SOURCE: Biodel, Inc.

Biodel, Inc.

November 03, 2015 16:30 ET

Biodel Announces Clinical and Corporate Updates

Phase 2a Study 3-157 Initiated to Evaluate BIOD-531 Efficacy Relative to a Basal-Bolus Insulin Regimen and in Combination with GLP-1 Analog; Corporate Restructuring to Save $2 Million Annually

DANBURY, CT--(Marketwired - November 03, 2015) - Biodel Inc. (NASDAQ: BIOD) today announced the initiation of Study 3-157, a Phase 2a clinical trial to evaluate patient-friendly BIOD-531-based regimens against a state-of-the-art basal-bolus insulin regimen and in combination with a GLP-1 analog. Separately, following the completion of an operational review of the company, Biodel plans to focus on later stage clinical development programs and restructure research, quality assurance/quality control (QA/QC) and facilities activities to save approximately $2 million annually.

The Phase 2a Study 3-157 is designed to evaluate glucose control achieved with BIOD-531, Biodel's proprietary biphasic insulin formulation characterized by an ultra-rapid-acting onset and basal duration of action, compared to a state of the art "basal-bolus" regimen in patients with type 2 diabetes. The clinical trial will test the hypothesis that two or three doses of BIOD-531 alone can achieve equivalent glucose control to a commonly used intensive insulin regimen in which two different insulins are injected a total of four times per day. In addition, Study 3-157 will evaluate the clinical efficacy of co-treatment with Victoza®, a leading GLP-1 analog. Pre-clinical studies indicate that BIOD-531 can be stably co-formulated with liraglutide, the active pharmaceutical ingredient in Victoza®.

The primary endpoint for Study 3-157 is mean glucose concentration over a 24 hour period. On separate days, 14 subjects with type 2 diabetes will receive the following four treatments along with standardized meals in a randomized treatment sequence:

  • BIOD-531 with breakfast and dinner,
  • BIOD-531 with breakfast, lunch and dinner,
  • Insulin lispro (Humalog®) with breakfast, lunch and dinner plus insulin glargine (Lantus®) ("basal-bolus"), and
  • Liraglutide (Victoza®) in addition to BIOD-531 given with breakfast and dinner.

Dr. Errol De Souza, President and Chief Executive Officer of Biodel, stated: "The unique ultra-rapid-acting pharmacokinetic profile of BIOD-531, which is faster than marketed prandial insulins such as Humalog® while providing basal coverage in a single injection, may allow us to effectively compete in the large basal-bolus insulin market by reducing the injection burden and achieving glucose control at least as effective as that with separate basal and prandial insulins in patients with type 2 diabetes. Furthermore, the potential combination of BIOD-531 with a GLP-1 analog such as liraglutide could further expand the emerging basal insulin/GLP-1 combination market by providing additional superior prandial coverage. We look forward to reporting the topline data from Study 3-157 towards the end of the first calendar quarter of 2016."

In order to reduce infrastructure costs and improve efficiency of research and QA/QC-related activities, Biodel will reduce its workforce by 10 employees, or approximately 30%, which Biodel estimates will reduce annualized personnel expenses by approximately $2 million. One-time severance payments are expected to be approximately $0.3 million. The company will continue to pursue other cost controlling practices to further reduce its operating expenses.

Gary Gemignani, Chief Financial Officer of Biodel, stated: "We believe that these personnel changes will more closely align our ongoing efforts towards supporting our later-stage clinical programs, while extending our cash runway."

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'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 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.

BIOD-G

Contact Information

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