Altus is developing ALTU-238 as a subcutaneously administered, long-acting formulation of rhGH that employs the company’s proprietary protein crystallization and formulation technology.
Sandoz supplied rhGH for Altus’s completed Phase I clinical trial in healthy adults and the Phase II clinical trial in adults with growth hormone deficiency.
Georges Gemayel, president and CEO of Altus, said: “We are targeting early 2009 to start an ALTU-238 Phase II pediatric trial. With this goal in mind, we expect to initiate a Phase Ic study in the third quarter of 2008.”
The ALTU-238 Phase Ic trial is planned to be initiated by the end of the third quarter of 2008 and is expected to include 36 subjects. The safety and pharmacokinetic profile of ALTU-238 will be evaluated over one week. The trial is designed to confirm that the ALTU-238 material produced at Althea Technologies at approximately 75% of commercial scale performs similarly to the material used in the previous Phase I and Phase II trials.
This will be followed by the Phase II pediatric trial, which will assess the change in six-month annualized height velocity in pediatric growth hormone-deficient children, and will be used to finalize the Phase III study design.