Aeterna Zentaris' AEZS-130 demonstrates potential as oral diagnostic test for AGHD

Oct 6 2010

Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ), today announced that an interim review of a Phase 3 trial of AEZS-130 (macimorelin, Solorel^TM), demonstrates the compound may provide a simple, well-tolerated and safe oral diagnostic test for Adult Growth Hormone Deficiency (AGHD). The data was presented earlier today by Beverly M.K. Biller, M.D. of the Harvard Medical School/Massachusetts General Hospital in Boston, at the 5th International Congress of the Growth Hormone Research Society (GRS) and the Insulin-like Growth Factors (IGF) Society in New York City. AEZS-130 (macimorelin, Solorel^TM) has been granted Orphan Drug Designation by the Food and Drug Administration (FDA) as a diagnostic test for AGHD.

The study was initiated to compare the performance of AEZS-130 (macimorelin, Solorel^TM) against the then-available diagnostic growth hormone releasing hormone (GHRH) + Arginine (ARG) standard test. GHRH was subsequently removed from the market in 2008. At the time of removal, the trial consisted of 42 patients with AGHD and ten control subjects. The performance of both diagnostic tools in these patients was examined by investigators who were encouraged by the preliminary sensitivity and specificity estimates for AEZS-130 (macimorelin, Solorel^TM).

"Following this encouraging data, we look forward to completing this Phase 3 trial by the end of this year and filing a New Drug Application in the first half of 2011", stated Juergen Engel, Ph.D., president and CEO at Aeterna Zentaris. "In line with our innovative approach, AEZS-130 (macimorelin, Solorel^TM) could become the first approved oral test for the diagnosis of AGHD, providing patients with an accurate and more convenient alternative to the current intravenous tests."

In the study, investigators found that at peak growth hormone responses, oral AEZS-130 (macimorelin, Solorel^TM) demonstrated 95% sensitivity and 90% specificity in identifying patients who should receive therapy for AGHD, as compared to the then-available standard intravenous test of GH releasing hormone (GHRH) followed by arginine (ARG) which had an 86% sensitivity and 90% specificity.

Source: AETERNA ZENTARIS INC.