Biodel Inc. (NASDAQ:BIOD) to Focus on Later Stage Clinical Development Programs, Initiates Study 3-157


Biodel Inc. (NASDAQ:BIOD) is planning to concentrate on restructuring research and later stage programs related to clinical development. Earlier in November, the company announced the initiation of the Study 3-157, a clinical trial for the evaluation of the patient-friendly BIOD-531 based regimens. The Phase 2a clinical trials are to be evaluated in combination with the GLP-1 analog.

The next step for the company will be to keep its focus more on to save around $2 million annually by restructuring the facilities activities, quality control and quality assurance and research programs.

Study to Evaluate Glucose Control

The Phase 2a Study 3-157 evaluates glucose control obtained through BIOD-531, a proprietary biphasic insulin formulation from Biodel. The formulation exhibits ultra-rapid-acting onset as well as the basal duration of action against the state-of-the-art ‘basal bolus’ regimen commonly found in type 2 diabetes patients.

The study will also focus on evaluating the clinical efficacy of a leading GLP-1 analog, Victoza™ when used as co-treatment. The pre-clinical studies have already indicated that the BIOD-531 can adequately co-formulate the active pharmaceutical ingredient in Victoza™, liraglutide.

The primary treatment will include the participation of 14 patients with type 2 diabetes, subjected to four treatments on separate days. The patients will be provided with standardized meals, albeit in a random sequence.

BIOD-531 Faster Than Humalog™

According to the Chief Executive Officer and President of Biodel, Dr. Errol De Souza, BIOD-531 is faster than the other currently marketed prandial insulins including Humalog™. The CEO stated that BIOD-531 is integrated with a unique ultra-rapid-acting pharmacokinetic profile due to which the formulation can provide basal coverage with just one injection.

The President is hopeful that the introduction of BIOD-531 in the market can prove helpful in reducing the burden of injecting and achieving glucose control much more effectively with type 2 diabetes patients.

Reduce Infrastructure Cost by Cutting Down Workforce

Biodel Inc. (NASDAQ:BIOD) a leading biopharmaceutical company is planning to reduce its infrastructure cost by cutting down 10 employees. The Chief Financial Officer, Gary Gemignani, Biodel has stated that the company aims to lower the expenses by 30% so that annually around $2 million can be saved.

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