Pipeline

501
Inhaled Human Insulin

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

Clinical studies to date on AER-501 proved the AFINA drop dispenser enables fast, accurate and precise dose loading at a low cost with low drop weight variability of 3-4%¹. Each administration event requires 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.

We are seeking partners to progress AER-501 into registration studies.

601
Inhaled Short Acting Glucagon Like Peptide (GLP-1) Analog

We have completed seven and twenty-eight day toxicology studies for AER-601. The product candidate is ready to go into Phase 1 studies.

AER-601 is delivered via our smart inhaler prior to meals, to help type 2 diabetes (T2D) patients 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

A large number of patients with T2D experience postprandial hyperglycemia (PPH- hyperglycemia after meals) despite the current standard of care. Current treatment guidelines for T2D recommend GLP-1 starting from dual-therapy 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

AER-601 is available to license in all geographies.

901
Inhaled Imatinib

We are advancing inhaled imatinib, AER-901, into the clinic for treatment of patients with pulmonary arterial hypertension (PAH). We are targeting the start of a Phase 1 trial in the second half of 2020.

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.

Oral imatinib, a tyrosine kinase inhibitor used to treat certain types of cancers, has been used in a Phase 3 clinical trial to treat PAH. Although oral imatinib demonstrated statistically significant improvement in pulmonary hemodynamics and physical capacity in PAH patients in the Phase 3 IMPRES study, 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.