CuraSen Therapeutics has reported positive results from a Phase II clinical trial with oral, brain-permeant beta2 adrenoceptor (β2-AR) agonist, CST-103, in patients with Parkinson’s disease (PD) or mild cognitive impairment (MCI).
CST-103 is administered along with brain-sparing β-AR blocker CST-107 for reducing known cardiometabolic side effects of β2-AR agonists.
From the Phase II trial, the company reported top-line safety, tolerability and proof of concept data, with early efficacy benefit.
The double-blinded, randomised, two-period crossover trial enrolled 41 patients with neurodegenerative disease and was conducted at sites in the UK, Australia, New Zealand and the European Union.
It assessed the tolerability, safety and CNS effects of CST-103/CST-107 treatment administered once a day, against matched placebo.
Most of the subjects enrolled in the trial had Parkinson’s disease, and specifically a history of REM-sleep behavior disorder (PDRBD).
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The CST-103/CST-107 combination was found to be safe and well-tolerated.
Importantly, it was observed that co-administration of CST-107 eliminated adverse events (AEs) common to the β2-AR agonist class of drugs when given alone.
The clinical trial also revealed improvements in several quantitative test measures of cognition in patients treated with the combination.
CuraSen Therapeutics CEO Anthony Ford said: “These data provide strong support for the long-term development of CNS-active β2-AR agonists and validate CuraSen’s unique drug combination approach to treating poorly addressed symptoms in patients with neurodegenerative disease.
“From a strategic standpoint, we were able to clearly assess the effects of CST-103 on cognitive function and other endpoints without the dose-limiting AEs normally seen with these agonists.
“Furthermore, the cognitive findings seen in the majority of patients with PDRBD bode well for our plans to launch a larger and longer Phase 2b study in 2023 in this population.”