Phase 2a cognition, dementia treatment trial underway

CuraSen Therapeutics Inc. announced it has begun dosing patients in a phase 2a clinical trial with CST-2032, an oral therapeutic for treatment of mild cognitive impairment or mild dementia due to either Parkinson’s or Alzheimer’s disease.

According to a release from CuraSen, CST-2032 is administered in combination with CST-107, a beta-2 adrenoceptor blocker, to minimize known side effects of beta-2 adrenoceptor agonists. The multicenter trial, which is expected to enroll approximately 40 patients, is being conducted in the United States and New Zealand, the company stated.

“With this trial initiation, CuraSen now has two unique pipeline opportunities in ongoing phase 2 clinical studies aimed at improving the debilitating cognitive symptoms and loss of function in neurodegenerative diseases, with the ultimate goal of preventing or even reversing disease progression,” Anthony Ford, PhD, chief executive officer, CuraSen Therapeutics, said in the release.

Earlier this year, CuraSen completed a successful phase 1 study evaluating safety and tolerability of CST-2032/CST-107 at multiple doses in both healthy volunteers and patients with mild cognitive impairment. Based on encouraging safety, pharmacokinetic and pharmacodynamic results, the company advanced CST-2032/CST-107 to phase 2 development, per the release.

In the phase 2a randomized, double-blind study, trial participants are to receive daily doses of CST-2032 (coadministered with CST-107), or matching placebo, for 14 days, followed by a 1-week washout period before crossing over to the other arm. All participants will complete clinical, cognitive and additional pharmacodynamic assessments during each treatment period. Blood samples will be collected throughout the trial to assess early biomarkers of brain health.

Following completion of the trial expected early in 2023, CuraSen plans to initiate longer phase 2 studies with additional dose levels of CST-2032/CST-107 in preferred patient populations.