Policy & Regulation
Dance Biopharm Presents Data from Phase 2 Clinical Trial of Dance 501 Inhaled Insulin Therapy at American Diabetes Association Meeting
11 June 2019 - - US-based biopharma company Dance Biopharm Holdings, Inc has presented Phase 2 Samba 04 clinical trial results for its inhaled preservative-free human insulin, Dance 501, for the treatment of type 2 diabetes, the company said.
The results showed a faster onset of action for Dance 501 inhaled insulin compared to comparable doses of subcutaneously administered insulin lispro.
These findings are being presented at the 79th Scientific Sessions of the American Diabetes Association (#ADA2019), being held in San Francisco.
This Phase 2 trial, Samba 04, was designed as a randomised, crossover, open label, active-comparator-controlled study that enrolled 24 subjects with type 2 diabetes currently receiving insulin therapy or metformin.
Each patient received three doses of inhaled Dance 501 and 3 doses of subcutaneous insulin lispro under medical supervision or administration.
The inhalation device is a small hand held electronic aerosol device with a vibrating mesh micro-pump technology that transforms the liquid insulin formulation into a mist upon patient inhalation.
Doses administered were 12, 24 and 48 U for both Dance 501 (assuming 13% delivery efficiency) and lispro.
Each patient received all six doses over six visits that occurred three to 17 days apart. Insulin action was measured using the automated glucose clamp method over a 10-hour period following dosing.
Dance Biopharm is a private company focused on developing novel inhaled formulations of biologics to treat severe and chronic diseases.
The company's novel inhalation delivery technology platform may be utilized with liquid formulations of biologics with the goal of providing effective and convenient treatment options to patients along with wireless connectivity to improve disease management.
Dance, headquartered in the San Francisco Bay Area, was founded by John Patton, Ph.D., who has over 25 years of experience developing numerous inhaled therapies.