Clene presents extended survival data on CNM-Au8 from HEALEY ALS trial

Clene and its wholly owned subsidiary Clene Nanomedicine presented new long-term CNM-Au8 treatment results for survival and neurofilament light levels from the HEALEY ALS Platform Trial open label extension at the European Network for the Cure of ALS meeting in Stockholm, Sweden. The data presentation, titled “Long-Term CNM-Au8 Treatment Reduces Neurofilament Light Levels and Improves Survival: Results from the HEALEY ALS Platform Trial,” highlights up to 42 months of survival follow-up and 76 weeks of long-term NfL biomarker results, including a responder subset from the HEALEY ALS Platform Trial in participants with ALS. All participants treated with CNM-Au8 30 mg, including ex-placebo participants who transitioned to CNM-Au8 in the OLE, with complete baseline co-variates were included in the survival analysis. Improved Survival Compared to Matched PRO-ACT Controls: Survival analyses of participants originally randomized to CNM-Au8 30 mg treatment and ex-placebo to CNM-Au8 compared to matched PRO-ACT controls up to 3.5 years post-baseline. Approximately 60% decreased risk of death in CNM-Au8 30 mg treated patients compared to matched PRO-ACT controls up to 3.5 years of follow-up; covariate-adjusted hazard ratio: 0.431, p-value = 0.0002. Reduced Neurofilament Light Biomarker Levels in NfL Responders: NfL Responder Subset: The NfL responder analysis was completed to identify NfL decreases in participants who showed consistent NfL declines. Responders were defined as participants who had all post-baseline measures with an NfL decrease or repeated declines of at least 10 pg/mL following the start of CNM-Au8 treatment: Responders demonstrated an average NfL reduction of 28%, which is suggestive of decreased axonal loss on an ongoing basis; GMR at Week 76 change vs. baseline: 0.72, pless than0.0001; The NfL results are based on earlier announced analyses of plasma NfL collected from participants in the HEALEY OLE who were treated with CNM-Au8 30 mg through week 76 compared to participants treated with placebo for 24 weeks prior to crossing over to active treatment for up to 52 weeks. Long-term treatment with CNM-Au8 30 mg resulted in continued significant decline of plasma NfL levels. The geometric mean ratio vs. placebo at week 76 was 0.841, 95% CI: 0.73 – 0.98, p=0.023. CNM-Au8 was safe and well-tolerated during the OLE.