Positive mid-phase data for Altus’ growth treatment

ALTU-238 is being developed as a subcutaneously administered, once-per-week formulation of human growth hormone. The company hopes that the once-per-week dosing of the product will offer a benefit over currently available treatments for the disease which require a daily dosing.

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 this trial confirmed results of earlier phase I studies of the drug in which the pharmacokinetic and pharmacodynamic profile observed was supportive of a once-per-week injection of ALTU-238.

The study identified doses of ALTU-238 that maintained IGF-1 levels within the normal range for age and gender over the course of the study. Once-per-week dosing of ALTU-238 appeared to result in a consistent, linear dose response of hGH and IGF-1 levels in the blood. Altus anticipates that these positive results will support dose selection for ALTU-238 in upcoming phase III trials in adults and pediatric patients which we anticipate will start later this year.

ALTU-238 was shown to be well-tolerated by patients enrolled in the study with generally mild injection site reactions being the most commonly reported event. No serious adverse events or antibody formations were reported.

“ALTU-238 could represent a significant milestone in the treatment of growth hormone disorders, offering greater patient convenience, comfort and improved compliance,” said Sheldon Berkle, president and CEO of Altus.