Clene Presents Evidence of Remyelination and Neuronal Repair With CNM-Au8® Treatment At the American Academy of Neurology Late-Breaking Science Session
Clene (NASDAQ: CLNN) has presented new evidence of remyelination and neuronal repair in Multiple Sclerosis (MS) patients treated with CNM-Au8® from the VISIONARY-MS Trial long-term extension study. The findings, presented at the AAN 2025 Annual Meeting, demonstrate significant improvements in cognition and visual function.
Key results show that over 90% of participants who experienced improvements in cognition and vision also showed corresponding improvements in MRI and visual electrophysiology tests. Specifically, 96% of LCLA responders showed improvement in MRI DTI metrics, 91% exhibited mf-VEP improvements, and 98% of SDMT responders demonstrated improvements in MRI DTI AD and/or MTR metrics.
The study validates CNM-Au8's therapeutic mechanism in supporting critical repair processes within neurons and oligodendrocytes, leading to improved neurological function and remyelination. These results are consistent with previous findings from the double-blind period of the trial.
Clene (NASDAQ: CLNN) ha presentato nuove evidenze di remielinizzazione e riparazione neuronale in pazienti affetti da Sclerosi Multipla (SM) trattati con CNM-Au8® nel lungo studio di estensione del Trial VISIONARY-MS. I risultati, presentati all'AAN 2025 Annual Meeting, dimostrano significativi miglioramenti nella cognizione e nella funzione visiva.
I risultati chiave mostrano che oltre il 90% dei partecipanti che hanno sperimentato miglioramenti nella cognizione e nella visione hanno mostrato anche corrispondenti miglioramenti nei test di risonanza magnetica (MRI) e di elettrofisiologia visiva. In particolare, il 96% dei rispondenti LCLA ha mostrato un miglioramento nei parametri DTI della MRI, il 91% ha evidenziato miglioramenti nel mf-VEP, e il 98% dei rispondenti SDMT ha dimostrato miglioramenti nei parametri AD e/o MTR della MRI DTI.
Lo studio convalida il meccanismo terapeutico di CNM-Au8 nel supportare i processi di riparazione critici all'interno dei neuroni e degli oligodendrociti, portando a un miglioramento della funzione neurologica e alla remielinizzazione. Questi risultati sono coerenti con le scoperte precedenti del periodo in doppio cieco dello studio.
Clene (NASDAQ: CLNN) ha presentado nuevas evidencias de remielinización y reparación neuronal en pacientes con Esclerosis Múltiple (EM) tratados con CNM-Au8® del estudio de extensión a largo plazo del ensayo VISIONARY-MS. Los hallazgos, presentados en la Reunión Anual AAN 2025, demuestran mejoras significativas en la cognición y la función visual.
Los resultados clave muestran que más del 90% de los participantes que experimentaron mejoras en la cognición y la visión también mostraron mejoras correspondientes en pruebas de MRI y electrofisiología visual. Específicamente, el 96% de los respondedores LCLA mostró mejoras en las métricas DTI de MRI, el 91% exhibió mejoras en mf-VEP, y el 98% de los respondedores SDMT demostró mejoras en las métricas AD y/o MTR de MRI DTI.
El estudio valida el mecanismo terapéutico de CNM-Au8 en el apoyo a procesos críticos de reparación dentro de neuronas y oligodendrocitos, lo que conduce a una mejora en la función neurológica y la remielinización. Estos resultados son consistentes con hallazgos previos del período doble ciego del ensayo.
클레네 (NASDAQ: CLNN)은 VISIONARY-MS 시험의 장기 연장 연구에서 CNM-Au8®로 치료받은 다발성 경화증 (MS) 환자에서 재미엘리네이션 및 신경 회복에 대한 새로운 증거를 제시했습니다. AAN 2025 연례 회의에서 발표된 이 결과는 인지 및 시각 기능의 유의미한 개선을 보여줍니다.
