CuraSen Therapeutics Presents Positive Phase 1 Safety, Pharmacokinetics and Pharmacodynamics Data with CuraAX (CST-3056) at the 2025 American Autonomic Society (AAS) International Symposium

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SAN CARLOS, Calif.--(BUSINESS WIRE)--Nov 10, 2025--

CuraSen Therapeutics, Inc., a biopharmaceutical company developing drug candidates with broad applicability in neurodegenerative and neuropsychiatric diseases, today announced encouraging results from a Phase 1 study with CuraAX (CST-3056). Data were presented by Gabriel Vargas, MD, PhD, chief medical officer, CuraSen Therapeutics, in both an oral and poster presentation at the 36 th International Symposium on the Autonomic Nervous System, held November 5-8 in Clearwater Beach, FL.

CuraAX is an oral, selective, partial alpha-1A adrenoceptor ( α 1A-AR) agonist in clinical development for the treatment of neurogenic orthostatic hypotension (nOH). nOH is a serious condition characterized by a sudden drop in blood pressure when a person moves from a supine or sitting position to standing, resulting in falls, dizziness, fainting and cognitive impairment due to a lack of blood flow to the brain. As a CNS-penetrant compound, CuraAX has the potential to provide additional cognitive benefit.

Phase 1 Study Results

The Phase 1 study evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CuraAX in 56 healthy volunteers at doses ranging from 6 mg to 180 mg. Results demonstrated:

• Strong safety and tolerability with few drug-related adverse events - all of them mild - through the maximum tolerated dose of 90 mg
• Desirable PK with rapid and consistent absorption ideal for control of nOH symptoms
• Clear α1A-AR pharmacodynamics showing dose-dependent ‘baroreflex’ reductions in supine heart rate in the Phase 1 healthy subjects, reflect the desired drug effect of CuraAX in nOH patients, who lack normal sympathetic reflexes

“These Phase 1 data highlight the potential of CuraAX to stabilize blood pressure and cerebral perfusion upon standing as well as address cognitive symptoms associated with neurogenic orthostatic hypotension,” said Kathleen Sereda Glaub, chief executive officer, CuraSen Therapeutics. “We expect CuraAX to deliver a best-in-class treatment option for nOH patients (and their caregivers) by affording them greater mobility, independence, improved cognition and a higher quality of life for longer as a result.”

The company is currently conducting a Phase 2a, dose-ranging proof-of-concept study to evaluate CuraAX’s safety, tolerability and impact on orthostatic symptoms in patients with nOH due to Parkinson’s disease (PD) or Pure Autonomic Failure (PAF).

nOH affects nearly 700,000 patients in the U.S living with PD and related alpha-synuclein disorders, leading to severe dizziness, dangerous falls, fainting, hospitalizations and cognitive impairment due to reduced blood flow to the brain. Because both patients and caregivers fear potential falls, this often leads to greater inactivity, de-conditioning and acceleration of disease progression. noH is associated with higher morbidity and mortality in these populations.

IND-enabling and Phase 1 studies for CuraAX were supported with funding from the Alzheimer’s Drug Discovery Foundation (ADDF).

In addition to CuraAX, CuraSen’s pipeline includes CuraCN (CST-103/CST-107) and CuraXN (CST-2032/CST-107), oral, CNS-penetrant β 2 -adrenergic receptor agonists combined with nadolol, a peripherally restricted beta-blocker. Designed to restore adrenergic function that is lost early in neurodegenerative diseases, both drug candidates have shown cognitive benefit in a variety of tests in Phase 2 proof-of-concept studies in Parkinson’s and Alzheimer’s disease, with future trials planned in progressive supranuclear palsy (PSP) and Alzheimer’s.

About CuraSen Therapeutics

CuraSen is focused on the development of new treatments for neurodegenerative and neuropsychiatric diseases targeting mechanisms with broad applicability, including neurogenic orthostatic hypotension, Parkinson’s and Alzheimer’s disease, and certain orphan indications. CuraSen’s drugs are small molecules, given as oral tablets, designed to directly activate certain receptor populations in the brain and periphery to compensate for decline of the adrenergic system driven by aging and neurologic disease. For more information, please visit www.curasen.com.

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SOURCE: CuraSen Therapeutics, Inc.

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PUB: 11/10/2025 09:00 AM/DISC: 11/10/2025 09:01 AM

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