Highlights:
Clene has released updated trial data for their Visionary Multiple Sclerosis Phase II studies, in which its primary pipeline candidate, CNM-Au8, is being studied as a therapy for relapsing forms of multiple sclerosis with persistent optic neuropathy. As the first drinkable treatment based on a nanocrystalline gold suspension that has achieved late-stage development for multiple sclerosis, the agent has a first-in-class mechanism of action within the multiple sclerosis portfolios. According to GlobalData, a prominent data and analytics business, its market position would be as an adjuvant therapy to other existing medicines aimed at reducing multiple sclerosis progression.
- CNM-Au8 supports remyelination in multiple sclerosis patients with persistent optic neuropathy
- The Phase II trial's primary goals are to explore visual and neurological functions generated by remyelination and neuroprotection of the brain and spinal cord
- CNM-Au8 exhibits a good safety profile and has potential as an adjuvant therapy for patients who are already on disease-modifying therapies
Novel Treatment of Multiple Sclerosis with Persistent Optic Neuropathy
CNM-Au8 does not target disease progression or relapse rate, unlike currently marketed and late-stage pipeline multiple sclerosis treatments. The Phase II trial's primary goals are to explore visual and neurological functions generated by remyelination, as well as neuroprotection of the brain and spinal cord. The Visionary trial's topline results were reported to Clene in August 2022, demonstrating a significant increase in low contrast letter acuity compared to placebo (least squares mean difference of 3.13) after 48 weeks. The Visionary trial's updated results showed a significant improvement in multi-focal visual evoked potential across both eyes by a mean difference of 7.9%.New Treatment Supports Remyelination in Multiple Sclerosis Patients
Barbora Salcman, Neurology Analyst at GlobalData, comments: “It is refreshing to see a treatment whose primary purpose is not to improve the progression of the disease itself, but to support remyelination in multiple sclerosis patients. Improving nerve cell function and survival can help multiple sclerosis patients with a broad range of problems, such as vision improvement, as chronic vision problems are experienced by around one in five multiple sclerosis patients. In this subset, CNM-Au8, therefore, has promising potential as an adjacent therapy for patients who are already on disease-modifying therapies, especially as the agent exhibits a good safety profile, with common side effects being headache and upper respiratory infection.” While clinical evidence for CNM-Au8 appears promising, key opinion leaders (KOLs) interviewed by GlobalData are not convinced of the agent as of yet. They believe CNM-Au8 will be an interesting addition to the multiple sclerosis portfolio, but they would like to see additional mechanistic data and obvious overall advantages from the agent.
Multiple sclerosis - Symptoms - Causes - Diagnosis - Treatment
Multiple sclerosis can be a severely disabling autoimmune disease that affects the myelin or insulating layer of the nerve fibers and typically has remissions and relapses
Multiple sclerosis can be a severely disabling autoimmune disease that affects the myelin or insulating layer of the nerve fibers and typically has remissions and relapses
‘Promising results for CNM-Au8 as a novel therapy for multiple sclerosis with persistent optic neuropathy. The agent supports remyelination and has a good safety profile, making it a potential adjuvant therapy for patients already on disease-modifying therapies.’
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Salcman continues, “These sentiments may partly reflect the limited
the sample size of the Visionary trial, which achieved enrollment of only 72 patients out of an expected 150, due to the COVID-19 pandemic complications, leading to the pre-specified significance threshold at p=0.1 before the submission to the FDA. The Phase III study would therefore need to demonstrate strong mechanistic data for the KOLs to recommend the agent to their patients.”Source-Medindia
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