주요 결과는 90% 이상의 참가자가 인지 및 시각에서 개선을 경험한 경우 MRI 및 시각 전기생리학 테스트에서도 상응하는 개선을 보였음을 보여줍니다. 구체적으로, LCLA 응답자의 96%가 MRI DTI 지표에서 개선을 보였고, 91%가 mf-VEP 개선을 보였으며, SDMT 응답자의 98%가 MRI DTI AD 및/또는 MTR 지표에서 개선을 나타냈습니다.
이 연구는 CNM-Au8의 치료 메커니즘이 신경세포 및 희소돌기아교세포 내에서 중요한 회복 과정을 지원하여 신경 기능 개선 및 재미엘리네이션으로 이어짐을 확인합니다. 이러한 결과는 시험의 이중 맹검 기간에서의 이전 발견과 일치합니다.
Clene (NASDAQ: CLNN) a présenté de nouvelles preuves de remyélinisation et de réparation neuronale chez des patients atteints de sclérose en plaques (SEP) traités avec CNM-Au8® dans l'étude d'extension à long terme de l'essai VISIONARY-MS. Les résultats, présentés lors de la réunion annuelle de l'AAN 2025, montrent des améliorations significatives de la cognition et de la fonction visuelle.
Les résultats clés montrent que plus de 90% des participants ayant constaté des améliorations de la cognition et de la vision ont également présenté des améliorations correspondantes dans les tests d'IRM et d'électrophysiologie visuelle. Plus précisément, 96% des répondants LCLA ont montré une amélioration des métriques DTI de l'IRM, 91% ont montré des améliorations dans le mf-VEP, et 98% des répondants SDMT ont démontré des améliorations dans les métriques AD et/ou MTR de l'IRM DTI.
L'étude valide le mécanisme thérapeutique de CNM-Au8 en soutenant des processus de réparation critiques au sein des neurones et des oligodendrocytes, conduisant à une amélioration de la fonction neurologique et à la remyélinisation. Ces résultats sont cohérents avec les découvertes précédentes de la période en double aveugle de l'essai.
Clene (NASDAQ: CLNN) hat neue Beweise für Remyelinisierung und neuronale Reparatur bei Patienten mit Multipler Sklerose (MS) vorgestellt, die im Rahmen der Langzeitverlängerungsstudie des VISIONARY-MS-Tests mit CNM-Au8® behandelt wurden. Die Ergebnisse, die auf dem AAN 2025 Annual Meeting präsentiert wurden, zeigen signifikante Verbesserungen in der Kognition und der visuellen Funktion.
Wichtige Ergebnisse zeigen, dass über 90% der Teilnehmer, die Verbesserungen in der Kognition und der Vision erfahren haben, auch entsprechende Verbesserungen in MRI- und visuell-elektrophysiologischen Tests zeigten. Insbesondere zeigten 96% der LCLA-Responder Verbesserungen in den MRI-DTI-Metriken, 91% wiesen Verbesserungen im mf-VEP auf, und 98% der SDMT-Responder demonstrierten Verbesserungen in den MRI-DTI-AD- und/oder MTR-Metriken.
Die Studie validiert den therapeutischen Mechanismus von CNM-Au8 zur Unterstützung kritischer Reparaturprozesse innerhalb von Neuronen und Oligodendrozyten, was zu einer verbesserten neurologischen Funktion und Remyelinisierung führt. Diese Ergebnisse stimmen mit früheren Erkenntnissen aus der doppelblinden Phase der Studie überein.
- Strong efficacy data with over 90% of participants showing improvements across multiple metrics
- Clinical improvements validated by objective biomarker measurements
- Successful demonstration of remyelination and neuronal repair, unique in MS clinical trials
- Consistent results between double-blind and long-term extension periods
- Phase 3 trial still required for final validation
- Results from open-label extension study may have inherent limitations compared to double-blind trials
Insights
Clene's presentation at the American Academy of Neurology provides compelling evidence that CNM-Au8 may represent a breakthrough in MS treatment through demonstrated remyelination and neuronal repair capabilities. This addresses a critical unmet need, as previous remyelination therapies have shown little to no success in MS.
