Dance Biopharm recently presented phase 2 trial results for its inhaled preservative-free human insulin, Dance 501, for the treatment of Type 2 diabetes at the 79th Scientific Sessions of the American Diabetes Association, in San Francisco, Calif.
The results showed a faster onset of action for Dance 501 inhaled insulin compared to comparable doses of subcutaneously administered insulin lispro.
“Our presentations at ADA underscore Dance’s ongoing commitment to developing innovative, patient-centric inhaled therapies that lead to improved health outcomes for people living with chronic diseases like diabetes,” said Anne Whitaker, chief executive officer of Dance Biopharm.
“We are excited to present new data that further reinforce the potential of Dance 501, our inhaled preservative free human insulin, as an alternative treatment to injectable insulin for diabetes,” she added, “These data demonstrate the excellent performance of our soft mist inhaler platform and emboldens us to rapidly progress the development of our pipeline of novel, soft mist biologics as treatments for severe and chronic diseases.”
Trial Design
The phase 2 trial, known as Samba 04, was designed as a randomized, crossover, open-label, active-comparator-controlled study that enrolled 24 subjects with Type 2 diabetes currently receiving insulin therapy or metformin.
Each patient received 3 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 6 doses over 6 visits that occurred 3 to 17 days apart. Insulin action was measured using the automated glucose clamp method over a 10-hour period following dosing.
Key findings presented from the trial include the following:
1. Dance 501 showed comparable pharmacodynamic properties and more rapid onset of action compared to insulin lispro.
2. Greater action in the first hour of administration for inhaled human insulin (INH) compared to lispro at all three doses with median relative differences of 107%, 57% and 45%, (p < 0.05).
3. Time to maximum insulin action was comparable for each dose level.
4. 30 of 31 adverse events were observed and rated as mild to moderate, 13 reported for INH and 18 for lispro. One serious adverse event was reported after lispro dosing but was deemed unlikely related to test medication.
5. Dance 501 showed good tolerability overall, no cough was observed with INH dosing, and no changes in lung function were observed.
Dance Biopharm.
Featured Image: Dance soft mist inhaler. Courtesy: Dance Biopharm.
Source:
- Dance Biopharm. (2019, June 8). Dance Biopharm Presents Encouraging Data from Phase 2 Clinical Trial of Dance 501 Inhaled Insulin Therapy at American Diabetes Association Meeting. Retrieved June 14, 2019, from https://www.businesswire.com/news/home/20190608005016/en