ARO-RAGE / Arrowhead - LARVOL DELTA

Study of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease (clinicaltrials.gov) - P1/2 | N=275 | Active, not recruiting | Sponsor: Arrowhead Pharmaceuticals | Phase classification: P1 ➔ P1/2

Phase classification • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Study of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease (clinicaltrials.gov) - P1 | N=275 | Active, not recruiting | Sponsor: Arrowhead Pharmaceuticals | Trial primary completion date: Dec 2024 ➔ Mar 2025

Trial primary completion date • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Study of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease (clinicaltrials.gov) - P1 | N=275 | Active, not recruiting | Sponsor: Arrowhead Pharmaceuticals | Recruiting ➔ Active, not recruiting | N=149 ➔ 275

Enrollment change • Enrollment closed • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

A First-In-Human Study of ARO-RAGE, A Novel Inhaled RNA-Interference Therapy for Asthma (ATS 2024) - P1 | "ARO-RAGE has been well tolerated to date in both healthy volunteers and asthma patients. Inhalation of ARO-RAGE has not been associated with detrimental effects on lung function and resulted in minimal extra-pulmonary exposure. Prolonged and dose-responsive decreases in serum and BALF sRAGE indicate effective target engagement in the lung and support continued clinical development of ARO-RAGE."

Late-breaking abstract • P1 data • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • AGER

Arrowhead Pharmaceuticals Presents New Clinical Data Showing ARO-RAGE Achieves High Level of Gene Knockdown in Patients with Asthma (Businesswire) - P1 | N=149 | NCT05276570 | Sponsor: Arrowhead Pharmaceuticals | "Arrowhead Pharmaceuticals...today announced that new interim clinical data on ARO-RAGE, an investigational RNAi-based medicine for the treatment of inflammatory lung diseases, such as asthma, were presented at the American Thoracic Society (ATS) 2024 International Conference. Interim results from the ongoing Phase 1/2 study demonstrate that treatment with ARO-RAGE led to a reduction in soluble RAGE (sRAGE) concentration in bronchoalveolar lavage fluid (BALF) and serum in a dose-dependent manner in normal healthy volunteers (NHV) and in patients with mild to moderate asthma....In the ongoing 1001 study, ARO-RAGE achieved the following key results as of 05 April 2024: After two doses of ARO-RAGE in patients with mild to moderate asthma, serum sRAGE was reduced up to 88% with a mean maximum reduction up to 77%."

P1 data • Asthma

Arrowhead Pharmaceuticals to Participate in Upcoming May 2024 Conferences (Businesswire) - "Arrowhead Pharmaceuticals...today announced that it is scheduled to participate in the following upcoming events...A First-in-Human Study of ARO-RAGE, a Novel Inhaled RNA-Interference Therapy for Asthma."

Clinical data • Asthma

Study of ARO-RAGE in Healthy Subjects (clinicaltrials.gov) - P1 | N=43 | Completed | Sponsor: Arrowhead Pharmaceuticals | Recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease (clinicaltrials.gov) - P1 | N=142 | Recruiting | Sponsor: Arrowhead Pharmaceuticals | Phase classification: P1/2 ➔ P1 | Trial completion date: Feb 2024 ➔ Feb 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Phase classification • Trial completion date • Trial primary completion date • Asthma • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Arrowhead Presents Data on Pulmonary Pipeline at ERS 2023 (Businesswire) - "Arrowhead Pharmaceuticals...today announced data on its pipeline of pulmonary targeted RNA interference (RNAi) therapeutic candidates, including clinical results for ARO-RAGE, being presented at the European Respiratory Society (ERS) International Congress 2023 in Milan, Italy. In an ongoing Phase 1/2 clinical trial, ARO-RAGE, Arrowhead’s investigational RNAi therapeutic for the treatment of inflammatory lung diseases, achieved mean target gene knockdown of up to 90% with a maximum of 95% after a single inhaled administration....'Clinical results from the ARO-RAGE Phase 1/2 study are highly encouraging and demonstrate a significant level of target gene knockdown with a duration of effect that may enable a long dosing interval possibly up to once every two months...'"

Late-breaking abstract • P1/2 data • Asthma • Cystic Fibrosis • Respiratory Diseases

Study of ARO-RAGE in Healthy Subjects (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Arrowhead Pharmaceuticals | Trial completion date: Jul 2023 ➔ Dec 2023 | Trial primary completion date: Jul 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of ARO-RAGE in Healthy Subjects and Patients With Asthma (clinicaltrials.gov) - P1/2 | N=121 | Recruiting | Sponsor: Arrowhead Pharmaceuticals | N=80 ➔ 121

Enrollment change • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Study of ARO-RAGE in Healthy Subjects and Patients With Asthma (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Arrowhead Pharmaceuticals | Trial completion date: May 2023 ➔ Feb 2024 | Trial primary completion date: May 2023 ➔ Dec 2023

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study Evaluating the Effects of ARO-RAGE in Healthy Subjects and Patients with Asthma BADANIE OCENIAJĄCE DZIAŁANIE ARO-RAGE U ZDROWYCH OSÓB I PACJENTÓW Z ASTMĄ (clinicaltrialsregister.eu) - P1/2 | N=80 | Ongoing | Sponsor: Arrowhead Pharmaceuticals, Inc.

New P1/2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of ARO-RAGE in Healthy Subjects (clinicaltrials.gov) - P1 | N=50 | Recruiting | Sponsor: Arrowhead Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of ARO-RAGE in Healthy Subjects (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Arrowhead Pharmaceuticals

New P1 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Study of ARO-RAGE in Healthy Subjects and Patients With Asthma (clinicaltrials.gov) - P1/2 | N=80 | Recruiting | Sponsor: Arrowhead Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

"$ARWR Arrowhead Pharmaceuticals Initiates Phase 1/2a Studies for Two Pulmonary Candidates ARO-MUC5AC and ARO-RAGE https://t.co/DHMgmxRnaq" (@stock_titan)

MUC5AC

Silencing RAGE Expression with a Lung-Targeted RNAi Trigger Delivery Platform Suppresses Pulmonary Allergic Inflammation (ATS 2022) - "Inhaled AC-000292 potently and durably silences pulmonary RAGE expression and protects rats from pulmonary inflammation based on multiple inflammatory biomarkers. ARO-RAGE (ADS-015) is a promising new therapeutic candidate for the treatment of chronic pulmonary inflammation."

Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases • AGER • CHI3L1 • HMGB1 • MUC5AC