer’s disease (AD), Roche faces a difficult decision over entering the drug for Phase III clinical trials, says an analyst with research and consulting firm GlobalData.

Kyle S. Nicholson, PharmD, GlobalData’s Analyst covering Neurology, states that amyloid-beta-clearing antibody crenezumab, developed by AC Immune and Roche group member Genentech, failed to meet coprimary endpoints in the study group. However, the companies disclosed that the drug achieved statistical significance in both the functional and cognitive domains in patients with mild AD.

Genentech and AC Immune believe that these results are strengthened by the responses observed in a smaller biomarker study, and will delay any decision on crenezumab’s advancement into Phase III trials until further analysis of the results of the two midstage studies.

Nicholson says: “The combination of crenezumab’s disease-modifying mechanism of action and safety profile is promising, and the drug would become the fourth agent of its class in Phase III trials if Roche decides to proceed.

“Other monoclonal antibodies (mAbs) from Eli Lilly, Johnson & Johnson and Pfizer have missed the mark in late-stage trials and proven costly. A Phase III study for crenezumab could be decisive for active immunotherapies in symptomatic AD, as its failure in this stage could rule out the entire drug class.”

While Roche considers the next step for crenezumab, it will continue to work with its partner, MorphoSys, and the National Institutes of Health on a Phase III trial for its lead mAb candidate, gantenerumab.

Nicholson continues: “Similar to crenezumab, gantenerumab targets the amyloid-beta peptide and shows good central nervous system penetration. However, gantenerumab’s clinical potential might be hindered by dose-limiting side effects, such as inflammation and edema.

“Overall, crenezumab’s observed safety profile in Phase II trials suggests that Roche may be able to adjust its dosing and achieve improved results in Phase III. The company should be encouraged by the drug’s demonstrated efficacy in mild AD patients, as any agent with a modest effect in AD can potentially achieve blockbuster returns,” the analyst concludes.

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– Comments provided by Kyle S. Nicholson, PharmD, GlobalData’s Analyst covering Neurology.

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