fosigotifator (ABBV-CLS-7262) / AbbVie, Calico Life Sciences - LARVOL DELTA

An atypical initial revelation of CACH-vanishing white matter syndrome miming herpetic encephalitis in a 6-year-old child: Case report and brief review. (PubMed, Radiol Case Rep) - "MRI is a fundamental diagnostic test with good sensitivity for establishing the diagnosis because of a very good correlation between MRI aspects and mutations in the EIF2B1-5 genes. Guanabenz and Fosigotifatorsont represent 2 promising molecules for improving quality of life and prognosis in this population."

Journal • Ataxia • CNS Disorders • Genetic Disorders • Infectious Disease • Movement Disorders • EIF2B4

Food Effect Study of Fosigotifator, an eIF2B Activator being developed as a Potential Treatment for Amyotrophic Lateral Sclerosis, Vanishing White Matter Disease, and Major Depressive Disorder (AAN 2025) - P1/2, P2/3 | "Fosigotifator may be administered without regard to food and may be administered with various soft foods such as applesauce, yogurt, cream cheese, and strawberry jam."

Amyotrophic Lateral Sclerosis • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry • EIF2B4

HEALEY ALS Platform Trial - Regimen F ABBV-CLS-7262 (clinicaltrials.gov) - P2/3 | N=310 | Completed | Sponsor: Merit E. Cudkowicz, MD | Enrolling by invitation ➔ Completed

Trial completion • Amyotrophic Lateral Sclerosis • CNS Disorders

An Open-Label Exploratory Study of Fosigotifator in Participants With Vanishing White Matter Disease (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: AbbVie | N=38 ➔ 50 | Trial completion date: Dec 2027 ➔ Nov 2029

Enrollment change • Trial completion date • CNS Disorders • Pediatrics • EIF2B4

A Study to Assess Adverse Events of Fosigotifator (ABBV-CLS-7262) in Adults With Major Depressive Disorder (clinicaltrials.gov) - P1 | N=106 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Study to Assess Adverse Events of Fosigotifator (ABBV-CLS-7262) in Adults With Major Depressive Disorder (clinicaltrials.gov) - P1 | N=106 | Not yet recruiting | Sponsor: AbbVie

New P1 trial • CNS Disorders • Depression • Major Depressive Disorder • Mood Disorders • Psychiatry

A Phase 1 Study to Investigate the Safety and Pharmacokinetics of Fosigotifator in Patients With Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: AbbVie | Trial primary completion date: Jan 2023 ➔ Nov 2025

Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders

An Open-Label Exploratory Study of Fosigotifator in Subjects With Vanishing White Matter Disease (clinicaltrials.gov) - P1/2 | N=38 | Recruiting | Sponsor: AbbVie | N=14 ➔ 38 | Trial completion date: Oct 2026 ➔ Dec 2027 | Trial primary completion date: Oct 2026 ➔ Dec 2027

Enrollment change • Trial completion date • Trial primary completion date • CNS Disorders • Pediatrics • EIF2B4

Expanded Access to Fosigotifator (clinicaltrials.gov) - P=N/A | N=0 | Available | Sponsor: AbbVie

New trial • CNS Disorders

Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: Calico Life Sciences LLC | Active, not recruiting ➔ Completed

Trial completion

A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: Calico Life Sciences LLC | Active, not recruiting ➔ Completed

Trial completion

Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration (clinicaltrials.gov) - P1 | N=7 | Active, not recruiting | Sponsor: Calico Life Sciences LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Active, not recruiting | Sponsor: Calico Life Sciences LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration (clinicaltrials.gov) - P1 | N=7 | Recruiting | Sponsor: Calico Life Sciences LLC | Not yet recruiting ➔ Recruiting

Enrollment open

Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration (clinicaltrials.gov) - P1 | N=7 | Not yet recruiting | Sponsor: Calico Life Sciences LLC

New P1 trial

HEALEY ALS Platform Trial - Master Protocol (clinicaltrials.gov) - P2/3 | N=1500 | Active, not recruiting | Sponsor: Merit E. Cudkowicz, MD | Recruiting ➔ Active, not recruiting

Enrollment closed • Amyotrophic Lateral Sclerosis • CNS Disorders

Phase 1 Asian PK Study of ABBV-CLS-7262, an eIF2B Activator Being Developed as a Potential Treatment for Amyotrophic Lateral Sclerosis and Vanishing White Matter Disease (AAN 2024) - P1, P1/2, P2/3 | "No meaningful differences in exposures after a single oral dose of ABBV-CLS-7262 in Japanese and Han Chinese vs Western subjects were observed. Dose adjustments are not needed for Asian populations."

P1 data • Amyotrophic Lateral Sclerosis • CNS Disorders • EIF2B4

Development of eIF2B Activator ABBV-CLS-7262 as a Novel Treatment for Vanishing White Matter Disease (AAN 2024) - P1/2 | "ABBV-CLS-7262 is being developed as a potential first-in-class treatment for VWM, supported by preclinical studies and Phase 1 healthy volunteer data. A Phase 1b/2 study in people with VWM has been initiated which may enable future studies."

CNS Disorders • EIF2B4

A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Calico Life Sciences LLC | Not yet recruiting ➔ Recruiting

Enrollment open

A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Calico Life Sciences LLC

New P1 trial

A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262 (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Calico Life Sciences LLC | Active, not recruiting ➔ Completed

Trial completion

An Open-Label Exploratory Study of ABBV-CLS-7262 Subjects With Vanishing White Matter Disease (clinicaltrials.gov) - P1/2 | N=14 | Recruiting | Sponsor: Calico Life Sciences LLC | Phase classification: P1b ➔ P1/2 | Trial completion date: Mar 2025 ➔ Oct 2026 | Trial primary completion date: Mar 2025 ➔ Oct 2026

Phase classification • Trial completion date • Trial primary completion date • CNS Disorders • Pediatrics • EIF2B4

A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262 (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Calico Life Sciences LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262 (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Calico Life Sciences LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date

A Phase 1 Study Assessing the Effect of Food on the Pharmacokinetics of ABBV- CLS-7262 (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Calico Life Sciences LLC

New P1 trial