Cosciens Biopharma, previously known as Aeterna Zentaris, has released topline results from the Phase III DETECT trial of its macimorelin growth hormone stimulation test, showing that the study failed to meet the primary endpoint.
The Canadian company evaluated its macimorelin test to diagnose childhood-onset growth hormone deficiency (GHD).
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The results showed that while macimorelin demonstrated a capacity to stimulate growth hormone release as required for performing growth hormone stimulation tests, it failed to show enough efficacy to meet the primary endpoint.
After the topline results were released, Cosciens stock dropped by 32.42% at market close on 27 August, compared to the previous day.
Cosciens noted that “a high false positive rate” among the comparators, namely the current standard growth hormone stimulation tests (arginine and clonidine), could have led to the macimorelin test missing its primary endpoint.
The Phase III DETECT trial was the second study needed to file for regulatory approval of macimorelin as a diagnostic test in children as agreed upon with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), according to Cosciens’ paediatric investigation plan. The test is already approved for diagnosing adult GHD in the US, Europe, South Korea, and Israel. It is marketed as Ghryvelin and Macrilen.
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By GlobalDataGHD is a rare disorder characterised by the inadequate secretion of growth hormone from the anterior 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 between ages 3-17 years who had GHD. The company was light on trial details but noted that it plans to analyse the results further and discuss the same with regulatory agencies in the US and EU.
Cosciens’ CEO Giles Gagnon said: “As we get the results of further analysis of the DETECT trial, we will be considering our action plan for macimorelin. In addition, we will continue our ongoing review and prioritisation process for Cosciens’ pipeline.”
