The failure of Cognition Therapeutics’ Alzheimer’s disease candidate CT1812 in the SHINE trial earlier this year may have rubbed off some of the drug’s luster, but today’s win in the SHIMMER study should give the oral sigma-2 antagonist back its glow.
The phase 2 SHIMMER trial enrolled 130 patients with dementia with Lewy bodies who received either a 100-mg or a 300-mg dose of CT1812 or placebo for six months. The study met its primary endpoint of safety and tolerability, Cognition said in a Dec. 18 release.
“DLB patients treated with CT1812 for six months experienced improvement in behavioral, functional, cognitive and movement measures compared to placebo,” the biotech added. “Importantly, there was an 82% slowing in the neuropsychiatric inventory with particularly strong reduction in anxiety, hallucinations and delusions in the CT1812 treated arms.”
Patients in the CT1812 arms demonstrated a slowing of decline across all three cognitive measures, with the company highlighting that fluctuations in attention declined by 91%. The biotech didn’t drill further into the data but said detailed findings would be presented at the International Lewy Body Dementia Conference in January.
“These topline results exceeded our expectations and support the broad utility of CT1812 across neurodegenerative disorders,” Cognition Chief Medical Officer and head of R&D Anthony Caggiano, M.D., Ph.D., said in the release.
“Analysis of CT1812’s activity in DLB will continue as additional data become available,” Caggiano added. “We look forward to reporting these findings at future medical meetings and reviewing them with the FDA in an end-of-phase 2 meeting.”
CT1812 is Cognition’s lead product, designed to displace toxic protein oligomers that have attached to neurons with the aim of restoring normal cellular function. Today’s results back up Cognition’s decision to persevere with CT1812 despite the therapy’s failure in the phase 2 SHINE study to reduce symptom severity in patients with mild to moderate Alzheimer’s back in July.
At the time, Cognition CEO Lisa Ricciardi framed the results as being “comparable in magnitude to what was achieved with currently approved antibodies, with great ease of administration as a once daily dose, and less patient burden.”
The company is now “eager” to take CT1812 into late-stage trials with the hope of one day bringing the once-daily pill to market to treat “devastating neurodegenerative conditions,” Ricciardi said in today’s release.
“With the SHIMMER and SHINE results, we are confident CT1812 is a promising drug that has demonstrated broad neurologic and neuroprotective activity in DLB and Alzheimer’s disease,” Ricciardi added. “People with these diseases, particularly DLB, have few therapeutic options leading to a cascade of symptoms that are painful to the individual and their caregivers.”