AD17002 / Advagene Biopharma - LARVOL DELTA

Intra-nasal self-administration of an innate immune activator, AD17002, effective in moderate to severe eosinophilic asthmatics: a pilot proof-of-concept trial (AAAAI-WAO 2025) - "Conclusions Thus, intra-nasal self-administrated AD17002 is a safe innate immune activator. Treatment reduced sputum and blood eosinophil counts, leading to improved lung functions in moderate to severe eosinophilic asthmatics."

Asthma • Eosinophilia • Immunology • Respiratory Diseases • CD4 • IL5

Safety, tolerability, and efficacy of intranasally-administered detoxified LTh(αK) in mild-to-moderate COVID-19 patients: A randomized, double-blinded, placebo-controlled phase 2 study. (PubMed, Hum Vaccin Immunother) - "The enhancement in clinical recovery by AD17002 within 5 days after symptom onset was observed but did not achieve statistical significance. According to the results, intranasal administration of AD17002 was safe, well-tolerated, and potentially effective for treating mild-to-moderate COVID-19."

Clinical • Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Evaluating Safety, Tolerability, and Potential Efficacy of Intranasal AD17002 in Adults With Mild to Moderate COVID-19 (clinicaltrials.gov) - P1/2 | N=30 | Completed | Sponsor: Advagene Biopharma Co. Ltd. | Phase classification: P2a ➔ P1/2 | Trial completion date: May 2023 ➔ Dec 2023 | Trial primary completion date: May 2023 ➔ Oct 2023

Phase classification • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • IL6

AD17002 Treating Poorly Controlled, Moderate to Severe Eosinophilic Asthma (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Advagene Biopharma Co. Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: May 2024 ➔ Sep 2024 | Trial primary completion date: Mar 2024 ➔ Jun 2024

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

Evaluating the Safety and Efficacy of AD17002 Intranasal Spray in Treating Participants With Mild to Moderate COVID-19 (clinicaltrials.gov) - P2/3 | N=180 | Recruiting | Sponsor: Advagene Biopharma Co. Ltd. | Trial completion date: Dec 2023 ➔ Mar 2025 | Trial primary completion date: Dec 2023 ➔ Oct 2024

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

AD17002 Treating Poorly Controlled, Moderate to Severe Eosinophilic Asthma (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Advagene Biopharma Co. Ltd.

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluating Safety, Tolerability, and Potential Efficacy of Intranasal AD17002 in Adults With Mild to Moderate COVID-19 (clinicaltrials.gov) - P2a | N=30 | Completed | Sponsor: Advagene Biopharma Co. Ltd. | Recruiting ➔ Completed | Trial primary completion date: Oct 2022 ➔ May 2023

Trial completion • Trial primary completion date • Immune Modulation • Infectious Disease • Novel Coronavirus Disease

Evaluating the Safety and Efficacy of AD17002 Intranasal Spray in Treating Participants With Mild to Moderate COVID-19 (clinicaltrials.gov) - P2/3 | N=180 | Recruiting | Sponsor: Advagene Biopharma Co. Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2023 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Enrollment open • Trial completion date • Trial primary completion date • Immune Modulation • Infectious Disease • Novel Coronavirus Disease

Evaluating the Safety and Efficacy of AD17002 Intranasal Spray in Treating Participants With Mild to Moderate COVID-19 (clinicaltrials.gov) - P2/3 | N=180 | Not yet recruiting | Sponsor: Advagene Biopharma Co. Ltd.

New P2/3 trial • Immune Modulation • Infectious Disease • Novel Coronavirus Disease

Evaluating Safety, Tolerability, and Potential Efficacy of Intranasal AD17002 in Adults With Mild COVID-19 (clinicaltrials.gov) - P2a | N=30 | Recruiting | Sponsor: Advagene Biopharma Co. Ltd. | Trial completion date: Apr 2022 ➔ Feb 2023 | Initiation date: Dec 2021 ➔ Mar 2022 | Trial primary completion date: Apr 2022 ➔ Oct 2022

Trial completion date • Trial initiation date • Trial primary completion date • Immune Modulation • Infectious Disease • Novel Coronavirus Disease

Evaluating Safety, Tolerability, and Potential Efficacy of Intranasal AD17002 in Adults With Mild COVID-19 (clinicaltrials.gov) - P2a; N=30; Recruiting; Sponsor: Advagene Biopharma Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Immune Modulation • Infectious Disease • Novel Coronavirus Disease • PCR

Evaluating Safety, Tolerability, and Potential Efficacy of Intranasal AD17002 in Adults With Mild COVID-19 (clinicaltrials.gov) - P2a; N=30; Not yet recruiting; Sponsor: Advagene Biopharma Co. Ltd.

Clinical • New P2a trial • Immune Modulation • Infectious Disease • Novel Coronavirus Disease

Tolerability and Potential Efficacy of LTh(αΚ) in Subjects With Allergic Rhinitis (clinicaltrials.gov) - P1/2; N=48; Completed; Sponsor: Advagene Biopharma Co. Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Allergic Rhinitis • Immunology

Tolerability and Potential Efficacy of LTh(αΚ) in Subjects With Allergic Rhinitis (clinicaltrials.gov) - P1/2; N=48; Active, not recruiting; Sponsor: Advagene Biopharma Co. Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Allergic Rhinitis • Immunology

Tolerability and Potential Efficacy of LTh(αΚ) in Subjects With Allergic Rhinitis (clinicaltrials.gov) - P1/2; N=48; Recruiting; Sponsor: Advagene Biopharma Co. Ltd.

New P1/2 trial