NetworkNewsBreaks – Clene Inc. (NASDAQ: CLNN) Re
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Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc. are reporting on long-term follow-up data for participants in the HEALEY ALS Platform Trial; patients in the study were treated with CNM-Au8(R) 30mg for up to 133 weeks. According to the announcement, data from 59 patients shows prolonged life with 49% decreased risk of death for participants compared to PRO-ACT matched placebo over long-term follow-up; data also showed prolonged life with 59% decreased risk of death for participants in an integrated meta-analysis across HEALEY ALS Platform Trial and RESCUE-ALS Trial with CNM-Au8 30mg compared to PRO-ACT matched placebo over long-term follow-up. In addition, the announcement noted that the study included more than 500 patient years of CNM-Au 8treatment exposure without any identified safety signals. The HEALEY ALS Platform Trial is a perpetual multicenter, randomized, double-blind, placebo-controlled clinical trial program designed to study and analyze the efficacy and safety of multiple investigational products with people living with ALS. Trial officials noted that improved survival status is a key measure of drug effect. “To show such profound survival improvement using the HEALEY ALS Platform Trial data set alone and a pooled HEALEY and RESCUE data set is remarkable and helps confirm the survival benefit seen in the prespecified secondary endpoint,” said Clene head of medical Benjamin Greenberg, M.D. in the press release. “Clene is extremely gratified to see this consistent long-term survival data from the HEALEY ALS Platform Trial OLE, with a continued clean safety profile, adding to the totality of the survival evidence.”
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