The study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of ALTU-238 in normal healthy volunteers. Altus now plans to initiate a multi-center phase II clinical trial to study the safety and biological activity of repeated doses of ALTU-238 in adults with growth hormone deficiency.
Sheldon Berkle, president and CEO of Altus Pharmaceuticals said, “We believe that ALTU-238 will provide patients with a long-acting treatment option that has comparable efficacy and safety to existing therapies, but with fewer injections, less discomfort, and improved compliance.”
ALTU-238 is a novel, long-acting subcutaneous formulation of recombinant human growth hormone. Such hormones are approved for treating multiple growth disorders in children, adolescents and adults. Global sales of recombinant human growth hormone were approximately $2.2 billion in 2004.