Clene Could be Big Part of “Momentous Year” for ALS Research

Amyotrophic lateral sclerosis (ALS) is a devastating disease. For years, pharmaceutical companies have been striving to develop therapies to help patients who face certain death but have mostly come up short. Now though, there is a renaissance in ALS drug development with multiple shots being taken on goal, including Clene, Inc.’s add-on treatment, CNM-Au8, which is generating positive clinical data.

CNM-Au8 is an investigational gold bioenergetic nanocatalyst that can be used as an add-on to care in multiple neurodegenerative diseases, including ALS, Parkinson’s and multiple sclerosis. The investigational asset is designed to catalyze biocelluar reactions and, so far in clinical studies, is “golden.”

This month, Clene presented updated clinical data from its Phase II RESCUE-ALS study that indicate the addition of its nanocrystal asset boosts chances of survival. Interim data show an approximately 70% decreased risk of death for participants who entered the RESCUE-ALS long-term open-label extension.

The strength of the updated data from the RESCUE-ALS study could be a good predictor of what Clene hopes to see later this summer from the Phase III HEALEY study, which is assessing multiple treatments at one time including CNM-Au8. Data from the HEALEY study is expected in the third quarter. Once the data is unblinded, it will be sorted by teams from Harvard University and Massachusetts General Hospital.

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