Biodel Completes Enrollment in Phase 2 Clinical Trial of Ultra-Rapid-Acting Insulin Candidate BIOD-123 for the Treatment of Diabetes
Top-Line Data Expected in Third Quarter 2013
DANBURY, Conn., March 28, 2013 (GLOBE NEWSWIRE) -- Biodel Inc. (Nasdaq:BIOD) today announced the completion of patient enrollment in a Phase 2 clinical study of ultra-rapid-acting prandial insulin candidate BIOD-123 for the treatment of diabetes. The trial will evaluate the use of BIOD-123 versus Humalog® on measures of HbA1c, postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.
Dr. Errol De Souza, president and chief executive officer of Biodel, stated: "Completing enrollment of the BIOD-123 Phase 2 clinical trial is a significant milestone for Biodel, having nearly doubled the number of subjects in our original trial design without changing the timelines. This larger Phase 2 trial will allow us to more effectively test the benefits of a product candidate that has a more rapid absorption profile than currently marketed insulins. We remain on track to report top line data from this trial in the third calendar quarter of 2013."
The Phase 2 trial of BIOD-123 is a randomized, open label, parallel group study being conducted at approximately 30 investigative centers in the United States. In the trial, approximately 130 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 use insulin glargine, sold as Lantus®, as the basal insulin. The clinical trial will evaluate HbA1c control as the primary endpoint, and secondary endpoints include postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.
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. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles.
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 liquid glucagon formulation 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 liquid formulation of glucagon; the success of our formulation development work with insulin analog-based formulations of a proprietary injectable insulin and a liquid formulation of glucagon; 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 December 31, 2012. 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, +1-646-378-2952
Source: Biodel Inc.
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