Clene (NASDAQ: CLNN) Announces Four-Year Grant to Support Expanded Access Protocol for CNM-Au8 From NINDS

October 25, 2023 10:44:40
  • Clene’s wholly-owned subsidiary, Clene Nanomedicine Inc., in collaboration with Columbia University and Synapticure, has been awarded a four-year grant totaling $45.1 million from the National Institute of Neurological Disorders and Stroke (“NINDS”)
  • The study will monitor safety, survival, clinical worsening, and key disease progression-related biomarkers while using CNM-Au8
  • Research conducted by Clene estimates that ALS is the most prevalent adult-onset progressive motor neuron disease, affecting approximately 30,000 people in the US and an estimated 500,000 people worldwide, with a life expectancy of diagnosed patients typically ranging from three to five years

Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company on a mission to transform the treatment of neurodegenerative diseases, recently announced that its wholly-owned subsidiary Clene Nanomedicine Inc., in collaboration with Columbia University and Synapticure, has been awarded a four-year grant totaling $45.1 million from the National Institute of Neurological Disorders and Stroke (“NINDS”). The grant will support an Expanded Access Protocol (“EAP”) for Clene’s investigational drug, CNM-Au8(R), for amyotrophic lateral sclerosis (“ALS”). The grant is supported by the National Institute of Health (“NIH”) grant U01NS136023 (https://ibn.fm/03fnZ).

An EAP, also called “Compassionate Use,” is an FDA-regulated pathway that allows people with serious and life-threatening diseases to access investigational drugs that have not yet been approved by the US Food and Drug Administration (“FDA”). In addition to the EAP, Clene plans to continue its current…

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