We have the intellectual property and expertise to create formulations that are lung friendly and stable. Our AER 501, inhaled human insulin, and AER 601, inhaled fast acting GLP-1, are preservative free solutions that include excipients natural to the lung. Each of our product formulations and respective dispensers will be assigned novel intellectual property.
INHALED HUMAN INSULIN
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 Dance 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 Dance-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.
INHALED SHORT ACTING GLUCAGON
LIKE PEPTIDE (GLP-1) ANALOG
Inhaled Short Acting Glucagon Like Peptide (GLP-1) Analog
We have formulated a short-acting GLP-1 analog, Aerami 601, for delivery 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
HORMONE (PTH) FOR
Inhaled Parathyroid Hormone (PTH) for Hypoparathyroidism
We are developing an inhaled PTH, Aerami 701, to restore physiological levels of PTH by allowing for a convenient inhaled delivery of PTH in pulsatile treatments throughout the day. Hypoparathyroidism is a rare disease characterized by deficient or absent parathyroid hormone often caused by damage to the gland during surgery.
Conventional treatments for hypoparathyroidism are inadequate and can lead to hypocalcemia, hypercalcemia and hypercalciuria (short-term); impaired renal function and extra skeletal calcifications (long-term). There is evidence that an ideal PTH drug delivery system that allows for pulsatile administration, such as an inhaled option, could better mimic the physiological tonic, circadian, and pulsatile profile of PTH leading to higher efficacy of the treatment5,6.
INHALED HUMAN GROWTH
HORMONE (HGH) FOR GROWTH
Inhaled Human Growth Hormone (hGH) for Growth Hormone Disorder
We are advancing an inhalable HGH, Aerami 801, to provide a better patient experience and encourage adherence and compliance, which can lead to improved patient outcomes. HGH deficiency is a rare condition that abnormally slows growth in children, leading to later health complications.
HGH is approved by the FDA for use in growth hormone deficiency. This is administered typically via daily injections although severe cases might need more frequent dosing. Poor adherence with daily injectable HGH is associated with impaired quality of life7. Frequent pulsatile administration of HGH would better mimic physiological release and provide ideal efficacy for patients with HGH deficiency.
- Dance BioPharm. “Multi-Site Investigation of Dance 501 Dosage Form Drop Dispenser- Actuations to Priming, Drop Accuracy and Repeatability.” 20 November 2014.
- International Diabetes Federation. DF Diabetes Atlas- 8th Edition. https://diabetesatlas.org/. Accessed July 24, 2019.
- 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
- 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
- Tay, D., Cremers S., and Bilezikian, J.P. (2017). Optimal Dosing and Delivery of Parathyroid Hormone and Its Analogues for Osteoporosis and Hypoparathyroidism – Translating the Pharmacology. British Journal of Clinical Pharmacology, 84 (2), 252-67. doi:10.1111/bcp.13455
- Dang, M., Koh, A.J., Danciu, T., Mccauley, L.K. and Ma, PX. ((2016). Preprogrammed Long-Term Systemic Pulsatile Delivery of Parathyroid Hormone to Strengthen Bone. Advanced Healthcare Materials, 6 (3). doi: 1600901. doi:10.1002/adhm.201600901.
- Cutfield W.S., Derraik, J.G.B, Reid, K., et al. (2011). Non-Compliance with Growth Hormone Treatment in Children Is Common and Impairs Linear Growth. PLoS ONE, 6(1): e1622