Positive Phase I Data from Biodel
Biodel Inc. (BIOD) announced preliminary results from a phase I study (3-150) of BIOD-531, the company’s lead candidate for an ultra-rapid-acting insulin formulation. This study, conducted on non-diabetic obese volunteers, confirmed the results of earlier pre-clinical findings in diabetic swine. The results showed that BIOD-531 demonstrates rapid absorption and onset of action, as well as an extended duration of action which should be suitable for basal insulin requirements.
The study evaluated the pharmacokinetic and pharmacodynamic parameters and injection site toleration of single doses of BIOD-531 (both 1.0 units/kg and 0.5 units/kg) in comparison with Eli Lilly’s (LLY) Humulin R U-500 (1.0 units/kg dose) and Humalog Mix 75/25 (0.5 units/kg dose).
Biodel intends to initiate a phase II meal study of BIOD-531 in diabetic patients to assess its benefits on post prandial control of glucose. The company will also work with the U.S. Food and Drug Administration (:FDA) to start a late stage trial of BIOD-531 based on results from earlier studies.
Currently, the diabetes market is highly crowded with players like Eli Lilly and Novo Nordisk (NVO) among others. Recent entrants in the market include products like Victoza and Bydureon among others. We expect investor focus to remain on further pipeline updates from Biodel. Besides BIOD-123, the company has other recombinant human insulin-based formulations in earlier stages of development.
Biodel carries a Zacks Rank #2 (Buy). A better-ranked stock in the biotech sector is Auxilium Pharmaceuticals Inc. (AUXL) with a Zacks Rank #1 (Strong Buy).
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