Clene, Inc. posted new data from a Phase II trial of CNM-AU8 in multiple sclerosis featuring MRI results it claims reinforce neurological improvements reported in November 2022.
Rob Etherington, CEO of Clene/Courtesy photo
Salt Lake City-based Clene, Inc. posted new data Monday from a Phase II trial of CNM-AU8 in multiple sclerosis featuring MRI results it claims reinforce neurological improvements originally reported in August 2022.
CNM-AU8, a gold nanocrystal oral therapy, is in development to restore brain health and function by increasing production of ATP, the body’s energy currency. CNM-AU8 is being tested as a disease-modifying treatment for MS, ALS and Parkinson’s disease.
The MRI data is part of a series of paraclinical biomarkers Clene is studying to understand the clinical effect that has been shown in MS.
In an interview with BioSpace, Rob Etherington, CEO, said what excites him most is that “the totality of evidence in defense of CNM-AU8 is just increasing...We’re here looking at quantitative evidence of, effectively, brain physiological remodeling.”
He explained that Clene is using MRI “to understand how water is moving in the brain across the neurons.”
The MRI data showed structural integrity in the brain’s neurons, specifically in the white matter, according to Monday’s press release. Loss of integrity in white matter is associated with cognitive and functional decline for MS patients.
While placebo patients showed deterioration during the treatment period, data from the CNM-Au8-treated patients demonstrated preserved white matter and favorable results across all nine prespecified brain regions.
MRI results also showed improved myelin integrity – a key factor in MS. In disorders like MS, the immune system attacks the myelin sheath surrounding nerve fibers in the brain, optic nerves and spinal cord. Despite current treatments, patients continue to lose cognitive and functional abilities due to demyelination.
The new data “further reinforce our hypothesis that improving brain energetic metabolism results in improved neurological structure and function when CNM-Au8 is administered as adjunct to standard immunomodulatory disease-modifying MS therapies,” said Robert Glanzman, M.D., chief medical officer, Clene, in a prepared statement.
Initial Results from the Phase II VISIONARY-MS trial presented in August 2022 showed efficacy in multiple areas affecting daily life for MS patients – including low contrast vision, cognition, upper body function and walking. A majority of study participants (92%) were also on other disease-modifying therapies.
Clene hit a pandemic road bump felt by many companies, enrolling only 73 patients in the study, less than half of its targeted 150.
While placebo-treated patients generally worsened across clinical and paraclinical measures during the 48-week period, those on CNM-Au8 showed consistent improvements across paraclinical biomarkers in addition to neurological improvement as assessed by the Multiple Sclerosis Functional Composite.
A Phase III trial will seek to “demonstrate improved global neurological function in patients with progression independent of relapse activity,” Glanzman said, calling this “the most urgent unmet need in MS today.”
The company plans to embark on a collaboration for this next step.
Clene is “open to” and “interested” in acquiring a partner to help the company develop the asset, Etherington said.
Clene plans to release more data pertaining to the VISIONARY-MS trial in the coming months, which will culminate in a package to be submitted to the FDA ahead of an end-of-Phase II meeting.
