Biodel Advances Ultra-Rapid-Acting Concentrated Insulin Formulation Into
Top Line Data Expected in First Quarter of 2014
DANBURY, Conn., Nov. 7, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD)
today announced the initiation of a Phase 1 clinical trial under its existing
U.S. Investigational New Drug Application, as part of the development program
for concentrated insulin candidate BIOD-531. BIOD-531 is a proprietary novel
formulation of concentrated recombinant human insulin (RHI) with a unique
time-action profile to address the growing population of severely insulin
resistant type 2 diabetes patients and the existing population of patients
currently using premixed insulins to manage both prandial and basal glucose
control requirements with a single injection. The company anticipates top line
data in the first calendar quarter of 2014.
Chief executive officer Dr. Errol De Souza said: "BIOD-531's
ultra-rapid-acting onset and basal duration profile, coupled with its high
concentration, could offer diabetes patients and medical practitioners a novel
tool to improve prandial coverage, while maintaining adequate basal coverage,
in both insulin resistant patients and patients who use premixed insulins."
The Study is a four-way cross-over Phase 1 clinical trial in which the
pharmacokinetic, pharmacodynamic and injection site toleration profiles of
BIOD-531 will be evaluated and compared to Humulin^® R, U-500 and to Humalog^®
prandial/basal premixed insulin. Twelve volunteers will receive single
injections of each insulin on separate days in a randomized treatment
sequence. The identity of each study drug will be blinded at the time of the
injection. After each test injection, volunteers will undergo euglycemic clamp
studies to determine the pharmacodynamic profile of the test insulin
formulation. On two of the test days, BIOD-531 and Humulin R, U-500 will be
administered at doses of 1.0 unit/kg, which is the range used by patients with
type 2 diabetes and severe insulin resistance. On the other two days of the 4
period Study, BIOD-531 and Humalog 75/25 premixed insulin will be administered
at a dose of 0.5 units/kg. This dose reflects that which might be used by
patients with moderate degrees of insulin resistance who use premixes.
Biodel's concentrated insulin candidate BIOD-531 contains 400 units per
milliliter (U-400) of RHI formulated with EDTA, citrate and magnesium sulfate.
In preclinical studies in diabetic swine, BIOD-531 demonstrated a more rapid
rate of absorption and onset of action than RHI Humulin^® R, U-500 and
Humalog^® premixed formulations and had a comparable duration of action as RHI
Humulin^® R U-500. Based on this unique combination of rapid absorption with a
basal duration profile, BIOD-531 may provide superior meal-time glucose
control for patients using Humulin^® R, U-500. For patients using premixed
prandial/basal insulins, BIOD-531 could enable patients to minimize injection
volume while benefitting from the ultra-rapid onset of action.
The current unmet medical need for a concentrated ultra-rapid-acting insulin
formulation exists among a subset of type 2 diabetes patients who demonstrate
severe insulin resistance and require greater than 200 units of insulin daily
to meet their insulin needs. Currently Eli Lilly's Humulin^® R, U-500 is the
only concentrated RHI product on the U.S. market. Humulin^® R, U-500
concentrated insulin has a suboptimal pharmacokinetic and pharmacodynamic
profile with a more prolonged onset than U-100 insulin analog formulations.
Eli Lilly and Novo Nordisk market preparations of human insulin or
rapid-acting analog prandial insulins premixed with intermediate-acting basal
neutral protamine insulins in a variety of ratios such as 70/30, 75/25 and
50/50. Premixes provide basal and bolus therapy with fewer injections per day.
Premixes represent approximately thirty percent of the more than $8 billion
global rapid-acting prandial insulin market.
About Biodel Inc.
Biodel Inc.is a specialty biopharmaceutical company focused on the
development and commercialization of innovative treatments for diabetes that
may be safer, more effective and more convenient for
patients.Biodel'sproduct candidates are developed by applying proprietary
technologies to existing drugs in order to improve their therapeutic profiles.
More information aboutBiodelis available atwww.biodel.com.
This press release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. Such forward-looking
statements include statements about future activities related to the clinical
development plans for the company's drug candidates, including the potential
timing, design and outcomes of clinical trials; and the company's ability to
develop and commercialize product candidates. Forward-looking statements
represent our management's judgment regarding future events. All statements,
other than statements of historical facts, including statements regarding our
strategy, future operations, future clinical trial results, future financial
position, future revenues, projected costs, prospects, plans and objectives of
management are forward-looking statements. The words "anticipates,"
"believes," "could," "estimates," "expects," "intends," "may," "plans,"
"potential," "predicts," "projects," "should," "will," "would" and similar
expressions are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words. The company's
forward-looking statements are subject to a number of known and unknown risks
and uncertainties that could cause actual results, performance or achievements
to differ materially from those described or implied in the forward-looking
statements, including, but not limited to, the success of our product
candidates, particularly our proprietary formulations of injectable insulin
that are designed to be absorbed more rapidly than the "rapid-acting" mealtime
insulin analogs presently used to treat patients with type 1 and type 2
diabetes and our glucagon presentation that is intended to treat patients
experiencing severe hypoglycemia; our ability to conduct pivotal clinical
trials, other tests or analyses required by theU.S. Food and Drug
Administration, orFDA, to secure approval to commercialize a proprietary
formulation of injectable insulin or a stable glucagon presentation; the
success of our formulation development work with insulin analog-based
formulations of a proprietary injectable insulin and a stable glucagon
presentation; our ability to secure approval from theFDAfor our product
candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic
Act; the progress, timing or success of our research, development and clinical
programs, including any resulting data analyses; our ability to develop and
commercialize a proprietary formulation of injectable insulin that may be
associated with less injection site discomfort than Linjeta™ (formerly
referred to as VIAject^®), which is the subject of a complete response letter
we received from theFDA; our ability to enter into collaboration arrangements
for the commercialization of our product candidates and the success or failure
of any such collaborations into which we enter, or our ability to
commercialize our product candidates ourselves; our ability to protect our
intellectual property and operate our business without infringing upon the
intellectual property rights of others; the degree of clinical utility of our
product candidates; the ability of our major suppliers to produce our products
in our final dosage form; our commercialization, marketing and manufacturing
capabilities and strategies; our ability to accurately estimate anticipated
operating losses, future revenues, capital requirements and our needs for
additional financing; and other factors identified in our most recent report
on Form 10-Q for the quarter endedJune 30, 2013. The company disclaims any
obligation to update any forward-looking statements as a result of events
occurring after the date of this press release.
CONTACT: Seth D. Lewis
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