CuraSen Therapeutics has commenced its Phase IIa proof-of-concept trial of CuraAX (CST-3056) with dosing of the first patient to treat neurogenic orthostatic hypotension (nOH).
nOH is a condition that causes a sudden drop in blood pressure upon standing and affects subjects with Parkinson’s disease (PD), multiple system atrophy (MSA), pure autonomic failure (PAF), and dementia with lewy bodies (DLB).
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CuraAX is administered as oral tablet and acts as a selective partial α1A-adrenergic receptor agonist with central nervous system penetration. It aims to stabilise blood pressure while maintaining cerebral blood flow.
CuraSen Therapeutics CEO Kathleen Glaub said: “Dosing our first patient in this Phase IIa trial marks an important milestone for CuraAX and for patients living with nOH. Our Phase I trial in healthy volunteers showed encouraging safety, tolerability and pharmacologic activity.
“Unlike current treatments, which are limited by non-selective prodrug mechanisms, variable pharmacokinetics, burdensome dosing regimens and significant side effects, CuraAX has the potential to deliver stable, durable efficacy, improved safety and meaningful cognitive benefit.”
The dose-ranging trial will assess the impact, safety and tolerability on orthostatic signs in subjects with nOH and Parkinson’s or PAF.
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By GlobalDataSet to enrol up to 12 subjects, it will be conducted at centres in New York and New Jersey, and at the Vanderbilt Autonomic Dysfunction Center in the US.
Subjects will be blinded to receive placebo and varying doses of CPT-3056 over five days.
The primary goal of the trial is change in standing systolic blood pressure, with secondary endpoints including the Orthostatic Hypotension Symptom Assessment (OHSA).
Earlier investigational new drug (IND)-enabling and Phase I clinical trials received funding from the Alzheimer’s Drug Discovery Foundation (ADDF).
CuraSen’s pipeline also includes CuraXN and CuraCN oral CNS-penetrant β2-adrenergic receptor agonists.
Further trials are planned for the treatment of progressive supranuclear palsy and Alzheimer’s.
