Altus Pharmaceuticals has announced results from a multicenter Phase II clinical trial in growth-hormone-deficient adults for ALTU-238, a long-acting crystalline formulation of recombinant human growth hormone (hGH, somatropin). ALTU-238 is being developed as a subcutaneously administered, once-per-week formulation of human growth hormone that employs Altus' proprietary protein crystallization and formulation technology.
The Phase II clinical trial was conducted using two dose levels of ALTU-238 in adults with growth hormone deficiency. The primary objectives of the trial were to determine the safety and tolerability of ALTU-238, as well as to evaluate its pharmacokinetic and pharmacodynamic profile. ALTU-238 was administered once-per-week, using a fine 30-gauge needle, over a three-week period. The results of the trial confirmed results of earlier Phase I studies of ALTU-238 in which the pharmacokinetic and pharmacodynamic profile observed was supportive of a once-per-week injection of ALTU-238.