CST-2032 / CuraSen Therap - LARVOL DELTA

CuraSen Therapeutics Announces Oral Presentation of Additional Positive Phase 2a Data with CST-2032/CST-107 in Patients with Alzheimer’s or Parkinson’s Disease at AD/PD 2024 International Conference (Businesswire) - P2a | N=64 | NCT05104463 | Sponsor: CuraSen Therapeutics, Inc | "CuraSen Therapeutics, Inc...announced that it will present additional positive Phase 2a data with its combination adrenergic activator, CST-2032/CST-107...The oral presentation will take place at AD/PD 2024: The International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders, being held March 5-9, 2024, in Lisbon, Portugal...Digit Symbol Substitution test, which measures complex attention, memory and executive function: AD patients with MCI = 0.36 effect size; p=0.02 on Day 14...Excellent safety and tolerability profile No serious adverse events: no increases in heart rate observed one to four hours after dose...The company plans to initiate longer studies with both CST-2032/CST-107 and CST-103/CST-107 in AD and PD patients with MCI later this year, as well as develop fixed-dose combination tablets for each of these drug candidates."

P2a data • Alzheimer's Disease • CNS Disorders • Dementia • Parkinson's Disease

A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease (clinicaltrials.gov) - P2 | N=64 | Completed | Sponsor: CuraSen Therapeutics, Inc. | Recruiting ➔ Completed

Trial completion • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Movement Disorders • Parkinson's Disease

A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: CuraSen Therapeutics, Inc. | Phase classification: P2a ➔ P2 | Trial completion date: Dec 2023 ➔ Mar 2024

Phase classification • Trial completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Movement Disorders • Parkinson's Disease

CST-2032, A NOVEL BETA-2 ADRENOCEPTOR AGONIST, IMPROVES COGNITION IN PATIENTS WITH IMPAIRMENT TO AD OR PD (ADPD 2024) - "The β2-AR agonist, CST-2032+nadolol improved performance in cognitive tasks and was well-tolerated. These data support longer-term evaluation of CST-2032+nadolol."

Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia

Combination Treatment of a Novel β2 Adrenoceptor Agonist, CST-2032, and Nadolol Improves Cognitive (CTAD 2023) - P2a | "AD subjects had impaired cognition at enrollment. Short-term treatment with the β2-AR agonist, CST-2032, when administered with the peripherally restricted antagonist nadolol, significantly improved performance in the DSST, a cognitive test involving attention, processing speed and executive function, as well as in measures of social cognition. Combination therapy with CST-2032+nadolol was well-tolerated."

Alzheimer's Disease • Cardiovascular • CNS Disorders • Cognitive Disorders • Dementia • Movement Disorders

A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease (clinicaltrials.gov) - P2a | N=60 | Recruiting | Sponsor: CuraSen Therapeutics, Inc. | Trial primary completion date: Jun 2023 ➔ Nov 2023

Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Movement Disorders • Parkinson's Disease

CuraSen Therapeutics to Present Phase 2 Data Showing Rapid-Onset Cognition and Mood Benefit with CST-103/CST-107 (Clenbuterol/Nadolol) in Parkinson’s Disease at the Alzheimer’s Disease and Parkinson’s Disease (AD/PD’23) Conference (Businesswire) - P1 | N=N/A | NCT05033912 | Sponsor: CuraSen Therapeutics, Inc. | "Additionally, the company will present promising Phase 1 data with a second program, CST-2032/CST-107, in healthy participants and patients with mild cognitive impairment (MCI)....Phase 1 Study with CST-2032/Nadolol in Mild Cognitive Impairment (MCI)....Results showed that treatment with CST-2032/nadolol...Was safe and well tolerated. Increased cerebral blood flow, a biomarker for target engagement, in brain regions involved in memory, alertness and arousal....Based on the strength of these data, CuraSen has initiated a Phase 2a exploratory, randomized, placebo-controlled, double-blinded crossover study with CST-2032/CST-107 in up to 60 patients with MCI or mild dementia due to either Alzheimer’s or Parkinson’s disease. The trial is taking place at 20 centers in the U.S. and New Zealand, with results anticipated later in 2023."

P1 data • P2a data • Trial status • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Parkinson's Disease

A PHASE 1 SAFETY, PHARMACOKINETICS AND PHARMACODYNAMIC STUDY OF CST-2032: A NOVEL, SELECTIVE, CNS-PENETRATING ΒETA-2 ADRENOCEPTOR AGONIST FOR TREATMENT OF COGNITIVE IMPAIRMENT (ADPD 2023) - "Conclusions CST-2032 was well tolerated, and was associated with CNS effects including improvements in cognition and increases in cerebral perfusion in the presence of CST-107 exposures that attenuated the risk of peripheral effects. These data support further development of CST-2032."

Clinical • P1 data • PK/PD data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Movement Disorders • Parkinson's Disease

A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease (clinicaltrials.gov) - P2a | N=60 | Recruiting | Sponsor: CuraSen Therapeutics, Inc. | N=40 ➔ 60

Enrollment change • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Movement Disorders • Parkinson's Disease

A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease (clinicaltrials.gov) - P2a | N=40 | Recruiting | Sponsor: CuraSen Therapeutics, Inc. | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Nov 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Movement Disorders • Parkinson's Disease

CuraSen Therapeutics Announces First Patients Treated with Novel Combination Therapy (CST-2032/CST-107) in Phase 2a Study of Mild Cognitive Impairment (MCI) or Mild Dementia Due to Parkinson’s or Alzheimer’s Disease (Businesswire) - “CuraSen Therapeutics, Inc…announced that it has begun dosing patients in a Phase 2a clinical trial with CST-2032…The goal of the study is to evaluate the effects of CST-2032 on cognition and mood in patients with mild cognitive impairment or mild dementia due to either Parkinson’s or Alzheimer’s disease. CST-2032 is administered in combination with CST-107...The multi-center trial, which is expected to enroll approximately 40 patients, is being conducted in the United States and New Zealand….Following completion of the trial, expected early next year, CuraSen plans to initiate longer Phase 2 studies with additional dose levels of CST-2032/CST-107 in preferred patient populations. Phase 2 Top-line Data Expected in Third Quarter 2022 with Second Drug Candidate (CST-103/CST-107) in Neurodegenerative Diseases”

P2 data • Trial completion date • Trial status • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Parkinson's Disease

A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease (clinicaltrials.gov) - P2a | N=40 | Recruiting | Sponsor: CuraSen Therapeutics, Inc. | Trial primary completion date: Jul 2022 ➔ Nov 2022

Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Movement Disorders • Parkinson's Disease

A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease (clinicaltrials.gov) - P2a | N=40 | Recruiting | Sponsor: CuraSen Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Movement Disorders • Parkinson's Disease

A Study of CST-2032 and CST-107 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Parkinson's or Alzheimer's Disease (clinicaltrials.gov) - P2a; N=40; Not yet recruiting; Sponsor: CuraSen Therapeutics, Inc.

Clinical • New P2a trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • Movement Disorders • Parkinson's Disease • MRI

A Study of CST-2032 in Subjects With Cognitive Impairment (clinicaltrials.gov) - P1; N=0; Withdrawn; Sponsor: CuraSen Therapeutics, Inc.; N=16 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Movement Disorders • Parkinson's Disease • MRI

A Study of CST-2032 in Subjects With Cognitive Impairment (clinicaltrials.gov) - P1; N=16; Not yet recruiting; Sponsor: CuraSen Therapeutics, Inc.

Clinical • New P1 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Movement Disorders • Parkinson's Disease • MRI