NOW RECRUITING: PHASE 2 CLINICAL TRIAL
Have you or a loved one been diagnosed with OHE?
(overt hepatic encephalopathy)
You or your loved one could be eligible to participate in a clinical trial of an investigational treatment for OHE.
OHE is a serious medical condition that affects how the brain and nerves work. People with OHE can become very confused and may be unable to care for themselves. This condition can lead to hospitalization, coma and even death.
About the EMMPOWER Phase 2 Clinical Trial in Subjects Who Have Experienced OHE
EMMPOWER (#NCT04816916) is being conducted to investigate the effectiveness and safety of AXA1665, an investigational (not approved) new drug that is administered as a drink for subjects who have recently experienced an OHE episode.
EMMPOWER will seek to determine if AXA1665 is able to reduce the risk of OHE episodes and improve thought processing in subjects who have a history of OHE. Additionally, the trial will investigate AXA1665’s potential to prevent muscle loss and improve the ability to perform physical activities without assistance.
The trial compares AXA1665 versus a placebo over a 24-week study treatment period and a four-week safety follow-up period. Approximately 150 subjects are being enrolled across more than 70 clinical sites worldwide.
Subjects who participate in EMMPOWER will be able to continue taking their current OHE treatments (lactulose and/or rifaximin) and will receive:
AXA1665 for 24 weeks if assigned to the active study drug (half of subjects to receive active study drug)
Trial-related monitoring and care from a physician who has experience with cirrhosis and OHE
Trial-related medical tests
- Be at least 18 years of age
- Have a history of cirrhosis and at least one documented OHE episode within the past 6 months
- Have a caregiver who is able to support them during the trial
- Have other serious complications of cirrhosis (i.e., kidney failure, fluid retention in the stomach, infection)
- Have other neurologic conditions, such as Alzheimer’s disease or Parkinson’s disease
- Drink excessive alcohol
OHE is a serious medical condition that affects how the brain and nerves work. People with OHE can become confused to the point where they are unable to care for themselves. This condition can lead to hospitalization, coma and even death.
OHE results from an advanced liver disease called cirrhosis. The human liver plays an essential role in filtering toxins, such as ammonia, out of the bloodstream. In patients with cirrhosis, toxins build up in the body and travel to the brain, impairing thinking and causing confusion, among a host of other symptoms. Additionally, many patients with cirrhosis experience muscle wasting (known as sarcopenia) that can be rapid and severe as the muscle tries to help clear toxins from the body.
It is estimated that up to 50% of patients with cirrhosis will develop hepatic encephalopathy. This can range from a milder form of the condition, known as minimal or covert hepatic encephalopathy, to the most severe and apparent form, known as overt hepatic encephalopathy (OHE). While OHE usually lasts for a period of hours or days, patients can experience frequent episodes, and they tend to be impaired to the point where they are unable to care for themselves and often must be hospitalized.
Currently, there are limited medications approved for OHE. Even when taking these therapies, many patients continue to experience breakthrough OHE episodes.
Symptoms of OHE
- Lack of energy, attention and interest
- Significant personality changes
- Shaking hands
- Worsened handwriting
- Breath that smells musty or sweet
AXA1665 is a proprietary mixture of eight amino acids, which are small molecules that make up the building blocks of proteins in the body. Amino acids are a normal part of the human diet and naturally influence many of the body's systems.
AXA1665 is a dry powder agent that is simply mixed with a small amount of water and drank by the subject. The EMMPOWER trial is seeking to determine this product candidate’s ability to work with the body’s system to improve thinking, reduce OHE events, and improve muscle function in subjects who have a history of OHE. The trial also will investigate safety and tolerability versus a placebo.
AXA1665 is an investigational new drug that has not been approved for the treatment of OHE by any regulatory authority.
The EMMPOWER trial is being conducted globally across more than 70 clinical sites.