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Dance Biopharm Presents Encouraging Data from Phase 2 Clinical Trial of Dance 501 Inhaled Insulin Therapy at American Diabetes Association Meeting

– Faster onset of action shown for Dance 501 compared to subcutaneous
injection of insulin lispro –

– No changes in lung function and no cough observed in patients
receiving inhaled Dance 501 –

SAN FRANCISCO–(BUSINESS WIRE)–Dance
Biopharm Holdings, Inc.
, a privately-held clinical stage biopharma
company focused on the development of novel soft mist inhalable
formulations of biologics for people living with chronic diseases, today
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 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.

“Our presentations at ADA underscore Dance’s ongoing commitment to
develop 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. 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 and Results

This Phase 2 trial, 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.

The poster titled, Dance 501 Inhaled Human Insulin (INH): Linear Dose
Response, Earlier Onset of Action, and Higher Early Effect than s.c.
Insulin Lispro (LIS), may be
found on the Dance Biopharm website
at:
https://www.dancebiopharm.com/dance-501.

About Dance Biopharm

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. For more information, please visit http://dancebiopharm.com.

FORWARD-LOOKING STATEMENTS

All statements other than statements of historical fact included in this
press release are forward-looking statements that are subject to certain
risks, trends and uncertainties that could cause actual results and
achievements to differ materially from those expressed in such
statements. We have based these forward-looking statements upon
information available to management of Dance as of the date of this
release and management’s expectations and projections about certain
future events. It is possible that the assumptions made by management
for purposes of such statements may not materialize. Actual results may
differ materially from those projected or implied in any forward-looking
statements. Such statements may involve risks and uncertainties,
including but not limited to those relating to our limited operating
history, our ability to successfully develop product candidates,
including Dance 501, the cost and uncertainty of obtaining regulatory
approvals, our ability to bring product candidates, including Dance 501,
to multiple markets and our ability to develop inhaled formulations of
other medicines.

Contacts

Investors
Robert H. Uhl
Managing Director
Westwicke IR
858-356-5932
[email protected]

Media
Jim Heins
Senior Vice President
Westwicke PR
203-682-8251
[email protected]

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