Nonalcoholic Steatohepatitis (NASH) is a rare disease in which hepatic inflammation and injury to the cells occur as a result of steatosis (hepatic fat accumulation).
Severe cases of NASH can lead to cirrhosis, hepatocellular carcinoma, and end stage liver disease.
What causes NASH? It is often linked to the combination of unhealthy food habits and a minimal amount of physical activity.
Unfortunately, there are currently no treatments approved for NASH. Patients do have options to treat some of the comorbidities associated with the disease such as cardiovascular disease, type 2 diabetes, and obesity, however there is no therapy for NASH itself. Patients are encouraged to work to change their lifestyle and implement healthier diet and exercise habits.
However, it is clear this patient population is in desperate need of other options. Thankfully, a new investigational therapy has just moved to a Phase 2 trial.
A New Phase 2 Trial
The FDA has just announced that CytoDyn Inc. is clear to start enrollment in their Phase 2 trial for NASH. This investigation will examine the effect of Leronlimab (PRO 140) as a treatment option for controlling liver fibrosis.
The company says they are “cautiously optimistic” about PRO 140’s potential. This study will investigate both its safety and efficacy in adult patients diagnosed with NASH.
The trial will include a total of 60 patients. It will be conducted as multiple centers and all patients will be randomized to receive either PRO 140 or placebo. This Phase 2 trial is double-blind.
About PRO 140
PRO 140 has already been given Fast Track Designation for HIV and metastatic triple-negative breast cancer. It works by blocking CCR5 which is a cellular receptor prevalent in HIV, tumor metastases, NASH, as well as other conditions.
In total, PRO 140 has been tested in 9 clinical trials, which have included 800 participants.
Stay tuned to hear more about this Phase 2 investigation. Hopefully, this therapy will continue to show efficacy and NASH patients will have a therapeutic option in the near future.
You can read more about this new trial here.