Biodel Inc. Announces Positive Preliminary Results from Phase 1 Clinical Trial for Glucagon Emergency Management Device

Strategic Insights -

Biodel Inc. recently announced positive preliminary results from Study 6-101, a Phase 1 clinical trial comparing the company's lyophilized glucagon formulation BIOD-961 to Eli Lilly's Glucagon Emergency Rescue Kit and Novo Nordisk's GlucaGen HypoKit, both marketed for the treatment of severe hypoglycemia. The study aimed to evaluate the pharmacokinetic and pharmacodynamic profiles of BIOD-961 in comparison to the marketed glucagon formulations.

Key Takeaways:

  • The study was a randomized, single-center, double-blind, six-period crossover study in 15 healthy volunteers who received each glucagon administered subcutaneously (SC) and intramuscularly (IM) in a randomized treatment sequence.
  • The primary objectives of the study were to compare the pharmacokinetic (PK) profiles, the pharmacodynamic (PD) responses, and the PK/PD relationships of IM and SC dosing of the three test glucagons.
  • The results of the study showed that BIOD-961 demonstrated comparable pharmacokinetic and pharmacodynamic profiles to marketed glucagon formulations, exceeding expectations.
  • Human factors study planned for the first half of 2015 to compare the usability of the GEM device to existing manually reconstituted commercial glucagon kits.
  • The GEM device has been designed to be user-friendly and eliminate the possibility of dosing only with diluent, reducing the risk of accidental needle stick injuries.
  • Biodel plans to request an end-of-Phase 2 meeting with the FDA in the second calendar quarter of 2015 and submit the NDA in mid-2016.

Statistics:

  • The annual U.S. glucagon market for the treatment of severe hypoglycemia is approximately $160 million.
  • The GEM device is expected to be available in separate presentations for pediatric (0.5 mg) and adult (1.0 mg) dosages of glucagon.
  • The study was conducted in 15 healthy volunteers, with 10 completing all dosings.

Sources:

  • Biodel Inc. (via Marketwired)
  • Comtex SmarTrend Alert (via Marketwired)