ABX1100 / Aro Biotherap - LARVOL DELTA

Study to Assess the Safety, Tolerability, PK and PD of ABX1100 (clinicaltrials.gov) - P1 | N=46 | Completed | Sponsor: Aro Biotherapeutics | Active, not recruiting ➔ Completed

First-in-human • Trial completion • Pompe Disease

Study to Assess the Safety, Tolerability, PK and PD of ABX1100 (clinicaltrials.gov) - P1 | N=46 | Active, not recruiting | Sponsor: Aro Biotherapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Pompe Disease

Aro Biotherapeutics Announces Leadership Transition and Appoints Purnanand Sarma, Ph.D., as Chief Executive Officer (Businesswire) - "Dr. Sarma will be responsible for the further development of Aro’s pipeline of siRNA-conjugate medications, including the company’s lead product candidate ABX1100, a novel Centyrin-GYS1 short-interfering RNA (siRNA) drug conjugate for the treatment of Pompe disease, while preparing the company for its next stage of value creation."

Clinical • Pompe Disease

Aro Biotherapeutics Announces U.S. FDA Clearance of IND Application for ABX1100 for Potential Treatment of Late-Onset Pompe Disease (LOPD) (Businesswire) - "Aro Biotherapeutics...today announced that it has received U.S. Food and Drug Administration (FDA) clearance of the Investigational New Drug Application (IND) for ABX1100, a novel therapy currently being investigated in a phase 1 study in late-onset Pompe disease (LOPD) patients."

IND • P1 data • Pompe Disease

Aro Biotherapeutics Doses First Patient in Phase 1b Trial of ABX1100 in Late-Onset Pompe Disease (LOPD) (Businesswire) - "Trial aims to establish safety and provide proof of concept for GYS1 inhibition as promising new treatment strategy in patients with late-onset Pompe disease. Dosing milestone extends momentum of ABX1100 development program, with data from normal healthy volunteers to be presented at WORLDSymposium in February....We look forward to expanding the study beyond the current sites in Canada to other countries and anticipate reporting the results from this study later this year."

P1 data • Trial status • Pompe Disease

Study to Assess the Safety, Tolerability, PK and PD of ABX1100 (clinicaltrials.gov) - P1 | N=46 | Recruiting | Sponsor: Aro Biotherapeutics | Trial completion date: Sep 2024 ➔ Dec 2025 | Trial primary completion date: Aug 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Pompe Disease

Study to Assess the Safety, Tolerability, PK and PD of ABX1100 (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Aro Biotherapeutics | Trial completion date: Aug 2025 ➔ Sep 2024

Trial completion date

Study to Assess the Safety, Tolerability, PK and PD of ABX1100 (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Aro Biotherapeutics

New P1 trial