Dance Biopharm Holdings, Inc.

Pipeline

Dance 501: A Patient-Friendly Approach

Dance-501 is an investigational pocket-sized inhaler device, with an insulin container, that is designed to control prandial blood sugar in adults with diabetes, eliminating the need for injections.

The insulin formulation used in Dance-501 is packaged separately in a special insulin container. A few drops of liquid can be accurately dispensed into the reservoir on top of the device for dosing at mealtime.

The Dance-501 insulin inhaler is based on vibrating mesh micropump technology developed and commercialized by Aerogen. We chose to develop a liquid formulation of insulin, instead of a dry powder, to lower manufacturing costs, eliminate cough and facilitate ease-of-use.

Clinical Studies

We have received positive clinical results across 5 trials

Phase I/II Study - Samba-01

This study consisted of randomized, active controlled trials that investigated the Pharmacokinetic (PK) profile of a single low dose of inhaled insulin in 12 patients with Type 1 diabetes.

The study was completed in 2013.

Phase II Study - Samba-02

This study consisted of randomized, open label, active controlled trial investigating the PK and Pharmacodynamic (PD) profiles of three dose levels of inhaled insulin (9, 18 and 27 inhaled units) in 23 patients with Type 2 diabetes.

The study was completed in 2014.

Phase I/II Study - Samba-03

Type 1 dose response & variability vs injected with commercial formulation & device.

Complete final report in Q3 2019.

Phase II Study - Samba-04

Type 2 dose response & variability vs injected with commercial formulation & device.

Data to be presented at ADA June 2019.

Phase I/II Study - Samba-V

Variability in Type 1 Patients

Complete final report in Q3 2019.

Study Highlights

  • Intra and inter-subject variability similar to injections
  • PK profile: faster onset and longer duration than Humalog
  • Dose linearity
  • Minimal to no cough
  • Data enables dose optimization for upcoming final PK/PD studies Phase 3 studies