Eli Lilly Halts Development of Solanezumab for Alzheimer’s Disease Due to Lack of Efficacy in Slowing Disease Progression

Intelligent Finance APP learned that Eli Lilly (LLY.US) announced on Wednesday that it would stop the development of its Alzheimer's disease treatment candidate drug solanezumab because the antibody failed to slow down the progression of the disease. It is understood that the failure of Solanezumab is a blow to the efforts to treat patients in the early stages of Alzheimer's disease who have not yet shown clinical symptoms.

Specifically, this study recruited more than 1,000 elderly individuals whose memory and cognitive functions were normal but showed signs of brain plaques associated with Alzheimer's disease. Solanezumab is an antibody that targets plaques floating in the brain. In addition, Eli Lilly and Company is also developing two other drugs for Alzheimer's disease, namely donanemab and remternetug, which are currently in the late stages of clinical trials.

These antibodies all target plaques deposited in the brain and are aimed at treating people with early symptoms. However, Solanezumab cannot clear or prevent the accumulation of plaques known as amyloid, nor can it slow down the cognitive decline of the participants receiving treatment.

Donanemab can rapidly clear brain plaques

Eli Lilly and Company is expected to release clinical trial data for donanemab in the second quarter of this year. If the data is positive, the company plans to request approval from the U.S. Food and Drug Administration (FDA) for treatment.

Previously, Eli Lilly had requested the FDA to expedite the approval of donanemab, but the agency rejected the request in January this year, stating that it needed data from at least 100 patients who had been treated for 12 months. In response, Eli Lilly stated that they did not have such data because donanemab could rapidly clear brain plaques in many patients.

Eli Lilly's Chief Scientific Officer, Dr. Dan Skovronsky, told analysts on a February earnings call this year: "Due to the rapid reduction in plaque, many patients can stop treatment after six months, leading to fewer patients receiving donanemab for 12 months or longer."

Skovronsky said, "We remain confident in the potential of donanemab as a new therapy for patients with early symptomatic Alzheimer's disease."

Notably, in January this year, the FDA granted accelerated approval to Eisai and Biogen's (BIIB.US) early Alzheimer's disease treatment drug Leqembi. These two companies anticipate that the agency will make a full approval decision in July.