What makes this data particularly strong is the multi-modal validation approach: clinical improvements (cognition and vision) aligned with both structural changes (MRI metrics) and functional improvements (visual evoked potentials). Specifically, over 90% of participants showing cognitive or visual improvements also demonstrated corresponding objective biomarker improvements.
The consistent correlation between subjective improvements and objective measurements provides substantial validation of CNM-Au8's mechanism of action. Most existing MS therapies focus on preventing further damage rather than repairing existing neuronal injury, positioning Clene's approach as potentially transformative.
This represents a significant advancement in the company's clinical development program, with plans for a global Phase 3 trial indicating confidence in the reproducibility of these findings. The robust data package presented at this prestigious late-breaking session suggests Clene has potentially overcome the hurdles that have plagued previous remyelination candidates.
Clene's presentation delivers exactly what investors seek in clinical-stage biotech: compelling efficacy signals with objective biomarker validation. The dual confirmation of both anatomical (MRI) and physiological (VEP) improvements provides a robust evidence package rarely seen in MS trials focused on repair.
Three aspects particularly stand out from an investment perspective: First, the 96% correlation between visual improvements and MRI changes demonstrates CNM-Au8's mechanism is working as theorized. Second, the 98% correlation between cognitive improvements and structural changes validates potential broader neurological benefits. Third, the consistent results from the double-blind period through the extension study suggest durable treatment effects.
This positions Clene advantageously in the competitive MS landscape, where most approved therapies focus on inflammation rather than repair. With the MS market valued at over $25 billion annually and growing, a therapy demonstrating true remyelination potential addresses a significant unmet need and commercial opportunity.
The advancement to a planned global Phase 3 trial represents a critical value-inflection point. While development and regulatory risks remain, these results significantly de-risk the CNM-Au8 program by providing strong proof-of-concept for Clene's core technology platform, potentially supporting applications in other neurodegenerative conditions like ALS, where the company is also pursuing development.
- Analyses of MRI and VEP data confirm anatomical and physiological improvements, indicating remyelination and neuronal repair in the brains of MS patients treated with CNM-Au8 during the long-term extension of VISIONARY-MS
- Over
90% of participants who showed improvements in cognition and vision also demonstrated corresponding improvements on MRI and visual electrophysiology tests
SALT LAKE CITY, April 08, 2025 (GLOBE NEWSWIRE) -- Clene, Inc. (Nasdaq: CLNN) and its subsidiary, Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company dedicated to advancing therapies for neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced new evidence of remyelination and neuronal repair in MS participants following treatment with CNM-Au8® 30 mg from analyses of the VISIONARY-MS Trial long-term open-label extension study. The post hoc analyses identify consistent anatomical and physiologic effects within the same study participants resulting in cognition and vision improvement for people living with MS.
The presentation at the AAN 2025 Annual Meeting (San Diego, CA) today in the Late Breaking Science Session 2, “Physiologic and Anatomical Evidence of Neuronal Repair and Remyelination from the Long-Term Open-Label Extension of the Phase 2 VISIONARY-MS Trial,” highlights significant and clinically meaningful improvements in cognition and visual function, supported by corresponding objective biomarkers, including advanced MRI Diffusion Tensor Imaging (DTI) and multi-focal Visual Evoked Potential (mf-VEP) assessments.
Key findings from the analyses of the long-term VISIONARY-MS trial extension included:
- MRI DTI metrics (Axial Diffusivity (AD) and Magnetization Transfer Ratio (MTR) —structural markers associated with neuronal repair and remyelination) confirmed improvements in the brain’s neuronal structure consistent with remyelination and repair among MS participants receiving CNM-Au8
- mf-VEP metrics (VEP latency and amplitude—functional markers associated with remyelination and neuronal repair) confirmed improvements in the visual system and related to cognitive function among MS participants receiving CNM-Au8
Both the LCLA (low contrast letter acuity) vision—a visual measure associated with vision-specific quality of life and overall MS disability, and SDMT (symbol digit modality test)—a benchmark for working memory and cognitive processing speed in MS—improved in CNM-Au8 participants, results that have not been previously documented in MS clinical trials of other repair candidate drugs.
