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Clene Reports First Quarter 2023 Financial Results and Recent Operating Highlights
ALS biomarker and long-term clinical data expected mid-yearNeurology expert Ben Greenberg, M.D., M.H.S., joined as Head of Medical SALT LAKE CITY, May 12,
About this update from Clene Inc.
[{"type":"text","content":"ALS biomarker and long-term clinical data expected mid-yearNeurology expert Ben Greenberg, M.D., M.H.S., joined as Head of Medical SALT LAKE CITY, May 12, 2023 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on revolutionizing the treatment of neurodegenerative diseases, today announced its first quarter 2023 financial results and provided recent operating highlights for the clinical programs in amyotrophic lateral sclerosis (“ALS”) and multiple sclerosis (“MS”). “Clene is approaching several important data milestones in ALS,” said Rob Etherington, President and CEO of Clene. “These include key biomarker data that may support accelerated FDA approval as well as additional long-term survival data from both the HEALEY ALS Platform trial and our RESCUE ALS open-label extension trial. These data will inform our regulatory strategy as we plan ahead for our end-of-Phase 2 meeting with the FDA in the third quarter. In parallel, we are planning to advance regulatory discussions about MS anticipated in the fourth quarter and continue our pursuit of opportunities to establish a partnership for this program.” First Quarter 2023 and Recent Operating Highlights CNM-Au8®, a gold nanocrystal suspension, for the treatment of ALS A poster entitled “Evidence for Survival Benefit in ALS with CNM-Au8 Treatment Across Three Study Populations” was presented on April 25th by Dr. James Berry at the American Academy of Neurology conference and included the following highlights: Survival in Early-to-Mid Stage ALS: CNM-Au8 30 mg demonstrated a statistically significant survival benefit of 60% and decreased risk of death through 120 weeks versus original placebo randomization in during follow-up of participants in the RESCUE-ALS trial .Survival in Mid-to-late stage ALS: CNM-Au8 30mg was associated with risk adjusted survival benefit of >90% and decreased risk of death through 24 weeks versus placebo in participants with mid-to-late stage ALS in the HEALEY ALS Platform trial.Survival from real world experience in ALS: CNM-Au8 30mg demonstrated observed median survival of more than three years in analyses of two compassionate use expanded access protocols. CNM-Au8 for the treatment of MS A platform presentation enti...