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In the Alzheimer’s market, wins can quickly turn into losses, and losses can quickly turn into wins. Even the experts have lessons to learn. Getting the balance right has been a challenge for Cognition Therapeutics.
in Mid-term research project “Shine”The company’s sigma-2 agonist Alzheimer’s disease drug failed to live up to investor expectations. 43% drop When Cognition publishes its results, it’s usually a sign of failure.
Yet Cognition’s leaders considered the study a success. What happened?
Cognition Chief Executive Lisa Ricciardi said it’s harder for smaller companies to prove science, while larger companies tend to make their data look more appealing to interest investors.
“The clinical trials are proven,” Ricciardi said. “Other companies might be filtering[the data]but when Eisai or Biogen or Lilly stand on stage and present their data, people don’t have those concerns.”
The study included 153 adults with mild to moderate Alzheimer’s disease, whose cognitive decline was measured over a 182-day period on a scale called ADAS-Cog 11. Patients who received the drug, called CT1812, experienced 39% less cognitive decline than those who received a placebo. That’s how Cognition executives characterized the results, but investors had a different story to tell.
From their perspective, the placebo group dropped about 2.7 points on the scale, while patients taking CT1812 dropped 1.66 points, making the difference in cognition between the placebo and the drug just over 1 point, not a statistically significant change. And the company was a victim of its previous success, with the full results not reaching the same heights, as an interim announcement in November 2023 showed a 3-point difference in the first 24 patients.
But Dr. Anthony Caggiano, Cognition’s chief medical officer and head of research and development, said he was not aware of any side effects from Eisai or Biogen’s Lukembi or any of the other drugs. Eli Lilly’s XanlaThey were formerly known as lecanemab and donanemab, respectively.
“I think the scale here is good. Lecanemab and donanemab Over an 18-month period, we saw slowdowns of 25% and 30%, respectively,” Caggiano said.
Ricciardi said what makes the study appear less successful is the difference in how much patients in the placebo group improved later in the study, after interim results came in. Looking at graphs showing the progress of the study, she feels the results have been misinterpreted.
A graph from the Shine study showed that patients taking CT1812 saw their symptoms worsen 39% slower over time.
Used with permission from Cognition Therapeutics
“People listen briefly.”
Part of the problem, Ricciardi said, is a disconnect between what’s happening in research and what people want to hear.
“People aren’t going to listen right away, and this will require an explanation,” Ricciardi said, “but people will read the headline in the press release before the data is out, and that will cause a certain level of movement in the market, and it will become a self-fulfilling prophecy.”
Cognition is not alone in confusion over its recent studies — Neurocrine Inc.’s high-profile schizophrenia drug was touted as a success until growing competition led investors to sell off — showing that it’s not just the study’s headline figures that matter.
And because it’s a small company, smaller studies are subject to greater scrutiny, Caggiano said.
“We’re in a unique position to get these small proof-of-concept studies out to the whole world,” Caggiano said. “You know, Pfizer, Lilly and Merck aren’t telling anyone about these studies. We don’t have 1,200 molecules in development. We have one.”
and, Alzheimer’s Market The changes will add another level of instability, Ricciardi said.
“Everybody wants to get a piece of this good, growing market,” she says. “Everybody says, ‘Wow, I wish I had this drug when I needed it.’ Nobody thinks they’re immune to the effects of this drug. That’s part of why people are interested in developing these programs.”
Cognition has also taken CT1812 into Phase 2 trials as a treatment for Lewy body dementia, early Alzheimer’s disease and macular degeneration, so the drug’s story doesn’t end here and the company doesn’t intend to stop its progress due to mixed responses to the Shine trial.
