AP-101 / AL-S Pharma - LARVOL DELTA

AL-S Pharma...presented its Phase 2 clinical study results on AP-101 at the 36th International Symposium on ALS/MND in San Diego (PRNewswire) - "The analysis of an exploratory composite endpoint revealed that early treatment with AP-101 prolonged survival and delayed ventilatory support in comparison to study participants receiving placebo for 6 months followed by 6 months of treatment with AP-101. Positive treatment effects were observed in both the sporadic ALS cohort (p = 0.013) and the SOD1 mutation carrier cohort (p = 0.036). Effects on survival were accompanied by disease stabilization as measured by King's staging....'We plan to engage with regulators on next steps in the coming months while we prepare for the confirmatory Phase 3 study'."

New P3 trial • P2 data • Amyotrophic Lateral Sclerosis

AL-S Pharma announces positive topline results from Phase 2 study of AP-101 for the treatment of amyotrophic lateral sclerosis (ALS) (PRNewswire) - "Phase 2 of AP-101 in sporadic ALS and mutant SOD1-ALS met its primary safety and tolerability endpoint; Clinically meaningful changes in outcome measures and stabilization of biomarkers were observed; Data will be presented at upcoming scientific conferences and AL-S Pharma plans to engage with regulatory authorities later this year"

P2 data • Amyotrophic Lateral Sclerosis

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=73 | Completed | Sponsor: AL-S Pharma | Active, not recruiting ➔ Completed

Trial completion • Amyotrophic Lateral Sclerosis • CNS Disorders • NEFH • 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 | Trial primary completion date: Dec 2024 ➔ Aug 2025

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