This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Biodel Announces Phase 2 Clinical Trial Initiation Of Ultra-Rapid-Acting Insulin Candidate BIOD-123





DANBURY, Conn., Sept. 13, 2012 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) today announced the initiation of a Phase 2 clinical trial of its proprietary recombinant insulin (RHI)-based ultra-rapid-acting mealtime insulin candidate, BIOD-123.  

"We are pleased to achieve another milestone in the development of BIOD-123. We continue to meet our timelines and project that we will be able to communicate top-line Phase 2 safety and efficacy data in the third calendar quarter of 2013," stated Dr. Errol De Souza, president and chief executive officer of Biodel.

Dr. Alan Krasner, Biodel's Chief Medical Officer, stated:  "This Phase 2 study is designed to assess the clinical impact of the ultra-rapid absorption profile of BIOD-123 relative to currently marketed mealtime insulin analogs.  There is room for improvement in the area of mealtime insulin therapy and we are hopeful that this new candidate will help usher in a new insulin class designed to achieve better meal time outcomes for patients with diabetes."

In April 2012, Biodel announced positive top-line results from a Phase 1 clinical trial of BIOD-123, which demonstrated that the formulation had a more rapid absorption than insulin lispro, sold as Humalog ®, with comparable injection site tolerability.

The Phase 2 study is a randomized, open label parallel group study enrolling 130 patients with Type 1 diabetes at approximately 30 U.S. investigative centers. The patients are randomized to receive either BIOD-123 or insulin lispro as their mealtime insulin over an 18 week treatment duration. Both arms of the study use insulin glargine, sold as Lantus ®, as the basal insulin. The primary endpoint compares changes in HbA1c, while secondary endpoints compare postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes.

About Biodel Inc.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,034.93 +208.63 1.17%
S&P 500 2,100.40 +19.22 0.92%
NASDAQ 4,994.6020 +62.7870 1.27%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs