Clinical-stage biopharmaceutical company CuraSen Therapeutics has treated the first subject in the Phase I trial of CuraAX to treat neurogenic orthostatic hypotension (nOH).
The trial aims to assess the therapy’s various dosage levels and evaluate its tolerability, pharmacokinetics, and safety in around 56 healthy volunteers alongside a supplementary food effect cohort including six subjects, which will also inform the dosing selection strategy for subsequent Phase II studies.
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The trial will examine various pharmacodynamic effects associated with alpha-1A adrenoceptor (α1A-AR) agonism to evaluate engagement of the target and potential therapeutic influence, particularly in subjects with this condition.
Also referred to as CST-3056, CuraAX is tailored to penetrate the central nervous system (CNS) and may also improve cognition across a spectrum of neurological conditions.
The Alzheimer’s Drug Discovery Foundation (ADDF), a public charity leveraging a venture philanthropy model, is providing funding for the development of CuraAX.
CuraSen Therapeutics CEO Kathleen Sereda Glaub said: “Current treatments for nOH are limited given their non-selectivity and/or indirect mode of action, leading to significant side effects; additionally, dosing regimens for standard of care products are demanding.
“CuraAX offers best-in-class potential that will provide stable and durable efficacy, improved safety, and dosing convenience, with a differentiated cognitive benefit in these patients.”
Characterised by a sudden blood pressure drop upon standing, nOH often leads to dizziness, cognitive issues, and fainting due to insufficient blood flow to the brain, the company stated.
It is a condition prevalent among individuals with Parkinson’s disease and related neurological conditions.
Beyond CuraAX, the company is developing other CNS-selective beta2 adrenoceptor agonist fixed-dose combinations, including CuraXN and CuraCN with plans to advance CuraCN to a Phase IIb trial in older subjects with major depressive disorder later this year.
In December 2022, CuraSen reported positive outcomes from a Phase II trial of CST-103 in individuals with Parkinson’s disease (PD) or mild cognitive impairment (MCI).
