inhaled cromolyn sodium (AZT-101) / AZTherapies - LARVOL DELTA

A Systematic Review and Network Meta Analysis of Pharmacologic Disease-Modifying Therapies for Early Alzheimer's Disease (ISPOR-EU 2025) - "Comparators were standard of care (SoC), which may include acetylcholinesterase inhibitors and/or memantine, or any other listed intervention...Following a feasibility assessment, seven RCTs, investigating five DMTs (lecanemab, donanemab, blarcamesine, ALZT-OP1a/1b, and AGB108) were included in the NMA... Several AD DMTs are in the horizon. The RR of SAEs should be considered, when considering alternative AD treatment classes to mitigate the risk of ARIAs."

Retrospective data • Review • Alzheimer's Disease • CNS Disorders • Dementia

Safety and Efficacy of ALZT-OP1a as Adjuvant Treatment in Subjects With Post-Ischemic Stroke Cognitive Impairment (PSCI) (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: AZTherapies, Inc. | N=80 ➔ 0 | Trial completion date: Nov 2021 ➔ Dec 2024 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Aug 2021 ➔ Dec 2024

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Alzheimer's Disease • Cardiovascular • Cognitive Disorders • Ischemic stroke

A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease (clinicaltrials.gov) - P2a; N=12; Terminated; Sponsor: AZTherapies, Inc.; N=80 ➔ 12; Active, not recruiting ➔ Terminated; Low enrollment

Biomarker • Clinical • Enrollment change • Trial termination • Amyotrophic Lateral Sclerosis • CNS Disorders • CXCL1 • CXCL8 • IL10 • IL15 • IL17A • IL1B • IL2 • IL5 • IL6 • TNFA

A Safety and Biomarker Study of ALZT-OP1a in Subjects With Mild-Moderate ALS Disease (clinicaltrials.gov) - P2a; N=80; Active, not recruiting; Sponsor: AZTherapies, Inc.; Recruiting ➔ Active, not recruiting

Enrollment closed • Amyotrophic Lateral Sclerosis • CNS Disorders • Complement-mediated Rare Disorders • CXCL1 • CXCL8 • IL10 • IL15 • IL17A • IL1B • IL2 • IL5 • IL6 • TNFA • Tryptase

AZTherapies Doses First Patient in Phase 2a Study of ALZT-OP1a in Amyotrophic Lateral Sclerosis (ALS) (GlobeNewswire) - “AZTherapies…announced the dosing of the first patient in its Phase 2a clinical trial examining the safety and efficacy of ALZT-OP1a in patients with mild- to moderate-stage Amyotrophic Lateral Sclerosis (ALS)…. The company-sponsored trial, AZT-006 (NCT04428775), is expected to enroll 80 patients at up to 20 centers across the U.S.”

Enrollment status • Amyotrophic Lateral Sclerosis • CNS Disorders

AZTherapies Announces Publication of Data Supporting the Targeting of Neuroinflammation in the Treatment of ALS in Scientific Reports (GlobeNewswire, AZTherapies, Inc.) - "Anti-inflammatory drug cromolyn successfully delayed disease onset and was neuroprotective in a mouse model of ALS. Company expects to advance its re-engineered inhaled cromolyn candidate AZT-101 into clinical development for patients with ALS in 1H 2020."

Preclinical