Clene Shares Fall Despite Multiple Sclerosis Candidate Showing Neurological Improvements

  • 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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