The products achieved the target pharmacokinetic, pharmacodynamic and toleration profiles in a Phase I trial and BIOD-123 is expected to advance to Phase II in the third calendar quarter of 2012.
The company has announced the continuing development of ultra-rapid-acting insulin analog-based formulations with selection of candidates and initiation of a Phase I trial projected in the second half of calendar year 2012.
Biodel anticipates NDA submission of Liquid glucagon formulation for use as a rescue treatment for patients experiencing severe hypoglycemia in the fourth calendar quarter of 2013 or first calendar quarter of 2014.
Biodel chief medical officer Alan Krasner said the company’s previous Linjeta formulation demonstrated a desirable ultra-rapid absorption profile, but had challenges with respect to local injection site toleration.
"The goal of our subsequent formulation development has been to maintain the ultra-rapid absorption profile of Linjeta™, while improving injection site toleration," Krasner added.
"These recent data suggest that our latest formulations have achieved this goal, and we feel that further clinical development is warranted."