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CNM-Au8

Phase 2

Relapsing Multiple Sclerosis | Small molecule | Neurology |Clene Inc.|Last Updated: Dec 8, 2023

Target and mechanism

ModalitySmall molecule

Also known as CNMAu8

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment55

FDA Designations

ACCELERATED_APPROVAL

Clinical trial landscape

CNM-Au8 · 1 trial · 1 indication

Phase 2 1
NCT04626921A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple SclerosisRelapsing Multiple Sclerosis
COMPLETED55 Analytics
PHASE2COMPLETED
A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis
NCT0462692155
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Study Endpoints

Primary Endpoints

Change in Best-Corrected Low-Contrast Letter Acuity score.
2 years

Mean change in BC-LCLA from baseline to end of study across all eyes as measured by 2.5% low contrast Sloan Letter Chart.

Incidence of treatment-emergent AEs throughout the study.
2 years

Safety endpoint include incidence of treatment-emergent AEs.

Secondary Endpoints

Measure of neurological function assessed by a functional composite responder analysis.
2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Active treatment with 30 mg of CNM-Au8EXPERIMENTALHighly pure elemental Au nanocrystals are suspended in deionized water buffered with 0.546 mg/mL (6.5 mM) sodium bicarbonate (NaHCO3) concentrated up to 0.5 mg/mL (500 ppm) Au.

Interventions

NameTypeDescription
CNM-Au8DRUG30 mg of CNM-Au8
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Participants must have completed study CNMAu8.201. * Able to understand and give written informed consent. Exclusion Criteria: * Lack of treatment compliance during participation in the CNMAu8.201 (VISIONARY-MS) study. * Positive pregnancy test. * Any history of previous mal...

Countries:Australia
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Frequently asked questions about CNM-Au8

What is CNM-Au8 used for?

CNM-Au8 is an investigational small molecule being developed for amyotrophic lateral sclerosis (ALS) and relapsing multiple sclerosis. It is in Phase 2 clinical development for both neurological conditions. The drug is not approved by the FDA and remains under investigation in clinical trials.

Who makes CNM-Au8?

CNM-Au8 is developed by Clene Inc., a biopharmaceutical company traded on the Nasdaq under the ticker CLNN. Clene is conducting clinical trials of CNM-Au8 in Australia for ALS and relapsing multiple sclerosis.

What phase is CNM-Au8 in?

CNM-Au8 is in Phase 2 clinical development. It has been studied in completed and ongoing Phase 2 trials for amyotrophic lateral sclerosis and relapsing multiple sclerosis. The drug is investigational and has not received FDA approval.

What clinical trials is CNM-Au8 in?

CNM-Au8 has been studied in several clinical trials, including NCT04098406, a completed Phase 2 study in ALS with 45 participants, and NCT04626921, a completed Phase 2 study in relapsing multiple sclerosis with 55 participants. An active open-label extension trial, NCT05299658, is enrolling ALS patients.

Is CNM-Au8 the same as CNMAu8?

Yes, CNM-Au8 and CNMAu8 refer to the same investigational drug. The name is written with and without a hyphen in clinical trial records and publications. Both names identify the same small molecule being developed by Clene Inc.