SOURCE: Biodel, Inc.

May 21, 2015 07:00 ET

Biodel Announces Phase 2b Clinical Trial Initiation of BIOD-531, the Company's Concentrated, Ultra-Rapid-Acting, Prandial/Basal Combination Insulin Candidate

DANBURY, CT--(Marketwired - May 21, 2015) - Biodel Inc. (NASDAQ: BIOD) today announced the initiation of a Phase 2b clinical trial of BIOD-531, the Company's concentrated, proprietary, recombinant human insulin (RHI) based ultra-rapid-acting prandial/basal combination insulin candidate.

The Phase 2b trial, Study 3-250, is a randomized, open-label, parallel group study in patients with insulin-treated type 2 diabetes. Approximately 130 patients are targeted for enrollment at 25 U.S. investigative centers. Patients will be randomized to receive either BIOD-531 or Humalog® Mix 75/25 dosed twice daily. Patients will be treated for 18 weeks, the first six weeks of which will focus on active dose titration. The primary analysis will evaluate change from baseline in HbA1c, while secondary endpoints will compare postprandial glucose excursions, hypoglycemic event rates and weight changes. Top line results are expected in mid-2016.

Dr. Errol De Souza, Biodel's president and chief executive officer, stated: "BIOD-531 has shown in three clinical studies to be associated with a best-in-class, ultra-rapid insulin profile and a basal duration of action appropriate for twice daily dosing. We believe this pharmacokinetic profile of BIOD-531 to be superior to that of existing products that are marketed as combinations of prandial and basal insulin, namely Humulin® R U-500 and pre-mixed insulins such as Humalog® Mix 75/25. As a result, postprandial glucose has been shown to be better controlled with BIOD-531 after standardized meals. Pre-mixed insulins represent a multi-billion dollar product category that is often used in clinical practice for patients for whom intensive insulin regimens are not practical or appropriate. Because of slow absorption of the prandial component, the use of pre-mixed insulins sacrifice meal-time glucose control. We believe BIOD-531 is well suited to provide real meal time control in this insulin product category."

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. 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 Biodel's product candidates, potential timing, design and outcomes of clinical trials and Biodel's ability to develop and commercialize its product candidates. Forward-looking statements represent Biodel's management's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding Biodel's 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. Biodel'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 progress, timing or success of Biodel's research and development and clinical programs for Biodel's product candidates; Biodel's ability to conduct the development work necessary to finalize the formulation and design of Biodel's auto-reconstitution glucagon rescue product candidate, as well as the preclinical studies, clinical trials and manufacturing activities necessary to support the filing of a new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, for that product candidate; Biodel's ability to engage a strategic partner in the further development of Biodel's prandial ultra-rapid-acting insulin formulations, including BIOD-531, which uses regular human insulin, or RHI, as the active pharmaceutical ingredient, and Biodel's insulin analog-based formulations; the success of Biodel's formulation development work to improve the stability of Biodel's newer ultra-rapid-acting insulin analog-based formulations while maintaining the pharmacokinetic and injection site toleration characteristics associated with earlier formulations; the results of Biodel's real-time stability programs for Biodel's RHI-, insulin analog- and glucagon-based product candidates, including the reproducibility of earlier, smaller scale, stability studies and Biodel's ability to accurately project long term stability on the basis of accelerated testing; Biodel's ability to accurately anticipate technical challenges that the company may face in the development of Biodel's ultra-rapid-acting RHI- and insulin analog-based product candidates or Biodel's glucagon rescue product candidates; Biodel's ability to secure approval by the FDA for Biodel's product candidates under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act; Biodel's ability to enter into collaboration arrangements for the commercialization of Biodel's product candidates and the success or failure of any such collaborations into which the company enters, or Biodel's ability to commercialize its product candidates on its own; Biodel's ability to enforce Biodel's patents for Biodel's product candidates and Biodel's ability to secure additional patents for Biodel's product candidates; and other factors identified in our most recent annual report on Form 10-K for the fiscal year ended September 30, 2014 and other subsequent filings with the Securities and Exchange Commission. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.

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Contact Information

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