Importantly, these clinical improvements correlated with objective biomarker measurements including:
96% of participants who were LCLA responders, showing visual improvement, also demonstrated improvement in MRI DTI metrics (AD and/or MTR), evidencing repair and remyelination91% of LCLA visual responders exhibited mf-VEP Improvements in Latency (conduction velocity) and/or Amplitude (signal strength)- VEP provides an objective measure of visual circuit pathway, further supporting functional recovery linked to repair and remyelination
- VEP provides an objective measure of visual circuit pathway, further supporting functional recovery linked to repair and remyelination
98% of SDMT responders with improved cognition had corresponding improvements in MRI DTI AD and/or MTR metrics, substantiating that the cognitive enhancement was associated with repair and remyelination
These results are also consistent with previous neuronal and clinical improvement observed in the double-blind period of the VISIONARY-MS trial, while also reinforcing the long-term benefits of the novel therapeutic mechanism of CNM-Au8. CNM-Au8 supports critical repair processes within neurons and oligodendrocytes, leading to improved neurological function and remyelination, as previously documented.
“For years there have been attempts to test potential remyelination therapies in MS with little to no success. Even for interventions that yielded nominal changes in MRI or physiology measures, there was a lack of consistent, robust clinical benefits to participants. These results underscore the fact that CNM-Au8 treatment in the Phase 2 VISIONARY-MS Trial not only led to clinical improvements, but also demonstrates that these observed clinical benefits resulted from underlying tissue repair and evidence of remyelination,” stated Ben Greenberg, MS expert and Head of Medical for Clene. “We look forward to confirming these data in a global Phase 3 trial.”
About Clene
Clene Inc., (Nasdaq: CLNN) (along with its subsidiaries, “Clene” and its wholly owned subsidiary Clene Nanomedicine, Inc.), is a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis, Parkinson’s disease, and multiple sclerosis. CNM-Au8® is an investigational first-in-class therapy that improves central nervous system cells’ survival and function via a mechanism that targets mitochondrial function and the NAD pathway while reducing oxidative stress. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc. The company is based in Salt Lake City, Utah, with R&D and manufacturing operations in Maryland. For more information, please visit www.clene.com or follow us on X (formerly Twitter) and LinkedIn.
About CNM-Au8®
CNM-Au8 is an oral suspension of gold nanocrystals developed to restore neuronal health and function by increasing energy production and utilization. The catalytically active nanocrystals of CNM-Au8 drive critical cellular energy producing reactions that enable neuroprotection and remyelination by increasing neuronal and glial resilience to disease-relevant stressors. CNM-Au8® is a federally registered trademark of Clene Nanomedicine, Inc.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, which are intended to be covered by the “safe harbor” provisions created by those laws. Clene’s forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding our future operations. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would,” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements represent our views as of the date of this press release and involve a number of judgments, risks and uncertainties. We anticipate that subsequent events and developments will cause our views to change. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date. As a result of a number of known and unknown risks and uncertainties, our actual results or performance may be materially different from those expressed or implied by these forward-looking statements. Some factors that could cause actual results to differ include our ability to demonstrate the efficacy and safety of our drug candidates; the clinical results for our drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; our ability to achieve commercial success for our drug candidates, if approved; our limited operating history and our ability to obtain additional funding for operations and to complete the development and commercialization of our drug candidates; and other risks and uncertainties set forth in “Risk Factors” in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and you are cautioned not to rely unduly upon these statements. All information in this press release is as of the date of this press release. The information contained in any website referenced herein is not, and shall not be deemed to be, part of or incorporated into this press release.
| Media Contact Ignacio Guerrero-Ros, Ph.D., or David Schull Russo Partners, LLC Ignacio.guerrero-ros@russopartnersllc.com David.schull@russopartnersllc.com (858) 717-2310 | Investor Contact Kevin Gardner LifeSci Advisors kgardner@lifesciadvisors.com (617) 283-2856 |
FAQ
What are the key findings of CLNN's VISIONARY-MS Trial extension study for CNM-Au8?
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