EQU-001 / Equilibre Biopharma - LARVOL DELTA

Long-term administration of EQU-001 (ivermectin) suppresses spasms in a rat model of infantile epileptic spasms syndrome. (PubMed, Epilepsy Res) - "None of the nicotinic cholinergic α7 drugs mimicked or prevented effects of ivermectin. Our data indicate that ivermectin may become a powerful tool in the armamentarium for treatment of IESS, however the mechanisms of this action remain to be determined."

Journal • Preclinical • CNS Disorders • Epilepsy

Study of EQU-001 for Uncontrolled Focal Onset Seizures (clinicaltrials.gov) - P2 | N=27 | Terminated | Sponsor: Equilibre Biopharmaceuticals B.V. | N=300 ➔ 27 | Trial completion date: Oct 2025 ➔ Jul 2023 | Recruiting ➔ Terminated | Trial primary completion date: Oct 2024 ➔ Jul 2023; insufficient funding to complete the study

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • CNS Disorders • Epilepsy

A Phase 2a Randomized Double-Blind Dose Finding Study to Assess Safety, Tolerability and Efficacy of Adjunctive EQU-001 in Adults with Epilepsy (AES 2023) - P2 | "Over 12-weeks of continuous therapy, EQU-001 demonstrated excellent safety profile and 60 mg daily dose of EQU-001 was able to induce clinically meaningful reductions in focal seizure frequency in adults with epilepsy. These findings warrant further study of EQU-001 in a randomized trial in a larger patient population."

Clinical • P2a data • CNS Disorders • Epilepsy • Fatigue

Pharmacodynamic Analysis to Evaluate Pro-inflammatory Cytokines Levels in Peripheral Blood Samples from Patients with Epilepsy After Oral Administration of EQU-001 (AES 2023) - P2 | "Over twelve weeks of continuous therapy, EQU-001 60 mg daily significantly reduced the plasma levels of pro-inflammatory cytokines IL-17 and IL-1b, which could have contributed to the favorable clinical outcome, and was accompanied by excellent safety profile in adult patients with epilepsy. This data demonstrates the anti-inflammatory potential of EQU-001 and future studies in a larger patient population will further clarify the role of these pro-inflammatory cytokines (and others) in epilepsy pathophysiology."

Clinical • PK/PD data • CNS Disorders • Epilepsy • IFNG • IL10 • IL17A • IL1B • IL23A • IL6 • TNFA

Study of EQU-001 for Uncontrolled Focal Onset Seizures (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Equilibre Biopharmaceuticals B.V. | Trial completion date: Jan 2027 ➔ Oct 2025 | Trial primary completion date: Jan 2025 ➔ Oct 2024

Trial completion date • Trial primary completion date • CNS Disorders • Epilepsy

Safety, Tolerability, and Exploratory Efficacy of Adjunctive EQU-001 for Seizures in Adults With Epilepsy (clinicaltrials.gov) - P2 | N=43 | Active, not recruiting | Sponsor: Equilibre Biopharmaceuticals B.V. | Completed ➔ Active, not recruiting | Trial completion date: Oct 2022 ➔ Oct 2023

Enrollment closed • Trial completion date • CNS Disorders • Epilepsy

Safety, Tolerability, and Exploratory Efficacy of Adjunctive EQU-001 for Seizures in Adults With Epilepsy (clinicaltrials.gov) - P2 | N=43 | Completed | Sponsor: Equilibre Biopharmaceuticals B.V. | Recruiting ➔ Completed

Trial completion • CNS Disorders • Epilepsy

Equilibre Biopharmaceuticals Announces Positive Topline Results from Phase 2 Clinical Trial of EQU-001 (NCT05063877) for Safety, Tolerability and Preliminary Efficacy as Adjunctive Therapy for Focal Seizures in Adults with Epilepsy (PRNewswire) - P2 | N=40 | NCT05063877 | Sponsor: Equilibre Biopharmaceuticals B.V. | "Equilibre Biopharmaceuticals Corp...reported positive topline results from the Phase 2 clinical trial evaluating the clinical safety, tolerability, and preliminary efficacy of EQU-001...EQU-001 was safe and well-tolerated with no treatment-related serious adverse events (SAEs). All treatment emergent adverse events (TEAEs) were grade 2 or less....There was an overall dose response trend with increasing median percent reductions from 10 mg through 60 mg excepting the 40 mg group. The median percent reduction (95%CI) in focal seizures per 28 days in the mITT population was 41.6% (-5.6 to 83.5), 7.4% (-51.3 to 29.1), 19.9% (-33.6 to 50.2), 12.3% (-32.1 to 83.1), and 5.8% (-110 to 36.9) in 60 mg, 40 mg, 20 mg, 10 mg, and placebo treatment arms, respectively."

P2 data • CNS Disorders • Epilepsy

Study of EQU-001 for Uncontrolled Focal Onset Seizures (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Equilibre Biopharmaceuticals B.V. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Epilepsy

Study of EQU-001 for Uncontrolled Focal Onset Seizures (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Equilibre Biopharmaceuticals B.V.

New P2 trial • CNS Disorders • Epilepsy

Safety, Tolerability, and Exploratory Efficacy of Adjunctive EQU-001 for Seizures in Adults With Epilepsy (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Equilibre Biopharmaceuticals B.V. | Trial primary completion date: Jun 2022 ➔ Oct 2022

Trial primary completion date • CNS Disorders • Epilepsy

Safety, Tolerability, and Pharmacokinetics of EQU-001 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=81 | Completed | Sponsor: Equilibre Biopharmaceuticals B.V. | Recruiting ➔ Completed | Trial completion date: May 2022 ➔ Sep 2021

Trial completion • Trial completion date

Safety, Tolerability, and Pharmacokinetics of EQU-001 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Equilibre Biopharmaceuticals | Trial completion date: Sep 2021 ➔ May 2022

Trial completion date