Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CNMAu8 · 2 trials · 1 indication
Safety endpoints include incidence of treatment-emergent AEs, drug-related AEs, deaths, SAEs, and AEs leading to discontinuation from the study. Changes from baseline (Week 36 of the placebo controlled phase) in clinical laboratory results, physical examination findings, vital signs, ECGs, and C-SSRS will be summarized descriptively by group and timepoint.
Mean change in the average difference between active treatment and placebo from Baseline through End of Study for the MUNIXscore(4), which is the sum of the respective MUNIX values for the Abductor Digiti Minimi (ADM), Abductor Pollicis Brevis (APB), Biceps Brachii (BB), and Tibialis Anterior (TA).
The Motor Unit Number Index (MUNIX) is a quantitative neurophysiological measure that provides an index of the number of lower motor neurons supplying a muscle. It reflects the loss of motor neurons in patients with ALS. Mean change in the average difference between active treatment and placebo from Baseline through Week 36 for the MUNIXscore(4), which is the sum of the respective MUNIX values for the Abductor Digiti Minimi (ADM), Abductor Pollicis Brevis (APB), Biceps Brachii (BB), and Tibialis Anterior (TA). The average baseline summed values will be indexed to 100%. Changes will be calculated as the percent change from the Baseline index of 100%.
| Arm | Type | Description |
|---|---|---|
| Open label extension | EXPERIMENTAL | This is an unblinded open-label extension, all participants will be on active drug. |
| Placebo | PLACEBO_COMPARATOR | The matched placebo used in this study consisted of water, sodium bicarbonate, and food coloring to match volume and color of the experimental treatment |
| 30 mg CNM-Au8 | EXPERIMENTAL | 30mg suspension of clean-surfaced, faceted, gold nanocrystals in 60ml of sodium bicarbonate buffered water |
| Name | Type | Description |
|---|---|---|
| CNMAu8 | DRUG | CNM-Au8 is an aqueous suspension of clean surfaced faceted nanocrystals consisting of gold atoms self-organized into crystals of various geometrical shapes (hexagonal bi-pyramid, pentagonal bi-pyramid, tetrahedron, decahedron, planar spheroids). Those choosing to participate in the OLE period will orally receive 30 mg of CNM-Au8, once daily. |
| CNM-Au8 | DRUG | CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a nominal concentration of 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose 60 mL HDPE containers. |
| Placebo | DRUG | Placebo was liquid with identical color and taste |
Inclusion Criteria: 1. Participants must have completed the randomized placebo-controlled Treatment Period without compliance issues. 2. Able to understand and give written informed consent to participate in the open-label extension. 3. If referred from a third party (neurologist or a State based A...
CNM-Au8 is an investigational small molecule being studied for relapsing multiple sclerosis and amyotrophic lateral sclerosis (ALS). It is in Phase 2 clinical development and has not been approved by the FDA. The drug is being evaluated for its potential to slow disease progression in these neurological conditions.
CNM-Au8 is being developed by Clene Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLNN. The company is conducting clinical trials of CNM-Au8 in Australia for both amyotrophic lateral sclerosis and relapsing multiple sclerosis.
CNM-Au8 is in Phase 2 clinical development. It has received FDA accelerated approval designation, but it remains investigational and is not yet approved for commercial use. The drug is being studied in patients with amyotrophic lateral sclerosis and relapsing multiple sclerosis.
CNM-Au8 has been studied in three clinical trials. NCT04098406 was a completed Phase 2 study in ALS with 45 patients. NCT04626921 was a completed Phase 2 long-term extension study in relapsing multiple sclerosis with 55 patients. NCT05299658 is an active Phase 2 open-label extension study in early symptomatic ALS with 40 patients.
Yes, CNM-Au8 is also known as CNMAu8. Both names refer to the same investigational drug being developed by Clene Inc. for the treatment of amyotrophic lateral sclerosis and relapsing multiple sclerosis.
CNM-Au8 is a small molecule therapeutic nanocatalyst designed to enhance cellular bioenergetics. It is being studied for its potential to slow disease progression in ALS and relapsing multiple sclerosis by supporting energy production in cells. The exact mechanism of action is not fully detailed in available information.