Does digital plus drug equal more? That’s a big question in pharma these days—and it's what MannKind and One Drop are hoping to prove. The companies have teamed up on a clinical trial testing the drugmaker's inhaled insulin Afrezza alongside One Drop’s digital diabetes management platform.
The A-One study will randomize qualified people with type 2 diabetes into two treatment groups. One group will use the One Drop platform alone, while the other will use Afrezza along with One Drop. The One Drop program includes its mobile app, an expert coaching service and its Bluetooth custom glucose monitoring meter called Chrome, along with test strips.
“The idea is medication adherence as a way to stay healthy can happen in a better way in an empowered, digital self-care platform like One Drop,” said Jeff Dachis, CEO and founder of One Drop. “And when we pair it with a pharma intervention, we think we can achieve even better outcomes than we do alone or when the pharma product is taken alone.”
The plan is to evaluate data from the six-month study and publish the results, MannKind chief medical officer Dr. Raymond Urbanski said, with an eye to presenting them at the American Diabetes Association's Scientific Sessions next year.
Urbanski said the One Drop platform extends the concept of disease management in an elegant and easy-to-use technological format. For Afrezza’s atypical inhaled delivery approach, the A-One study is an opportunity to gather information on how patients use, dose and titrate Afrezza within the One Drop system, he said.
MannKind is hoping to update Afrezza's label with claims that could help it stand out in the competitive fast-acting insulin category—for instance, that it works faster and leaves the body more quickly. Urbanksi said the company expects an FDA decision on that update in September.
One Drop’s Dachis, when asked whether the digital company plans to work with other diabetes drugmakers, said “yes,” but declined to provide any additional details.
Afrezza, the only inhaled insulin now on the market, has struggled in the diabetes market. MannKind initially struck a marketing deal with Sanofi for its market launch, but after less-than-spectacular sales, the French drugmaker dropped out of the deal. MannKind took control of the drug's marketing last year.
While Sanofi launched a 2015 mainstream DTC campaign for Afrezza, MannKind has focused more on informing patients and doctors by beefing up its social media platforms, along with presenting at medical conferences and going directly to healthcare providers.
A MannKind-created Afrezza TV commercial has aired several times this summer during the Discovery Life reality diabetes show “Reversed,” a show it sponsors, and can also be viewed online.
The One Drop partnership was announced the same day MannKind reported second-quarter results (PDF) of $1.5 million in sales for Afrezza, and an overall $35.3 million loss for the quarter.
Dachis, who has type 1 diabetes and uses Afrezza, said when asked about the drug's slow uptake, “I would argue that for the amount of time they’ve been in market under their own control, they’ve seen decent uptake. It takes a while to build a system. … I like the product a lot.” He said he thinks the quick-acting, quick-exit formulation—as well as no need for needles—offers big benefits for both type 1 and type 2 patients.