Cosciens shares plummet after growth hormone test flops in Phase III trial

Cosciens Biopharma, formerly known as Aeterna Zentaris, has published top-line results from the Phase III DETECT study of its growth hormone stimulation test macimorelin, showing that the study did not meet its primary endpoint.

The Canadian company has evaluated its macimorelin test for the diagnosis of childhood growth hormone deficiency (GHD).

The results showed that although macimorelin had the ability to stimulate growth hormone release as required to perform growth hormone stimulation assays, its efficacy was insufficient to achieve the primary outcome measure.

Following the release of the topline results, Cosciens' share price fell 32.42% compared to the previous day by the close on August 27.

Cosciens noted that a “high rate of false positives” in the comparators, namely the currently standard growth hormone stimulation tests (arginine and clonidine), may have caused the macimorelin test to miss its primary endpoint.

The Phase III DETECT trial was the second study required to seek approval of macimorelin as a diagnostic test for children, as agreed with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), according to Cosciens' pediatric investigation plan. The test is already approved in the U.S., Europe, South Korea and Israel to diagnose GHD in adults. It is marketed under the names Ghryvelin and Macrilen.

GHD is a rare disorder characterized by inadequate secretion of growth hormone from the pituitary gland. The growth hormone stimulating test is used to diagnose growth hormone deficiency in adults and children. Macimorelin is a ghrelin receptor agonist, a peptidomimetic molecule that stimulates the secretion of growth hormone from the pituitary gland.

The open-label Phase III DETECT trial (NCT04786873) enrolled participants aged 3 to 17 years who had growth hormone deficiency. The company did not provide further details on the study but said it plans to further analyze the results and discuss them with regulators in the US and EU.

Giles Gagnon, CEO of Cosciens, said: “When we receive the results of further analysis of the DETECT study, we will reassess our action plan for macimorelin. In addition, we will continue our ongoing review and prioritization process for Cosciens' pipeline.”

“Cosciens shares plunge after growth hormone testing flops in Phase III trial” was originally created and published by Clinical Trials Arena, a GlobalData brand.

The information on this website has been provided in good faith for general information purposes only. It does not constitute advice on which you should rely and we make no representation, warranty or guarantee, express or implied, as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our website.