AEterna Reports Positive Results for its Oral Growth Hormone Secretagogue

AEterna Zentaris has released positive results in a Phase I study of its oral growth hormone secretagogue (GHS), EP-1572.

Conducted by Ardana, AEterna Zentaris' development and marketing partner for EP-1572, the study provides clear evidence that this compound is able to induce a significant rise in growth hormone levels. Potential applications include treatment for growth retardation in children and cachexia associated with chronic disease such as AIDS and cancer.

EP-1572, the only orally administered specific GHS in development, presents a major competitive advantage in terms of ease and convenience of delivery over current treatments that are only available through injections.

The open, randomized, placebo-controlled dose-escalation Phase I study involved a total of 36 healthy male volunteers, divided into three groups of 12 volunteers. Nine subjects in each group received a single oral dose of EP-1572 -- 0.005 mg/kg in the first group, 0.05 mg/kg in the second group and 0.5 mg/kg in the third group -- with the other three subjects in each group receiving a placebo. All subjects had been initially checked for their ability to release growth hormone by the intravenous administration of another hormone, growth hormone releasing hormone (GHRH).

The data demonstrated that between one and two hours after drug administration there was a statistically significant increase in the levels of growth hormone in the blood without any effect on other hormones. In all cases, EP-1572 was well-tolerated, and no adverse events were reported.