fexlamose (AER-01) / Aer Therap - LARVOL DELTA

Safety and Tolerability of a Novel Inhaled Thiol-Saccharide Mucolytic (Fexlamose, MUC-031) in Healthy Volunteers (ATS 2025) - "Fexlamose (previously MUC-031 and AER-01) is a novel thiol-modified carbohydrate drug designed for inhaled delivery, that is more potent and has a faster onset of action than N-acetylcysteine (3). Inhaled fexlamose is well-tolerated by healthy human subjects. These data support further study of the safety and efficacy of fexlamose in patients with muco-obstructive lung disease, including the ongoing proof of concept study in patients with COPD. References: 1."

Clinical • Asthma • Chronic Obstructive Pulmonary Disease • Cough • Hematological Disorders • Immunology • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases

Aer Therapeutics Announces First Patient Dosed in Phase 2 Clinical Trial of Fexlamose in Chronic Obstructive Pulmonary Disease (GlobeNewswire) - "Aer Therapeutics...announced today that the first patient has been dosed in its Phase 2a proof-of-concept ('POC') clinical study of fexlamose (formerly 'AER-01') in Chronic Obstructive Pulmonary Disease ('COPD'). The Phase 2a POC study ('AER-01-002') is a randomized, double-blind, placebo controlled, parallel group study of fexlamose given once daily for 28 days to patients with COPD. Aer is utilizing a novel approach to identify and treat mucus plug-high COPD patients. Specifically, AER-01-002 will enroll 100 patients with moderate to severe COPD who are mucus plug-high....AER-01-002 is being conducted in clinical sites in Australia and New Zealand, with plans to expand to the United Kingdom. Top-line data are expected in January 2026."

P2a data • Trial status • Chronic Obstructive Pulmonary Disease

AER-01-002: A Study to Investigate Using Inhaled Fexlamose to Treat Adult Participants Who Have Moderate to Severe COPD (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Aer Therapeutics

New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Single and Multiple Ascending Dose Study of AER-01 (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Aer Therapeutics | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Single and Multiple Ascending Dose Study of AER-01 (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Aer Therapeutics

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Aer Therapeutics Raises $36M for Novel Approach to COPD (BioSpace) - "Human airways have three areas of pathological problems, Fahy told BioSpace....Delivering this agent via the airway is the key with AER-01, Fahy explained. Current drugs marketed to break up mucus have limited efficacy because when taken orally, sufficient concentrations will not reach the obstructed areas through the bloodstream to break up the plugs. Fahy said the principle of using an oral medication to treat airway mucus plugs is 'doomed at the door.'"

Media quote

Aer Therapeutics Closes $36 Million Series A to Advance Development of AER-01, an Innovative Mucolytic for the Treatment of Lung Diseases (PRNewswire) - "Aer Therapeutics...today announced the closing of a $36 million Series A financing. Funding was received from a syndicate of premier life science industry investors, including Canaan, OrbiMed, and Hatteras Venture Partners....Aer Therapeutics plans to initiate a first-in-human Phase 1 clinical trial of AER-01 in mid-2023."

Financing • New P1 trial • Chronic Obstructive Pulmonary Disease • Respiratory Diseases