PLL001 / PLL Therap - LARVOL DELTA

A Study to Evaluate the Safety, Efficacy, and Pharmacodynamics of PLL001 in ALS Patients (clinicaltrials.gov) - P1/2 | N=153 | Not yet recruiting | Sponsor: PLL TX AUSTRALIA PTY LTD | Trial completion date: Dec 2026 ➔ Jun 2027

Trial completion date • Amyotrophic Lateral Sclerosis • CNS Disorders

PLL Therapeutics reports positive phase I/II data for gut-targeting ALS therapy (European Biotechnology News) - "This first phase of the trial establishes safety and tolerability of the therapy in 12 patients with ALS at three different doses by subcutaneous injection. The trial, which was double-blind and placebo-controlled, resulted in no serious adverse events and no treatment-emergent adverse events that resulted in study discontinuation....The next stage of the trial will involve 140 ALS patients in Australia and New Zealand, where PLL Therapeutics had opened a subsidiary last year. New Zealand has a disproportionately higher rate of ALS than the global average. This phase will determine how well PLL001 targets organs and inflammation, as well as its ability to restore the gut."

P1/2 data • Trial status • Amyotrophic Lateral Sclerosis

A Study to Evaluate the Safety, Efficacy, and Pharmacodynamics of PLL001 in ALS Patients (clinicaltrials.gov) - P1/2 | N=153 | Recruiting | Sponsor: PLL TX AUSTRALIA PTY LTD | Not yet recruiting ➔ Recruiting

Enrollment open • Amyotrophic Lateral Sclerosis • CNS Disorders

A Multi-centre, Phase 1/2, Randomised, Double-blind, Placebo Controlled Study With an Optional Open-label Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics of PLL001 for the Treatment of Subjects With Amyotrophic Lateral Sclerosis (clinicaltrials.gov) - P1/2 | N=153 | Not yet recruiting | Sponsor: PLL TX AUSTRALIA PTY LTD

New P1/2 trial • Amyotrophic Lateral Sclerosis • CNS Disorders