Biodel Announces Completion of Dosing in Phase 2 Clinical Trial of BIOD-123 in Patients With Type 1 Diabetes
July 11 2013 - 6:00AM
Biodel Inc. (Nasdaq:BIOD) today announced that all scheduled
follow-up visits have been completed for patients enrolled in the
Phase 2 clinical trial of BIOD-123, an investigational
ultra-rapid-acting injectable mealtime insulin therapy.
Dr. Errol De Souza, president and chief executive officer of
Biodel, stated: "Completing the BIOD-123 Phase 2 clinical trial is
another significant milestone in the development of novel
ultra-rapid-acting mealtime insulins to aid patients and healthcare
professionals in the treatment of diabetes. We look forward to
sharing the top-line results by the end of this quarter."
Study Design
The Phase 2 clinical trial of BIOD-123 is a randomized, open
label, parallel group study conducted at 33 investigative centers
in the United States. In the trial, 132 patients with type 1
diabetes were randomized to receive either BIOD-123 or Humalog® to
use as their mealtime insulin during an 18 week treatment period.
Both arms of the study used insulin glargine, sold as Lantus®, as
the basal insulin. The clinical trial is designed to evaluate HbA1c
control as the primary endpoint, and secondary endpoints include
postprandial glucose excursions, glycemic variability, hypoglycemic
event rates and weight changes.
About BIOD-123
BIOD-123 is a proprietary formulation of injectable recombinant
human insulin with EDTA, citrate and magnesium sulfate. It is
designed to be more rapid-acting than mealtime insulin analogs
currently used to treat patients with type 1 and type 2 diabetes.
In earlier-stage clinical trials, BIOD-123 has been shown to be
more rapidly absorbed following subcutaneous administration and
have comparable injection site tolerability relative to the
rapid-acting insulin analog marketed as Humalog®. Administered at
the start of a meal, the time to peak insulin levels achieved by
BIOD-123 more closely mimics the first-phase mealtime insulin
release observed in healthy individuals. Since its inception in
2006, Biodel's ultra-rapid-acting insulin program has involved 20
clinical studies and more than 1,000 patients with diabetes.
About Diabetes
Diabetes is a group of diseases characterized by high blood
glucose levels that result from defects in the body's ability to
produce and/or use insulin. Humans need a minimum level of glucose
in their blood at all times to function and stay alive. Insulin is
a peptide hormone naturally secreted by the pancreas to regulate
the body's management of glucose. When a healthy individual begins
a meal, the pancreas' rapid release of insulin, known as
first-phase insulin release, is critical to the body's overall
control of glucose. Many patients with diabetes lack first-phase
insulin release and must treat themselves with daily meal-time
insulin injections to avoid the negative effects of
hyperglycemia.
About Biodel
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's product candidates are developed by applying
proprietary technologies to existing drugs in order to
improve their therapeutic profiles. More information about Biodel
is available at www.biodel.com.
Safe-Harbor Statement
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 successfully complete a Phase 2
clinical trial of a proprietary insulin formulation in a timely
manner, and the outcome of that trial; our ability to conduct
pivotal clinical trials, other tests or analyses required by the
U.S. Food and Drug Administration, or FDA, 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 the FDA for 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 the FDA; 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 ended March 31, 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.
BIOD-G
CONTACT: Seth D. Lewis, +1-646-378-2952
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