Pipeline

Advancing a New Wave of Inhaled Therapies

Aerami Therapeutics is developing differentiated inhaled therapies for the treatment of cardiopulmonary conditions. Our novel programs provide of a potential alternative to routine injections, which allows for improved efficacy and a better patient experience.

Focused Pipeline Targeting Serious and Rare Cardiopulmonary Conditions

Development Program Formulation & Device Feasibility IND Enabling Phase 1 Phase 2 Phase 3 Next Key Milestone Target

AER-901 - Inhaled Imatinib

Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
COMPLETED               COMPLETED               COMPLETED
Formulation & Device Feasibility Phase complete
IND Enabling Phase complete
Phase 1 Phase in progress
Phase 2a Phase not started
Phase 3 Phase not started
Progression into Phase 2

AER-901 - Inhaled Imatinib

Pulmonary Arterial Hypertension (PAH)
COMPLETED               COMPLETED               COMPLETED
Formulation & Device Feasibility Phase complete
IND Enabling Phase complete
Phase 1 Phase in progress
Phase 2a Phase not started
Phase 3 Phase not started
Progression into Phase 2
Legacy Programs

AER-601 - Soft-mist Inhaled Exenatide

Post-prandial hyperglycemia in T2D
TOXICOLOGY STUDIES COMPLETED
Formulation & Device Feasibility Phase complete
IND Enabling Phase in progress
Phase 1 Phase not started
Phase 2a Phase not started
Phase 3 Phase not started
Progression into Phase 1/2a

AER-501 - Soft-mist Inhaled Insulin

Improved Glycemic Control in Type 1 and 2 Diabetes (T1D & T2D)
5 PHASE 1/2a STUDIES COMPLETED
Formulation & Device Feasibility Phase complete
IND Enabling Phase complete
Phase 1 Phase complete
Phase 2a Phase in progress
Phase 3 Phase not started
Progression into Phase 3

Inhaled Imatinib for PAH

We have advanced inhaled imatinib, AER-901, into the clinic for the treatment of patients with pulmonary arterial hypertension (PAH). The Phase 1 trial is currently underway.

About Pulmonary Arterial Hypertension

PAH is a devastating disease for which there is no cure. The disease causes blood vessels in the lungs to become narrowed, blocked, or destroyed. The damage slows blood flow through the lungs, eventually causing the heart muscles to become weak and fail.

Our Goal with AER-901

Oral imatinib, a tyrosine kinase inhibitor, has been used in a Phase 3 clinical trial to treat PAH. Oral imatinib demonstrated statistically significant improvement in pulmonary hemodynamics and physical capacity in PAH patients in the Phase 3 IMPRES study. However, the indication was not pursued because of substantial adverse events seen in the trial. By delivering an inhaled imatinib directly to the site of the disease, we believe that we will be able to significantly reduce the dose necessary to achieve therapeutic benefit and avoid the significant adverse events seen with oral imatinib.