Alzheimer’s drugs are expensive to test and unlikely to succeed, but they are also hard to kill.
More than two years after gantenerumab failed decisively in treating early-stage Alzheimer’s, Roche is mapping out an attempted comeback through a new, pivotal Phase III program that puts them back into the late-stage pipeline with their second therapy.
Investigators stubbornly vowed back at an international Alzheimer’s conference in 2015 that if you amped up the dosage of the amyloid beta antibody it would be possible to track a real treatment effect for Alzheimer’s, improving cognition and function. And now Roche partner MorphoSys, which contributed its platform tech in discovering the drug, says the pharma giant is going for it — again.
The German biotech says that its contacts at Roche are planning to launch two Phase III studies in mild to prodromal patients sometime later in the year, sticking to a group of patients who are just beginning to demonstrate symptoms of the memory-wasting ailment.
Roche never gave up on gantenerumab. Roche neuroscience development chief Paulo Fontoura tells me they’ve been using two extended studies to see if they can safely use a much, much higher dose needed to have an impact on the disease without stirring up dangerous levels of ARIA-E, or brain swelling.
“We wanted to find out if 4- or 5-fold (higher doses) would be successful,” Fontoura tells me, while controlling any cases of ARIA-E. And all indications,he adds, is that they are on the right track.
Nothing has worked in Alzheimer’s R&D over the last 14 years, and gantenerumab looked like it would join a list of the most prominent drugs in the field to wash out of a big Phase III. But researchers have also been emboldened by better diagnostics to select patients as well as by the early data from Biogen’s aducanumab program which has shown glimmers of efficacy. Eli Lilly only recently wrapped its last pivotal shot at solanezumab, its third straight failure.
Merck has also contributed to the drumbeat of failures, recently conceding defeat in the most advanced study of a BACE drug that tried to move upstream in the disease process, preventing the production of toxic levels of amyloid beta. And Lundbeck flopped with its three Phase III studies of their 5-HT6 antagonist idalopirdine, leaving Axovant as the last company to test that symptomatic approach in a pivotal study.
Why the dedication? There are no drugs that can modify the progression of Alzheimer’s and a big demand for any new symptomatic therapies that can slow the impact of the disease, leaving the field wide open for a blockbuster introduction. And with every setback, researchers insist that the same drugs could work under different circumstances.
Now Roche will soon have two pivotal programs for Alzheimer’s back in the clinic, with gantenerumab running alongside crenezumab.
“This is great news for MorphoSys. We are delighted by the strong commitment to gantenerumab as a potential new therapy for Alzheimer’s disease”, commented Marlies Sproll, the chief scientific officer of MorphoSys AG. “The HuCAL-derived antibody gantenerumab has properties that we believe make it a promising candidate to treat Alzheimer’s disease, and we look forward to learning more about these new Phase III trials.”
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