The Clene Inc. (NASDAQ: CLNN) stock price soared 77% after releasing MRI data from multiple sclerosis (MS) patients in its VISIONARY-MS phase 2 clinical trial. The MRI data reinforced the clinical neurological improvements previously reported by the company.
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Investors cheered the MRI results since they showed improved brain neuronal structural integrity independent of an immunomodulatory effect. The results supported the statistically significant clinical improvements in low contrast vision and global neurological function in stable relapsing MS patients reported earlier in the mITT population.
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The trial tested the efficacy and safety of CNM-Au8® (15 mg or 30 mg daily) versus placebo over 48 weeks in stable relapsing-remitting MS participants with chronic optic neuropathy. Nearly all participants (92%) were treated with highly effective disease-modifying therapies (DMT) as the background standard of care.
The MRI findings provide evidence of brain neuronal structural integrity assessed by diffusion tensor imaging (DTI), demonstrating statistically significant results for axonal integrity and white matter integrity, independent of an immunomodulatory effect. Results include all participants with advanced MRI data collection (n=68).
Investors were happy that the DTI results independently demonstrated improvements across fractional anisotropy, radial diffusivity, and mean diffusivity, each favouring CNM-Au8 treated participants across all nine prespecified brain regions and brain white matter tracts for each metric.
Similarly, the MRI measures of improved myelin integrity, including magnetisation transfer ratio and myelin water fraction, consistently favoured CNM-Au8 treated participants across all brain regions and white matter tracts investigated. Additional lesion MRI analyses are underway.
Robert Glanzman, MD, FAAN, Clene’s Chief Medical Officer, said:
“Importantly, these data further reinforce our hypothesis that improving brain energetic metabolism results in improved neurological structure and function when CNM-Au8 is administered as an adjunct to standard immunomodulatory disease-modifying MS therapies. Clene plans to initiate a fully powered Phase 3 study to demonstrate improved global neurological function in patients with progression independent of relapse activity, the most urgent unmet need in MS today, in collaboration with a development partner. We look forward to presenting these MRI data at the upcoming Americas Committee for Treatment and Research in Multiple Sclerosis forum on February 22-25, 2023.”
*This is not investment advice.
The Clene (CLNN) stock price soared 77.04% to trade at $2.39, from Friday’s closing price of $1.35.
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