COSCIENS Biopharma Prioritizes Natural Products After Macimorelin Trial Failure
Key Insights
COSCIENS Biopharma (search) shifts focus to natural-based products after its Phase 3 DETECT trial for macimorelin in Childhood Growth Hormone Deficiency (CGHD (search)) failed.
The company will discontinue development of macimorelin for CGHD (search), while maintaining its indication for Adult Growth Hormone Deficiency (search) (AGHD (search)).
A Phase 1 trial of Avenanthramides Tablets showed no significant side effects, with Phase 2a efficacy study expected to begin in Q1 2025.
COSCIENS Biopharma (search) Inc. (NASDAQ: CSCI) (TSX: CSCI) is strategically prioritizing its pipeline to focus on natural-based products across cosmeceuticals, nutraceuticals, and pharmaceuticals, following the failure of a Phase 3 trial for macimorelin. The company aims to leverage its core technologies in extraction and active ingredient production from renewable plant resources.
Macimorelin Development Halted for CGHD
On August 27, 2024, COSCIENS announced that the Phase 3 DETECT trial (AEZS-130-P02), evaluating macimorelin for the diagnosis of Childhood Onset Growth Hormone Deficiency (search) (CGHD (search)), did not meet its primary endpoints. Consequently, the company will cease further investment in macimorelin for CGHD, while maintaining its commercial indication for Adult Growth Hormone Deficiency (search) (AGHD (search)).
Gilles Gagnon, President & CEO of COSCIENS, stated, "We have thoroughly evaluated the potential of our assets and prioritized the areas that we believe are high-value opportunities, and we plan to move forward focusing our resources on advancing a pipeline of natural-based products leveraging our core technologies."
Avenanthramides Tablets Show Promise
The Phase 1-2a clinical trial of Avenanthramides Tablets, conducted at the Montreal Heart Institute, has completed Phase 1 with 72 subjects. The study reported no significant side effects from ascending doses ranging from 30 mg to 960 mg. The Phase 2a efficacy study is expected to commence in Q1 2025, with completion anticipated in Q3 2025. Avenanthramides are being developed as an anti-inflammatory.
Nutraceutical and Cosmeceutical Pipeline Expansion
COSCIENS is also advancing its nutraceutical and cosmeceutical offerings:
- Yeast Beta Glucan (YBG) Powder: A YBG product has been successfully manufactured and is being finalized in capsule form for commercialization as an immune booster in Q2 2025.
- Oat Beta Glucan (OBG) Chewable Bar: A standardized formulation for a healthy confection containing a high concentration of OBG has been developed. This product boasts approved health claims in 10 developed countries, including reduction of LDL cholesterol and support for cardiovascular health. The commercial launch is anticipated in Q1 2025.
- Enriched Oat Flour: The company has successfully produced and sold small batches of enriched oat flour with a high concentration of avenanthramides for inclusion in cream formulations.
- JuventeDC Product Line: A new website, juventedc.com, was launched on December 19, 2024.
Management Restructuring
As part of the streamlining of operations and cost reduction efforts, some management roles have been terminated, including that of Dr. Nicola Ammer, Chief Medical Officer, with her departure scheduled for March 31, 2025.
COSCIENS plans to release a new corporate presentation outlining key development areas and upcoming milestones in January 2025.