Insights

A Promising New Frontier in Patient Adherence Lies in Inhaled Biologic

By Anne Whitaker, Director and Chief Executive Officer, Dance Biopharm Holdings, Inc.

To a small child or even a grown adult, the concept of sticking oneself with needles, especially multiple times a day, to administer medication for chronic health conditions such as diabetes and growth hormone deficiency is enough to make anyone squeamish.   Make no bones about it: injections hurt.  But even more painful are the delayed or missed doses of treatment that can lead to significant health consequences and drive up healthcare expenses.

Lack of medication adherence has proven to be a persistent and costly challenge.  A number of studies show that only half of the patients in the United States take their medication as prescribed, costing approximately $290 billion annually.   Combine that fact with a growing global epidemic like diabetes, which affects an estimated 425 million people worldwide and accounts for at least $727 billion annually in healthcare expenditures, and this concern multiplies exponentially.

Forging a Novel Path to an Age-Old Problem

Traditionally, injected insulin has been the gold standard for treatment of diabetes.  I’ve personally known the devastating effects of the disease, as several of my relatives and family friends lost their limbs – and lives – to diabetes complications.   As a Southern girl, I grew up in what was referred to as the “Sugar Belt” in Alabama and spent my life resisting the temptations of my genetic predisposition and skirting the grip of diabetes.  In fact, my passion led me to make a career of it in my adulthood, where I’ve spent 27 years in the industry.  I began my journey as a metabolic specialty sales rep in Big Pharma, which later led to executive positions where I steered branded diabetes pharmaceuticals across all stages of the product lifecycle. 

My previous experiences with GlaxoSmithKline and with Sanofi managing the commercialization and sales of insulin treatments for diabetes were eye-opening.  I witnessed first-hand the dangerously low rate of medication adherence with Type 2 patients and the call to pursue an alternative way to deliver insulin became a battle cry. 

I saw the S.O.S. on the horizon and turned my passion into a mission as I recently took the helm as CEO of Dance Biopharm.   Working alongside one the original pioneers of inhaled insulin, Dr. John Patton, offered an opportunity for a collaboration that I believe will revolutionize the industry. There’s a promising potential for how we can transform the way that not just insulin, but other medications, can be delivered to improve patient adherence, drive better health outcomes and lower healthcare costs.

A Compelling Case for Next Generation Drug Delivery Design

Inhaled biologics may be a start to improving medication adherence, but it’s not enough.  There has to be a better, faster and easier way for patients to consume the treatment, and the answer lies in the design of the drug delivery system itself.  Inhaled insulin, for example, is not an entirely new concept.  There are two powder inhaled insulin formulations that have come on the U.S. market; however only one remains available today and has limited use.  Unlike our Dance liquid insulin, the powder insulins are often costly and challenging to manufacture.  Dosing with powder insulin can also be a time consuming and cumbersome process for patients.  That’s because patients are supplied their dose in multiple blister packs or cartridges and have to use several to get to their right dose.  Finally, the powder insulins also have the potential side effect of coughing which, in some cases, causes the patient to stop using the product.   

At Dance Biopharm, we’re working on developing a new generation of inhaled insulin delivered via a small, handheld soft mist inhaler.  Our investigational product, Dance 501, will be heading into Phase III clinical trials later this year for type 2 diabetes patients.  Dance 501 consists of a high purity liquid formulation of recombinant human insulin stored in a dispenser for administration with a small handheld electronic inhaler. 

The pocket-sized electronic inhalation device utilizes a patented vibrating mesh technology designed to produce consistently sized particles of liquid insulin in the form of a soft mist.  This allows the efficient and uniform delivery of insulin into the lungs in a few breaths.  Using a liquid formulation instead of a dry powder also reduces manufacturing costs, helps to eliminate the risk of cough and supports ease of use and adherence.

While inhaled insulin delivery offers a potentially promising needle-free alternative and an easier and more convenient for patients to control their blood glucose, I’m especially optimistic about the potential that this novel drug delivery approach has beyond diabetes management.  At Dance, we’re looking at other inhaled biologic formulations for the treatment of various metabolic diseases such as obesity, as well as human growth disorders in pediatric and adolescent patients, parathyroid conditions and other specialty disorders.  

Making the Connection to Empower Patients and Physicians

Finally, I’m really excited about taking our inhalation device a step further by integrating connectivity.  Using connectivity in a drug delivery device, coupled with an app, enables patients and healthcare professionals to track when patients take their medication and the dosage amount.   Connectivity provides opportunities to support patients through reminders, incentives and peer communities to improve adherence, disease management and, ideally, outcomes.  We’re working closely with our partner, Phillips Medisize, a Molex company, as the contract manufacturer for our soft mist inhaler device and also to build connectivity into this device while Dance 501 moves forward into late stage clinical trials.

The future looks bright for Dance as we kick off 2019.  With a validated inhaled biologic platform and a promising pipeline, we aim to tackle conditions where there are significant unmet medical needs, as well as to help improve medication adherence and outcomes by minimizing the serious symptoms, side effects and associated costs that can occur with delayed or improper management.