COSCIENS Biopharma Inc T.CSCI

Alternate Symbol(s): CSCI

Healthcare Biotechnology

COSCIENS Biopharma Inc., formerly Aeterna Zentaris Inc., is a specialty biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of pharmaceutical and diagnostic products, including those focused on areas of unmet medical need. Its lead product, macimorelin (Macrilen; Ghryvelin), is an oral test indicated for the diagnosis of adult growth hormone deficiency (AGHD). The Company is also engaged in the development of therapeutic assets and proprietary extraction technology, which is applied to the production of active ingredients from renewable plant resources used in cosmeceutical products (i.e., oat beta glucan and avenanthramides, which are found in skincare product brands like Aveeno and Burt’s Bees formulations) and being developed as potential nutraceuticals and/or pharmaceuticals.

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COSCIENS Biopharma Inc

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Post by prophetoffactzon Aug 27, 2024 11:30am

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Post# 36197738

Adult trial failed to meet primary endpoint but was approved

For the adult trial:

In January 2017, Aeterna Zentaris announced that the confirmatory Phase 3 clinical trial of Macrilen (macimorelin) for diagnosing adult growth hormone deficiency (AGHD) failed to meet its primary endpoint. Specifically:

The trial did not achieve equivalence to the insulin tolerance test (ITT) for diagnosing AGHD.
While the percent negative agreement met success criteria, the percent positive agreement did not reach the required threshold.
As a result, the study did not meet the pre-defined equivalence criteria.

Resolution:
Despite this setback, macimorelin was eventually approved by the FDA in 2017 and by the EMA in 2019 for diagnosing AGHD in adults. This suggests the company was able to provide additional data or analysis to support approval.

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