Presendin (exenatide sustained release) / Invex Therap - LARVOL DELTA

Invex reports promising new data on exenatide in Alzheimer’s disease model (BiotechDispatch) - "The new results build on earlier studies using Tessara’s ADBrain model, which previously demonstrated that exenatide significantly improved neuronal cell survival under conditions of oxidative stress and ferroptosis. These are processes associated with neurodegeneration...In the latest analysis, exenatide was shown to reduce neurofilament light chain (Nf-L) expression by around 40 per cent, a biomarker widely recognised as a measure of neuronal damage...The study also found that exenatide decreased the release of key pro-inflammatory cytokines, including IL-6 and IL-8, indicating a potential ability to dampen neuroinflammation, a major driver of Alzheimer’s progression....Two primary Phase 3 clinical trials (EVOLVE and EVOLVE+) are expected to report results later this year, evaluating GLP-1 drugs in patients with Alzheimer’s disease."

P3 data • Preclinical • Alzheimer's Disease

IIH EVOLVE: A Trial to Determine the Efficacy and Safety of Presendin in IIH (clinicaltrials.gov) - P3 | N=14 | Terminated | Sponsor: Invex Therapeutics Ltd. | Active, not recruiting ➔ Terminated; Following a strategic evaluation of its IIH EVOLVE Phase III clinical trial investigating Presendinâ„¢, the Invex Board has made the difficult decision that the continuation of the trial is not viable and therefore the trial has been terminated.

Trial termination • Cardiovascular • CNS Disorders • Hypertension

IIH EVOLVE: A Trial to Determine the Efficacy and Safety of Presendin in IIH (clinicaltrials.gov) - P3 | N=14 | Active, not recruiting | Sponsor: Invex Therapeutics Ltd. | Recruiting ➔ Active, not recruiting | N=240 ➔ 14 | Trial completion date: Dec 2024 ➔ Oct 2023 | Trial primary completion date: Dec 2024 ➔ Oct 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • CNS Disorders • Hypertension

A clinical trial to determine the efficacy and safety of Presendin in idiopathic intracranial hypertension (clinicaltrialsregister.eu) - P3 | N=240 | Sponsor: Invex Therapeutics Ltd.

New P3 trial • Cardiovascular • CNS Disorders • Hypertension • Immunology

IIH EVOLVE: A Trial to Determine the Efficacy and Safety of Presendin in IIH (clinicaltrials.gov) - P3 | N=240 | Recruiting | Sponsor: Invex Therapeutics Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • CNS Disorders • Hypertension • Immunology

IIH EVOLVE: A Trial to Determine the Efficacy and Safety of Presendin in IIH (clinicaltrials.gov) - P3 | N=240 | Not yet recruiting | Sponsor: Invex Therapeutics Ltd. | Initiation date: Jul 2022 ➔ Oct 2022

Trial initiation date • Cardiovascular • CNS Disorders • Hypertension • Immunology

[PREPRINT] The effect of GLP-1RA exenatide on Idiopathic Intracranial Hypertension: Randomised Clinical Trial (medRxiv) - P=N/A | N=N/A | ISTCRN12678718 | “The three primary outcome measures were intracranial pressure at 2.5 hours, 24 hours and 12 weeks and alpha set a priori at less than 0.1. Among the 16 women recruited, 15 completed the study (mean age 28+/-9, body mass index 38.1+/-6.2 kg/m2, intracranial pressure 30.6+/-5.1 cmCSF). Exenatide significantly and meaningfully lowered intracranial pressure at 2.5 hours -5.7+/-2.9 cmCSF (p=0.048); 24 hours of -6.4+/-2.9 cmCSF (p=0.030); and 12 weeks -5.6+/-3.0 cmCSF (p=0.058). No serious safety signals were noted. This data provides confidence to proceed to a phase 3 trial in idiopathic intracranial hypertension…”

Clinical data • Preprint • CNS Disorders

IIH EVOLVE: A Trial to Determine the Efficacy and Safety of Presendin in IIH (clinicaltrials.gov) - P3 | N=240 | Not yet recruiting | Sponsor: Invex Therapeutics Ltd. | Trial completion date: Jul 2023 ➔ Dec 2024 | Trial primary completion date: Mar 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • CNS Disorders • Hypertension • Immunology