Dance Biopharm Holdings Inc.

Dance 501:
A Patient-Friendly Approach

A needle-free, pain-free, tasteless insulin delivery system

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 received positive clinical results across two 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.

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 and Phase 3 studies

Development Pipeline

Dance-501 has completed Phase 2 clinical trials and is in preparation for pivotal development.

Candidate & Indication Development Stage
DANCE-501 Diabetes
Preclinical Phase complete
Phase 1
Phase 1 Phase complete
Phase 2
Phase 2 Phase in progress
Phase 2*
Phase 2* Phase not started
Phase 3
Phase 3 Phase not started
Market Phase not started
*Final short PK/PD studies in Type 1, Type 2, Asthma and Chronic Obstructive Pulmonary Disease (COPD) patients.