AP-101 / AL-S Pharma - LARVOL DELTA

Safety and Dosimetry of a New Radiotracer to Detect Misfolded SOD1 Associated With Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Université de Sherbrooke | Trial completion date: Jul 2024 ➔ Dec 2024 | Trial primary completion date: May 2024 ➔ Nov 2024

Trial completion date • Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders

A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - P2 | N=63 | Active, not recruiting | Sponsor: AL-S Pharma | Trial primary completion date: Jan 2024 ➔ Dec 2024

Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders • SOD1

A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - P2 | N=63 | Active, not recruiting | Sponsor: AL-S Pharma | Recruiting ➔ Active, not recruiting | Phase classification: P2a ➔ P2 | Trial completion date: Jan 2025 ➔ Sep 2025 | Trial primary completion date: Jun 2024 ➔ Jan 2024

Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders • SOD1

Safety and Dosimetry of a New Radiotracer to Detect Misfolded SOD1 Associated With Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: Université de Sherbrooke | Not yet recruiting ➔ Recruiting

Enrollment open • Amyotrophic Lateral Sclerosis • CNS Disorders

Safety and Dosimetry of a New Radiotracer to Detect Misfolded SOD1 Associated With Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Université de Sherbrooke

New P1 trial • Amyotrophic Lateral Sclerosis • CNS Disorders

A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - P2a | N=63 | Recruiting | Sponsor: AL-S Pharma | Trial completion date: Jul 2024 ➔ Jan 2025

Trial completion date • Amyotrophic Lateral Sclerosis • CNS Disorders • NEFH • NEFL • SOD1

A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - P2a | N=63 | Recruiting | Sponsor: AL-S Pharma | Trial completion date: Jul 2023 ➔ Jul 2024 | Trial primary completion date: Jun 2023 ➔ May 2024

Trial completion date • Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders • NEFH • NEFL • SOD1

Neurimmune and TVM Capital Life Science Announce the Initiation of AL-S Pharma's Phase 2 Study of AP-101 for the Treatment of ALS (PRNewswire) - "AL-S Pharma AG...announced today enrollment of the first patient in a multicenter, placebo-controlled Phase 2 clinical trial to evaluate AP-101 in patients with amyotrophic lateral sclerosis (ALS). AP-101 is a human antibody directed against misfolded superoxide dismutase 1 (SOD1)....The Phase 2 trial will assess safety, tolerability, pharmacokinetics and pharmacodynamics of AP-101 both in patients with familial ALS with disease-causing SOD1 mutations and in patients with sporadic forms of ALS."

Trial status • Amyotrophic Lateral Sclerosis • CNS Disorders

A Study to Evaluate, Safety, Tolerability, Pharmacodynamic (PD) Markers and Pharmacokinetics (PK) of AP-101 in Participants With Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - P2a; N=63; Recruiting; Sponsor: AL-S Pharma

Clinical • New P2a trial • Amyotrophic Lateral Sclerosis • CNS Disorders • NEFH

A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - P1; N=18; Active, not recruiting; Sponsor: AL-S Pharma; Trial primary completion date: Aug 2020 ➔ Nov 2020

Clinical • Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders • Complement-mediated Rare Disorders

A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: AL-S Pharma; Active, not recruiting ➔ Recruiting; Trial completion date: May 2020 ➔ Oct 2020; Trial primary completion date: May 2020 ➔ Aug 2020

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders • Complement-mediated Rare Disorders • Pain

A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - P1; N=18; Active, not recruiting; Sponsor: AL-S Pharma; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - P1; N=18; Recruiting; Sponsor: AL-S Pharma; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Neurimmune and TVM Capital Life Science announce the initiation of AL-S Pharma's phase 1 study of AP-101 for the treatment of ALS (PRNewswire) - “AL-S Pharma AG…announced today enrollment of the first patient in a multicenter Phase 1 clinical trial to evaluate AP-101 in patients with amyotrophic lateral sclerosis (ALS). AP-101 is a human antibody directed against misfolded superoxide dismutase 1 (SOD1).”

New P1 trial