Eli Lily on Wednesday said it could halt development of solanezumab, a candidate for the treatment of Alzheimer’s disease, after the antibody didn’t slow the progression of the disease.
The failure of Solanezumab is a blow to efforts to treat Alzheimer’s disease in people who find themselves in the very early stages of the disease and not yet showing clinical symptoms.
The study involved over 1,000 seniors who had normal memory and considering functions, but showed signs of plaque in the brain that’s associated with Alzheimer’s disease.
Solanezumab did not remove or stop the buildup of atherosclerotic plaque, called amyloid, and did not slow cognitive decline in the participants who received the treatment.
“These data suggest that we may should be more aggressive in removing amyloid even at a really early stage in the disease,” said Dr Reisa Sperling, a neurologist at Brigham and Women’s Hospital and lead researcher.
Solanezumab is designed to focus on the amyloid protein that floats in the brain fluid. Lilly is developing two other Alzheimer’s drugs which might be in late-stage clinical trials, donanemab and remternetug. These antibodies goal the amyloid plaque that has built up in the brain and are intended to treat people with early signs of the disease.
Join CNBC’s Healthy Returns program on March 29 as we convene a virtual meeting of healthcare CEOs, scientists, investors, and innovators in healthcare to reflect on the progress made today in reinventing the future of medication. As well as, we could have an exclusive list of the best investment opportunities in biopharmaceuticals, medical technology and managed care. Discover more and register today: http://bit.ly/3DUNbRo
Lilly expects to release donanemab clinical trial data in the second quarter of this 12 months. The corporate plans to use to the Food and Drug Administration for approval of the treatment if these data are positive.
Lilly asked the FDA for accelerated approval of donanemab, but the agency rejected the company’s application in January. The agency told Lilly it needed to submit data on not less than 100 patients who had received treatment for 12 months.
Lilly said she did not have those data because donanemab rapidly clears the brain plaque in lots of patients.
“On account of the rate of plaque reduction we observed, many patients were in a position to discontinue the drug after only six months of treatment, leading to fewer patients receiving doses of donanemab for 12 months or more,” said Dr. Dan Skovronsky, Lilly’s Chief Scientific Officer, said analysts during an interview about the company’s earnings in February.
“We’re confident in the potential of donanemab as a latest drug for people with early signs of Alzheimer’s disease,” said Skovronsky.
The FDA approved Eisai and Biogen’s Leqembi early Alzheimer’s disease treatment on an accelerated basis in January. The businesses expect the agency to make a choice on full approval in July.
Medicare will only cover Alzheimer’s antibody drugs that receive accelerated approval for those participating in clinical trials. The senior public medical insurance program said it would offer more coverage once the FDA gives full approval.
Explanation: Solanezumab is designed to focus on the amyloid protein that floats in the cerebral fluid before being deposited in the brain as atherosclerotic plaques.