Clene Inc. plans to sit down in the third quarter of this year with the U.S. FDA for talks about approval for gold nanocrystal suspension CNM-Au8, bolstered by favorable biomarker findings in amyotrophic lateral sclerosis (ALS) from the phase II/III Healey ALS platform trial – along with a sizeable time-to-event and survival data package that should drive the conversation.
Updated MRI results from Clene Inc.’s phase II Visionary-MS trial testing gold nanocrystal therapy CNM-Au8 bolsters the company’s premise that targeting energy metabolism could protect neuronal function in patients with multiple sclerosis and lays the groundwork for a phase III trial as soon as a strategic partner is found.
Though Wall Street may not have caught on to the value of Clene Inc.’s phase II results with gold nanocrystal suspension CNM-Au8 in amyotrophic lateral sclerosis (ALS), CEO Rob Etherington said his firm is “truly excited” about the data, which bode well for the next stage of development, already underway.
What’s new inevitably includes an element of the old. Clene Nanomedicine Inc., which just completed enrollment and dosed the first patient in its phase II trial in amyotrophic lateral sclerosis (ALS), literally contains an element of the old in its lead nanocatalytic therapy: gold.
