Cognition Therapeutics has announced the dosing of the first Alzheimer’s patient in a Phase 1b clinical trial of its drug candidate, CT1812, for the treatment of mild to moderate Alzheimer’s disease (AD).
CT1812 is a proprietary, first-in-class, orally available, drug-like small molecule designed to displace bound amyloid beta oligomers (molecules thought to be key agents in the onset of Alzheimer’s disease). It inhibits the binding of amyloid beta oligomers to the receptor complex. By competing with amyloid beta oligomers for critical receptor targets, CT1812 works to both target and displace the toxic protein and prevent the damage its buildup can cause.
CT1812 has been shown to stop and reverse memory loss in preclinical Alzheimer’s disease models, the company reported. In a Phase 1a study (NCT02570997), the drug was also found to be safe at multiple ascending dose levels in 94 healthy volunteers, 74 of whom were on a once daily CT1812 oral dosing schedule for up to two weeks.
The randomized and placebo-controlled Phase 1b trial (NCT02907567) is designed to evaluate the safety, tolerability and pharmacokinetic profile of CT1812 in mild to moderate AD patients. Enrolled participants will be randomized to one of two doses (280mg or 560mg) daily for 28 days, or to placebo. Results, expected in mid-2017, will help to inform a larger Phase 2 study of CT1812 in similar Alzheimer’s patients.
Taking place in Australia, this trial is currently recruiting patients. More information is available on its clinical trials.gov webpage or by clicking on the trial identification number above.
“Evidence suggests that CT1812 has the potential to rapidly reverse the memory loss seen in Alzheimer’s disease and to stop disease progression,” Susan Catalano, chief scientific officer and Cognition Therapeutics’ founder, said in a press release. Catalano, who led the CT1812 research team, added, “CT1812’s novel mechanism of action as the first orally active drug that displaces beta amyloid oligomers represents a potentially major therapeutic advance for the millions of individuals suffering from Alzheimer’s disease.”
COG0102’s clinical development is supported, in part, by an award from the National Institute on Aging, part of the National Institutes of Health.
“The dosing of patients with Alzheimer’s disease is a major milestone for Cognition and CT1812,” Kenneth I. Moch, the company’s president and CEO, said. “We are pleased by the pace of CT1812’s clinical program and remain on track to initiate additional trials in 2017 which will further demonstrate the therapeutic potential of CT1812.”
In addition to CT1812, company researchers are investigating a number of other strategies to target receptors and pathways central to the pathology of Alzheimer’s disease.
Additional information about Cognition may be found online at www.cogrx.com
Cognition Therapeutics, Inc.