NB-4746 for ALS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how a new treatment, NB-4746, affects people with amyotrophic lateral sclerosis (ALS) compared to a placebo. Researchers focus on identifying any side effects, how the body processes the drug, and changes in a blood marker that indicates nerve damage. The trial consists of two parts, each testing different doses of NB-4746 or a placebo, and includes an optional extension for continued treatment. It seeks participants diagnosed with ALS who first noticed symptoms like limb or speech weakness within the last two years. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but if you are taking riluzole or edaravone, you must be on a stable dose for a certain period before starting the trial. It's best to discuss your current medications with the trial doctors to get specific guidance.
Is there any evidence suggesting that NB-4746 is likely to be safe for humans?
Research has shown that NB-4746 is a new treatment under study for amyotrophic lateral sclerosis (ALS). Early studies suggest that this drug aims to protect brain cells. Although detailed safety information remains limited, NB-4746 has undergone initial human trials. These trials represent the first step in testing any new treatment in people, focusing on ensuring its safety.
NB-4746 is taken as a capsule, and studies have demonstrated that the body can absorb it. This absorption is intended to allow the drug to reach the brain, where it may help protect nerve cells. So far, no specific information is available on serious side effects in humans from these studies. However, researchers are closely monitoring for any problems or unwanted effects, as with any new treatment.
Since the study is in an early phase, researchers continue to carefully assess safety in humans. They are gathering data to ensure that NB-4746 is well-tolerated and does not cause harmful side effects. This process is a normal and important part of developing any new treatment.12345Why do researchers think this study treatment might be promising?
Researchers are excited about NB-4746 for ALS because it represents a fresh approach to tackling the disease. Unlike current treatments like riluzole and edaravone, which focus on slowing disease progression, NB-4746 is believed to target the underlying mechanisms of ALS more directly. This treatment stands out due to its potential new mechanism of action, offering hope for more effective symptom management and improved quality of life. Furthermore, the trial explores different dosing strategies to determine the most beneficial approach, which could lead to more personalized treatment options for patients.
What evidence suggests that NB-4746 might be an effective treatment for ALS?
Research has shown that NB-4746 might help treat amyotrophic lateral sclerosis (ALS). Earlier studies found that NB-4746 lowers levels of neurofilament light (NfL), a marker of nerve cell damage. By reducing NfL, NB-4746 may protect nerve cells from harm. This is crucial because, in ALS, nerve cells suffer damage, leading to muscle weakness and other symptoms. Early tests in lab models also demonstrated that NB-4746 can significantly reduce nerve damage. While these results are promising, further studies are needed to confirm NB-4746's effectiveness in people with ALS. Participants in this trial will receive either a high dose or low dose of NB-4746, or a placebo, to further evaluate its effectiveness.13678
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 diagnosed with ALS within the last 2 to 4 years, who can still swallow fairly well and have good lung function. Participants must be willing to use contraception and have stable lab results. Those on riluzole or edaravone need to be on a steady dose before joining.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part A Treatment
Participants receive NB-4746 or placebo capsules twice daily for 1 month
Part B Treatment
Participants receive NB-4746 or placebo capsules twice daily for 12 weeks
Open-Label Extension
Participants may opt into continuation of treatment for up to 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NB-4746
Trial Overview
The study tests different doses of an experimental drug called NB-4746 against a placebo in people with ALS. Treatment is taken by mouth twice daily over several weeks, with some participants able to continue treatment for up to one year if they choose.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive two NB-4746 capsules (low dose), BID
Participants will receive two NB-4746 capsules (high dose), BID
Participants will receive two capsules of NB-4746 (dose selected after review of Ph 1b data), BID
Participants will receive two capsules of placebo per dose, BID.
Participants will receive two capsules of placebo, BID
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nura Bio
Lead Sponsor
Citations
A Clinical Trial to Evaluate NB-4746 in Participants With ...
The purpose of this trial is to learn about the effects of NB-4746 compared with placebo in people with amyotrophic lateral sclerosis.
2.
pharmaceutical-technology.com
pharmaceutical-technology.com/data-insights/nb-4746-nura-bio-amyotrophic-lateral-sclerosis-likelihood-of-approval-2/NB-4746 by Nura Bio for Amyotrophic Lateral Sclerosis
According to GlobalData, Phase I drugs for Amyotrophic Lateral Sclerosis have an 81% phase transition success rate (PTSR) indication benchmark ...
ANZCTR - Registration
To evaluate potential drug-drug interactions of NB-4746 with CYP1A2 (caffeine) and CYP3A4 (midazolam) substrates in healthy volunteers. Query!
Nura Bio initiates trial of NB-4746 to treat neurological ...
NB-4746 has also reduced and, in some cases, prevented levels of neurofilament light (NfL), the axonal injury-dependent disease-associated ...
Current and emerging treatments for amyotrophic lateral ...
Results from population-based studies indicated that riluzole therapy increased survival rates at 12 months by approximately 10% and prolonged survival by 4โ6 ...
6.
nurabio.com
nurabio.com/news/nura-bio-initiates-phase-1-clinical-trial-for-its-oral-brain-penetrant-sarm1-inhibitor-nb-4746/Nura Bio Initiates Phase I Clinical Trial for its Oral, Brain ...
NB-4746 is believed to be a first-in-class, oral, brain-penetrant, neuroprotective SARM1 inhibitor with broad therapeutic potential across diseases.
Safety and Efficacy of PrimeC in Amyotrophic Lateral ...
Importance: Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease with limited treatment options. PrimeC is a fixed-dose oral ...
8.
pharmaceutical-technology.com
pharmaceutical-technology.com/data-insights/nb-4746-nura-bio-amyotrophic-lateral-sclerosis-likelihood-of-approval/NB-4746 by Nura Bio for Amyotrophic Lateral Sclerosis
According to GlobalData, Phase I drugs for Amyotrophic Lateral Sclerosis have an 87% phase transition success rate (PTSR) indication benchmark ...
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