How does CNM-Au8 help with ALS?

CNM-Au8 is an experimental therapy that is still in clinical testing as a potential treatment for amyotrophic lateral sclerosis (ALS). It is made of gold nanocrystals designed to support the energetic needs of nerve cells and help to remove toxic molecules from cellular metabolism, reducing nerve cell damage. In clinical trials, the treatment significantly slowed disease progression and the risk of reaching multiple disease milestones, and improved survival in ALS patients.

When will the FDA approve CNM-Au8?

As Phase 2 clinical trials testing CNM-Au8 have shown promising results in people with amyotrophic lateral sclerosis (ALS), Clene Nanomedicine, the company developing CNM-Au8, now is planning to launch a Phase 3 trial to confirm the benefits of the liquid suspension in a larger population of patients. Data from this trial, called RESTORE-ALS, may support an application to the U.S. Food and Drug Administration, but it is still too early to know if or when the medication might be approved.

What are the potential side effects of CNM-Au8?

The most common side effects deemed related to CNM-Au8 in clinical trials involving people with amyotrophic lateral sclerosis included aspiration pneumonia, nausea, bruising, and abdominal discomfort. No serious side effects deemed related to treatment have been reported. Patients should speak with their healthcare team to know more about which side effects could be expected when beginning treatment with CNM-Au8.

Can I drink alcohol while taking CNM-Au8?

Because CNM-Au8 is still in the early stages of development, studies examining its interaction with alcohol are still lacking. It is recommended that patients discuss this issue with their doctors to know if it is safe to drink alcohol while on this therapy.

How long should I wait to see the results of CNM-Au8?

In the CNM-Au8 arm of the HEALEY ALS trial, significant improvements in multiple measures of disease progression and survival were seen as early as six months after beginning treatment. However, the exact timing for experiencing an effect from CNM-Au8 is unknown, as it can vary from patient-to-patient. A conversation with a healthcare provider may help patients better understand when CNM-Au8 may have an effect in their specific case.

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