CLNN - Clene slips 13% as lead asset fails in ALS study
- Microcap biotech Clene Inc. ( NASDAQ: CLNN ) fell ~13% premarket Monday after the company announced that its lead candidate CNM-Au8 did not reach the primary endpoint in a placebo-controlled study involving patients with amyotrophic lateral sclerosis (ALS), a rare neurological disease.
- In the Healey ALS Platform trial, 161 participants were randomized to receive 30 mg CNM-Au8, 60 mg CNM-Au8, or a placebo over 24 weeks.
- According to topline data, the primary endpoint, based on ALS Functional Rating Scale-Revised, did not indicate a significant change at 24 weeks.
- The combined 30 mg and 60 mg CNM-Au8 doses didn’t meet the secondary endpoints at 24 weeks as per the Combined Assessment of Function and Survival (CAFS) and slow vital capacity (SVC). The complete data set from the trial are expected later this year.
- However, the company indicated a survival benefit for CNM-Au8 30 mg dose, which it expects to advance in further ALS studies.
- “To support this effort, Clene is pursuing paths, including strategic partnerships, and is in dialogue with various potential partners,” Chief Executive Rob Etherington remarked.
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Clene slips 13% as lead asset fails in ALS study