DURHAM – In the not very distant future, Type 2 diabetes patients may have an option to inhale insulin that acts faster and lasts longer than Lilly’s injected insulin Humalog or its generic, lispro, the current standard treatment.
Durham-based Aerami Therapeutics, which changed its name from Dance Biopharm Holdings Inc. on Wednesday, reports that data from its Phase 2 clinical study of Dance 501, a novel gentle mist formulation of human insulin administered with its smart inhaler, showed it had comparable glucodynamic properties to injected insulin, but delivered a faster onset of action. It had no safety issues in the trial.
Anne Whitaker, CEO and director of Dance, told the Biotech Center that “In five clinical trials for Type 2 or Type 1 diabetes, we have consistently seen that it is faster on and slower off.” That produces a “nice, healthy insulin profile, similar to the way a healthy person’s pancreas responds to a meal,” and the effect is sustained until the next meal.
“These encouraging study results demonstrate the potential of Dance 501 inhaler to offer a clinically meaningful benefit over rapid-acting insulin injections for patients with Type 2 diabetes, while also providing a more comfortable patient experience,” said Melissa Rhodes, Ph.D., chief development officer of Dance, the in the results announcement.
“This study also further validates our smart inhaler’s ability to deliver an optimal and precise dose of inhaled therapies through the lungs. A number of diseases could benefit from the frequent pulsating administration afforded by an inhaled delivery option, so we are exploring inhaled therapies beyond human insulin where our platform could achieve better treatment efficiency.”
Dance has the data to initiate Phase 3 trial
Founded in 2010 in the Bay Area of California by the device inventor, John Patton, Dance Biopharm moved its headquarters to Durham in April 2019. It’s located in the same building as Pappas Ventures, although it has no other relationship with Pappas. Dance has four employees in Durham, three in New York, and six in California.
The company raised $92 million to date, including $20.5 million in the first quarter of 2019. Investors include Molex Ventures, a subsidiary of Koch Industries, and institutional investors based in Hong Kong and New York.
“We have the data now to initiate a Phase 3 registration study,” Whitaker said. “We’re going to pursue partnering to take us forward in Phase 3 and commercialization. One partner, Dongbao, will pay 55 percent of development costs in China, which is projected to have a number of diabetes patients in the next decade that exceeds the entire population of the United States.”
Depending on registration, the company hopes to launch one-third of its efforts in China, one-third in the U.S., and one-third in Europe.
The company expects to have two more inhaler-related products in the clinic by 2020. Its glucagon-like peptide-1 (GLP-1) works differently than insulin for Type 2 diabetes patients to reduce blood sugar, but also helps them lose weight. Obesity is a risk factor for Type 2 diabetics, and some patients who lose enough weight, no longer need treatment for the disease.
It also has a human growth hormone product in the works. Its inhaler technology has won numerous patents and it is filing new applications in U.S., EU, China, Brazil, Russia, India, Mexico and Canada for its various pipeline products.
Whitaker said the company will build out its organization in NC as it moves Dance 501 along and continues development of its other products. “Our aim is to make living with chronic diseases easier,” she said.
(C) N.C. Biotech Center