Eli Lilly & Co. is terminating another Alzheimer's study of solanezumab, as the fallout from November 2016's disappointing phase 3 data continues.
November's poor clinical trial results led the company to stop development of the monoclonal antibody for Alzheimer's patients with mild dementia. Upon further analysis, another trial of patients with an even earlier stage version of the disease is being canceled too, Eli Lilly officials said during its fourth-quarter earnings call.
The study of patients with the prodromal, or very early stage version, of the disease was scheduled to conclude in 2021 and enroll 2,450 patients. But the distinction between prodromal and mild Alzheimer's is not as significant as many believe, according to Anthony Ware, senior vice president of product development, who said "a great deal of overlap" exists between the two populations.
Jan Lundberg, president of Lilly Research Laboratories, believes it is too early to determine if the failure of the solanezumab trial signals that the prevailing theory that amyloid proteins play a central role in the disease is incorrect. "We need to wait for even more powerful agents and the next in turn are the oral BACE inhibitors, which are more likely I think to have an even stronger effect on the amyloid beta in the brain," he said.
Eli Lilly has three such Alzheimer's candidates in its Alzheimer's pipeline, including one in phase 3. BACE inhibitors attempt to hinder amyloid development by targeting the oral beta secretase cleaving enzyme.
Although numerous efforts to develop an Alzheimer's drug have failed, the financial payoff awaiting whoever succeeds has kept R&D efforts alive throughout the industry.
Eli Lilly is closely following Merck & Co. Inc.'s phase 3 BACE inhibitor, which is due to report trial results later in 2017. "If Merck has a positive signal of any sort, I think we'd feel good about that in terms of BACE inhibitors as a target. If there's no signal, I think we'll have to do some thinking," Eli Lilly CEO David Ricks said during the call.
Company presentation slides show that Eli Lilly has seven Alzheimer's candidates in its pipeline, including solanezumab. While the drug is no longer being tested for the mild Alzheimer's indication, the company still believes it could be useful against so-called preclinical Alzheimer's. A large trial of older patients who may be at risk of memory loss concludes in October 2020, according to ClinicalTrials.Gov. The preclinical study targets patients with evidence of amyloid plaque buildup in their brains who have not experienced any of the cognitive decline symptoms associated with Alzheimer's.
Eli Lilly reported adjusted sales of $5.76 billion and adjusted operating expenses of $3.24 billion.
"Top-line sales came in slightly above our estimates," but "higher than expected operating costs were a drag on the bottom line," Leerink equity analyst Seamus Fernandez said in a Jan. 31 note. Cowen's Steve Scala concurred in his analyst note, also on Jan. 31. He had projected sales of $5.51 billion and expenses of $2.94 billion.
GAAP EPS guidance was reduced to a range of between $2.69 and $2.79 from $3.51 to $3.61 due to the planned $960 million acquisition of Cambridge, Mass.-based CoLucid Pharmaceuticals Inc.
Company officials said CoLudic's late-stage migraine candidate complement's Eli Lilly's own research in the field and could be labeled for use in patients with cardiovascular risk factors, unlike the existing migraine drugs on the market.