NTRX-07 / UT MD Anderson Cancer Center, Cleveland Clinic, NeuroTherapia - LARVOL DELTA

SPPN-AD: A Study of NTRX-07 in Participants With Alzheimer's Disease (clinicaltrials.gov) - P2 | N=48 | Recruiting | Sponsor: NeuroTherapia, Inc.

New P2 trial • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

NeuroTherapia Announces EMA Approval of its Phase 2 Trial for the Treatment of Alzheimer's Disease (PRNewswire) - "NeuroTherapia...announced it has received approval for its Phase 2 clinical trial from the European Medicines Agency (EMA). NTRX-07, the Company's lead molecule, will be administered to Alzheimer's disease (AD) participants for 28 days in this double-masked, randomized clinical trial....The trial will be managed by CRU Global, a leading European CRO, and conducted at sites in Hungary, Poland, and the Czech Republic....Sites are currently completing training for administrating qEEG and P300 ERP recordings, with patient enrollment expected to begin in February."

New P2 trial • Alzheimer's Disease

A phase 1b double-blind multiple ascending dose study and a randomized placebo-controlled phase 2a study of NTRX-07 in participants with Alzheimer's disease (Neuroscience 2024) - "In addition, the free-water MRI and neuroinflammatory CSF biomarkers will potentially link the changes in neuroinflammation to improved neuronal activity, translating the results observed in the preclinical animal studies. Furthermore, a change in a plasma biomarker following NTRX-07 treatment could be used to inform the subsequent trial as an inclusion criterion."

Clinical • Late-breaking abstract • P1 data • P2a data • Alzheimer's Disease • CNS Disorders

NeuroTherapia Raises $12.3M in the First Close of its Series B Financing (PRNewswire) - "NeuroTherapia, Inc...announced today the first closing of its Series B financing with $12.3M in funding...NeuroTherapia is using this funding primarily for the continued clinical development of NTRX-07, an orally available cannabinoid receptor agonist, for the treatment of Alzheimer's disease (AD). The company will continue to raise additional funds for its second close in six months, which will enable development of a recently discovered second generation molecule for a separate indication in which neuroinflammation plays a major role...In addition to the Phase 2a trial, NeuroTherapia will use funding from this financing to study NTRX-07 in a preclinical model of ARIA...in combination with therapeutic monoclonal antibodies."

Financing • Alzheimer's Disease • CNS Disorders

NeuroTherapia Receives Grant from Alzheimer’s Association for Development of First-in-Class Drug for Alzheimer’s Disease (PRNewswire) - "NeuroTherapia...announced today that it has received a grant from the Alzheimer's Association Part the Cloud program for the development of its first-in-class drug, NTRX-07, for the treatment of Alzheimer's disease (AD)."

Financing • Alzheimer's Disease • CNS Disorders

A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07 (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: NeuroTherapia, Inc.

New P1 trial • Alzheimer's Disease • CNS Disorders • Aβ42 • CHI3L1 • CRP • IL1B • IL2 • IL6 • TNFA

Safety and Tolerability of NTRX-07 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: NeuroTherapia, Inc. | Unknown status ➔ Completed

Trial completion • Neuralgia • Pain

A Phase 1b Double Blind Multiple Ascending Dose Study of the Safety and Pharmacokinetics of NTRX-07 in Normal Volunteers and Patients with Mild Cognitive Impairment or Early Alzheimer's Disease (CTAD 2023) - "NTRX-07 was safely administered for 7 days at doses up to 90 mg/day. The primary side effect observed was mild transient orthostatic changes in blood pressure, usually with early doses. Plasma levels were within the target ranges based on the allometric scaling of preclinical data."

Clinical • P1 data • PK/PD data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Inflammation • Ophthalmology

NeuroTherapia Presents Clinical Data from Phase 1b Clinical Trial of NTRX-07 for the Treatment of Alzheimer’s Disease (GlobeNewswire) - P1 | N=32 | "NeuroTherapia, Inc...announced the presentation of clinical data from its Phase 1b clinical trial of NTRX-07...at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, taking place in Boston, Mass., Oct. 24-27, 2023....Several cognitive function measures were evaluated within the cohort of AD patients. While the trial was not powered to detect a significant change in cognitive scores, an interesting trend toward improvement was observed in AD participants using the Alzheimer’s Disease Assessment Scale–cognitive subscale (ADAS-Cog) test. Of 6 treated patients tested with ADAS-Cog, all 6 showed a reduction in the number of errors following treatment, with 3 having clinically meaningful improvements (3-4 point score reduction). In contrast, neither of the non-treated AD patients showed an improvement."

P1 data • Alzheimer's Disease • CNS Disorders

NeuroTherapia Announces Completion of Phase 1a Clinical Trial (PRNewswire) - "NeuroTherapia, Inc....announced today the completion of its first-in-human study of NTRX-07. This study was a single ascending dose clinical trial carried out in healthy volunteers. 'The lack of dose-limiting toxicity gives us great confidence that this product will be safe for use in patients following longer-term administration...We were also enthusiastic about the blood levels of NTRX-07 achieved following dosing'...We anticipate initiating a 28-day study in subjects suffering from Alzheimer's Disease to understand the safety and pharmacokinetic profile of repeat doses in patients and will include an analysis of measures of inflammation before and after treatment to provide an early indication of bioactivity."

New trial • Trial completion • Alzheimer's Disease • CNS Disorders • Neuralgia • Pain

NeuroTherapia Closes $8.8M Series A Financing Led By Brain Trust Accelerator Fund II (PRNewswire) - "NeuroTherapia, Inc....announced today the closing of its Series A financing of $8.8M....NeuroTherapia is currently completing its first-in-human clinical trial using NTRX-07 with funding provided in part by a grant from the Alzheimer's Association. The company will use the Series A funds to finish this work while also undertaking a number of preclinical studies."

Financing • Alzheimer's Disease • CNS Disorders

[VIRTUAL] A Phase I Single Ascending Dose Safety Study of NTRX-07 in Normal Volunteers (AAIC 2020) - "There are currently no commercially available CB2 agonists. NTRX07 would represent the first-in-class of a new therapeutic agent to treat microglial-mediated neuroinflammation in a variety of diseases where the CB2 receptor has been shown to be active such as AD, ALS and FTD. The next study will be a 28 day repeat dose of NTRX-07, in patients with MCI or early AD, for safety, PK and exploratory biomarkers."

Clinical • P1 data • Alzheimer's Disease • CNS Disorders • Immunology

Safety and Tolerability of NTRX-07 in Healthy Volunteers (clinicaltrials.gov) - P1; N=48; Active, not recruiting; Sponsor: NeuroTherapia, Inc.

Clinical • New P1 trial