Clene Confident In Phase III Plans For CNM-Au8 In ALS With Six-Month Data

The company announced detailed data for the drug in the HEALEY-ALS Platform Trial, where the cohort of the Phase II/III study testing it nevertheless failed to meet the primary endpoint.

Clene announced data on CMN-Au8 from the HEALEY ALS Platform Trial • Source: Shutterstock

Although the cohort of an amyotrophic lateral sclerosis (ALS) platform trial testing Clene, Inc.’s CNM-Au8 missed its primary endpoint, the company continues to see a path forward as it regards the data as hypothesis-generating thanks to statistically significant or directional improvements on secondary endpoints.

Clene, through its Clene Nanomedicine, Inc. subsidiary, announced on 9 March detailed, six-month data from the CNM-Au8 cohort of the Phase II/III investigator-initiated HEALEY ALS Platform Trial, noting that the CNM-Au8 arm did not meet the primary endpoint of ALS functional rating scale (ALSFRS)

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