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

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