Pipeline

Advancing a New Wave of Inhaled Therapies

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

A Diverse Pipeline Targeting Respiratory And Chronic Diseases

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

AER-901 - Inhaled Imatinib

Pulmonary Arterial Hypertension (PAH)
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
Phase 1 Completion

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

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

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.

Inhaled Human Insulin for Type 1 and 2 Diabetes

We developed a soft mist inhaled human insulin for the treatment of Type 1 and 2 diabetes. Clinical data based on our five Phase 1/2a studies demonstrated AER-501 has:

  • Faster onset and similar profile when compared to lispro.
  • Intra and inter-subject variability similar to injections.
  • Minimal to no cough following inhalation.

These clinical studies also demonstrated the AFINA drop dispenser enables fast, accurate and precise dose loading at a low cost with low drop weight variability of 3-4%¹.

How It Works

Each administration event requires one to load the device only once, using 1–5 drops (55 to 275 microliters) allowing for fast administrations. The drop dispenser offers a strong, sterile microbial barrier to reduce contamination of the drug before administration while maintaining the stability of the formulations for long periods of time.

Partnership Opportunities

We plan to have an end-of-Phase 2 meeting with the FDA and then seek a partner to progress AER-501 into registration studies.

Inhaled Glucagon-like Peptide-1 (GLP-1) Analog

We have completed toxicology studies for AER-601. The product candidate is ready to advance into Phase 1 studies.

AER-601 is delivered via our AFINA smart inhaler to help individuals with type 2 diabetes (T2D) achieve a superior level of postprandial glucose control and avoid undesirable gastrointestinal side effects associated with injectable treatments. The smart inhaler enables pulsatile and flexible delivery of lower GLP-1 dosing:

  • Flexible, convenient dosing
  • Improved safety profile

Why AER-601?

A large number of individuals with T2D experience postprandial hyperglycemia (PPH - hyperglycemia after meals) despite the current standard of care. Current treatment guidelines for T2D recommend GLP-1 as one of the non-insulin medications to control both basal and postprandial hyperglycemia. Approved therapies are mainly effective in controlling only the basal component, creating a significant unmet need for an alternative to address postprandial hyperglycemia. The inability to control PPH beyond the first decade after diagnosis leads to long-term consequences, including weight gain on insulin therapy, an inability to achieve HbA1c goals over time, and increased microvascular complications. ² ³ ⁴

Precision Inhaled Drug Delivery

We are leveraging our proprietary inhalation technology, the AFINA Inhaler, which combines novel drug aerosol formulations and cutting-edge technology, to advance our diverse pipeline of inhaled therapies to treat severe respiratory and chronic diseases.

About Our Technology
  1. Dance BioPharm. “Multi-Site Investigation of Dance 501 Dosage Form Drop Dispenser- Actuations to Priming, Drop Accuracy and Repeatability.” 20 November 2014.
  2. International Diabetes Federation. DF Diabetes Atlas- 8th Edition. https://diabetesatlas.org/. Accessed July 24, 2019.
  3. Ikeda, H., Uzui, H., Morishita, T., et al. (2015). Effect of postprandial hyperglycemia on coronary flow reserve in patients with impaired glucose tolerance and type 2 diabetes mellitus. Diabetes and Vascular Disease Research, 12(6), 405–410. doi: 10.1177/1479164115597866
  4. Akturk, H. K., Rewers, A., Joseph, H., et al. (2018). Possible Ways to Improve Postprandial Glucose Control in Type 1 Diabetes. Diabetes Technology & Therapeutics, 20(S2). doi: 10.1089/dia.2018.0114