Clene Inc. Reports ‘Unprecedented,’ Statistically Significant Long-Term Clinical Improvements for VISIONARY-MS Trial Participants with Stable Relapsing-Remitting MS

February 8, 2024

• Clene recently reported new results from the open-label, long-term extension (“LTE”) of the VISIONARY-MS trial, involving participants with stable relapsing Multiple Sclerosis (“MS”) through week 144 (over 2.75 years) after the initial randomization
• Results from the 48-week double-blind period showed statistically significant improvements in vision (primary endpoint), as well as a combined improvement in cognition, walking speed, upper extremity function, and vision (secondary endpoint) with CNM-Au8 treatment, with further significant improvements in both vision and cognition extending throughout the 96-week LTE
• One of the trial’s key clinical advisors hailed the results as robust and consistent, describing the observed long-term clinical improvements as unprecedented
• Data from both the double-blind trial period and the LTE build a strong case for pursuing CNM-Au8(R) in upcoming Phase 3 studies, said Dr. Benjamin Greenberg, Head of Medicine at Clene

Clene (NASDAQ: CLNN) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, recently reported new results from the open-label long-term extension (“LTE”) of the VISIONARY-MS trial (https://ibn.fm/5QSDO). This was a double-blind, placebo-controlled Phase 2 clinical trial comprised of participants with chronic optic neuropathy associated with stable relapsing Multiple Sclerosis (“RMS”).

About Multiple Sclerosis

RMS is a disease of the central nervous system in which the body’s own immune system attacks myelin in the brain (the protective sheath that covers and protects nerve fibers). These attacks disrupt communication between the brain and the rest of the body (https://ibn.fm/2oZZU). About 80-90% of people with MS are diagnosed with RMS. A person with this type of MS experiences episodes of new or worsening symptoms, known as relapses, that often occur without warning. The symptoms of RMS include difficulties with vision, trouble with balance, numbness particularly in the feet, weakness, fatigue, difficulty thinking clearly, lack of coordination, need to urinate urgently and frequently, and depression (https://ibn.fm/YPMI8). Several FDA-approved disease-modifying treatments (“DMTs”) for relapsing MS are now available and have been shown to effectively suppress relapses. Despite these drugs, continued disease progression in MS occurs, and no drug currently on the market has been shown to recover function once function has been lost.

Optic neuritis is often associated with MS. Optic neuritis in MS occurs when the optic nerve is damaged by inflammation. The optic nerve carries messages from the eye to the brain and enables our brain to process and interpret what we see. Visual impairments associated with MS can be measured using a special eye chart in which grayed-out letters appear on a white background. The number of letters a person can accurately identify on the eye chart is a measure of low contract letter acuity.

VISIONARY-MS Trial

In order to help MS patients, Clene initiated the VISIONARY-MS trial to investigate the protection or improvement of neurological function following the administration of the company’s CNM-Au8(R) as a potentially remyelinating and neuro-reparative treatment. 92% of all participants in the trial continued the use of highly effective immunomodulatory disease-modifying therapies as background standard of care. As part of the study, participants drank a dose of CNM-Au8 (15 or 30 mg) or placebo daily over 48 weeks.

The trial’s primary outcome was low contrast visual acuity (“LCLA”), an assessment of visual function, or how well people living with optical neuritis caused by their MS can see. Global neurological improvement, measured by modified Multiple Sclerosis Functional Composite (“mMSFC”), which is comprised of assessments for vision, cognition (working memory and processing speed), fine motor dexterity, and walking speed, was the secondary outcome.

Long-Term Open-Label Extension

After completion of the 48-week treatment period, study participants were offered the opportunity to continue receiving CNM-Au8 30 mg for up to nearly two additional years in the LTE. Most placebo participants chose to participate and transitioned to CNM-Au8 for the LTE. Clene announced topline results from the double-blind period of VISIONARY-MS in Q3 2022, and then a few weeks ago announced results from the LTE, which covered assessments conducted through the total of week 144 (35 months after the initial randomization). The company reported analyses for the modified intent to treat (“mITT”) population that included all study participants with valid clinical data.

The results from the LTE included:

• Statistically significant (p < 0.0001) progressive vision improvement as measured by LCLA through week 144 as compared to the original randomization baseline
• Statistically significant (p < 0.0001) progressive cognitive improvement as measured by the Symbol Digit Modality Test (“SDMT”) through week 144 as compared to the original randomization baseline

According to these trial data, placebo patients who transitioned to CNM-Au8 during the LTE showed significant improvements (compared to the original baseline in LCLA and SDMT) after switching to active drug that were consistent with the increases observed in participants originally randomized to CNM-Au8. Moreover, Clene reported that the improvements demonstrated during the initial 48-week treatment period were maintained in the LTE for the timed 25-foot walk test (“T25FWT”), a part of the mMSFC that assessed walking speed, and the nine-hole peg test (“9HPT”), a part of the mMSFC which is used for assessing upper extremity function.

“These observed long-term clinical improvements for participants with stable disease, over and above background immunomodulatory disease-modifying therapy, are unprecedented,” shared Professor Michael Barnett, one of the trial’s key clinical advisors. “The data show clear overall improvements in vision and cognition for participants treated for nearly three years from randomization. Importantly, these results were robust and consistent. Positive impacts on disease progression and the potential to at least partially reverse established disability, if confirmed in a larger study, represent a major therapeutic leap for patients with MS.”

According to Benjamin Greenberg, M.D., Head of Medicine at Clene, the data from the 48-week double-blind period and the 96-week LTE continue to strongly support efforts to pursue CNM-Au8 in upcoming Phase 3 studies. “Clinically significant improvement is rarely seen in MS patients and this trial provides evidence of CNM-Au8’s potential to improve function in this population. Clene is currently reviewing these data with prospective pharmaceutical partners interested in MS,” added Greenberg.

Clene expects to present the full clinical results for the LTE at the ninth annual Americas Committee for Treatment and Research in Multiple Sclerosis (“ACTRIMS”) Forum scheduled for February 29 – March 2, 2024, in West Palm Beach, Florida.

The gold nanocrystal suspension, CNM-Au8, is an investigational first-in-class therapy with neuroprotective and neuroreparative properties attributed to the nanocrystals’ ability to catalytically improve energetic metabolism in central nervous system cells. Clene is currently developing CNM-Au8 as a disease-modifying treatment for people living with Amyotrophic Lateral Sclerosis (“ALS”), Parkinson’s Disease, and MS.

For more information, visit the company’s website at www.Clene.com.

NOTE TO INVESTORS: The latest news and updates relating to CLNN are available in the company’s newsroom at https://ibn.fm/CLNN

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