- Clene Inc CLNN has announced topline results from the Phase 2 VISIONARY-MS trial of CNM-Au, an investigational gold nanocrystal suspension, in stable relapsing-remitting multiple sclerosis.
- As announced in February, the trial was stopped prematurely due to COVID-19 pandemic operational challenges, limiting enrollment to 73 out of the 150 planned participants.
- CNM-Au8 met primary and secondary endpoints of Low Contrast Letter Acuity and modified Multiple Sclerosis Functional Composite compared to placebo over 48 weeks in the mITT population.
- Also Read: Clene's CNM-Au8 Shows Decreased Mortality Amyotrophic Lateral Sclerosis Patients.
- Consistent improvements favoring CNM-Au8 were seen across paraclinical biomarkers.
- CNM-Au8 treatment was well-tolerated, and there were no significant safety findings reported.
- Rob Etherington, CEO & president, added, "we also await additional evidence of clinical efficacy from the HEALEY ALS Platform Trial, which is expected to report topline data later this quarter."
- Clene ended Q2 with cash, cash equivalents, and marketable investment securities of $26.3 million and entered into a $3.0 million loan facility to support the development of a commercial manufacturing facility.
- Price Action: CLNN shares are down 8.41% at $3.16 during the premarket session on the last check Monday.
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